Clinical Research Directory

Feasibility of The Health Integrated Nutrition and Kidney Wellness Program

Purpose of the Study: This clinical trial will test whether a nutrition and kidney health program can work well for adults with kidney disease. The program was created with help from patients and community partners. Main Questions: How many eligible patients choose to join the program? How many participants finish the full 12-week program? How satisfied are participants with the program? What Participants Will Do: Participants will be assigned to a diet-focused lifestyle education series (THINK-Well Intervention) or enhance usual care. THINK-Well Intervention group will take part in 7 group education sessions over 12 weeks. Sessions will be online and in-person. Topics include eating to promote heart-kidney-and metabolic health, managing long-term health conditions, setting health goals, and sharing experiences with others who have chronic disease. Participants will practice meal preparation through cooking classes and have opportunity to apply lessons on choosing whole foods with food bucks provided. The enhanced usual care group will receive two virtual nutrition education sessions led by a trained educator over 12 weeks. Topics will be similar to standard education provided to people with kidney disease managed by a kidney doctor. Topics will be adapted from established resources from the National Kidney Foundation, American Kidney Fund, and American Heart Association.

Awareness of Risk Factors and Perception of Cardiovascular Risk in Secondary Prevention: A Comparison Between Women and Men

The present research project aims to assess, through a survey, awareness of general and sex/gender-specific cardiovascular risk factors, as well as the perception of the risk of developing further cardiovascular diseases, among patients in secondary prevention.

Heart Health Study in Washington D.C. to Develop a Community-Based Behavioral Weight Loss Intervention

Background: \- Past studies suggest that the best way to improve heart health in the Black community is through community-based programs. Researchers will partner with DC community leaders. They will collect information about the health and health needs of people in mostly Black churches in DC. They will study things that affect heart health, like diabetes, blood pressure, cholesterol, and weight. They will also study how technology can keep track of activities and health. The information will show the health needs of church-based communities or faith-based organizations. Objectives: \- The primary objective of this study is to estimate the percentage of the population that meet ideal, intermediate, and poor criteria for each of the cardiovascular health factors (BMI, physical activity, dietary intake, blood pressure, total cholesterol, fasting plasma glucose, and cigarette smoking) in churches or faith-based organizations in the DMV area. This data will inform the design and implementation of a behavioral weight-loss intervention within the faith-based community immediately following this study. The secondary objectives are to: 1) evaluate usage of handheld devices for objectively measuring physical activity and dietary intake; 2) evaluate usage of web-based technology for monitoring cardiovascular health markers, including dietary intake; 3) examine referral methods for untreated hypertension, diabetes, and hypercholesterolemia; 4) compare lifestyle behaviors across levels of psychosocial factors, cultural norms, and neighborhood environment factors; and 5) formalize a community advisory board involved in the implementation of the health screening and needs assessment program and a future behavioral weight-loss intervention. Eligibility: \- Adults ages 19 to 85 who attend one of the study churches. Design: * Participants will visit their church for a 4-hour health exam. They will have their blood pressure and body measurements taken. They will have a drop of blood taken from their finger with a small needle. This blood will be tested for blood sugar and cholesterol. Participants will be given the results of these tests. * Participants will answer questions about their health. * All participants will be given an activity monitor to wear for 1 month. The activity monitor is worn around the wrist. Some participants will also receive an activity monitor that is worn around the waist. Participants will be given instructions on how to wear the activity monitors and follow the results on a website. * At the end of 1 month, participants will return one device (they can keep the other). They may receive a gift card for completing the study.

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers

Background: Heart disease is the leading cause of death, disability, and healthcare expense in the United States. Researchers think a new drug called Fx-5A may be useful to treat different cardiovascular diseases and inflammation. Objective: To understand the safety, tolerability, and effects of Fx-5A. Eligibility: Healthy people ages 18 and older who are not pregnant Design: Participants will be screened with: Medical history Physical exam Blood tests Pregnancy test for female participants Participants will stay in the hospital for 36-48 hours. This will include: Blood tests EKGs: Electrodes will be placed on the participant s chest. The patches are connected to cables that will send information from their heart to a machine. Single infusion of Fx-5A. A needle will be used to insert a plastic tube into a vein in the participant s arm. This tube will remain in the arm for the duration of the hospital stay for blood tests. Participants will have follow-up visits day 7 and day 28 after their infusion. At these visits, they will have blood tests and an EKG. Participation will last 5-10 weeks.

Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks

Background: The adrenal gland makes the hormone aldosterone. This helps regulate blood pressure. An adrenal gland tumor that makes too much aldosterone can cause high blood pressure and low potassium. The cause of these tumors is unknown, but sometimes they are inherited. Objective: To study the genes that may cause primary aldosteronism in Black individuals. Eligibility: People ages 18-70 who: Are Black, African American, or of Caribbean descent And have difficult to control blood pressure or primary aldosteronism Relatives of people with primary aldosteronism Design: Participants who are relatives of people with primary aldosteronism will have only 1 visit, with medical history and blood tests. Participants with primary aldosteronism or difficult to control blood pressure (suspected to possibly have primary aldosteronism) will be screened with a 1-2 hour visit. If they qualify, they will return for a hospital stay for 7-10 days. Tests may include: Medical history Physical exam Blood tests: Participants will have a small tube (IV catheter) inserted in a vein in the arm. They may drink a glucose-containing liquid or get a salt solution. If medically indicated, they may have invasive blood tests with a separate consent. Urine tests: Some require a high-salt diet for 3 days. Heart tests Scans: Participants lie in a machine that takes pictures of the body. A dye may be injected through a vein. Small hair sample taken from near the scalp. Kidney ultrasound Bone density scan: Participants lie on a table while a camera passes over the body. If the doctors feel it is medically necessary, they will offer participants treatment depending on their results. These treatments may cure the patient of their disease and may include: 1. Having one adrenal gland removed by the Endocrine surgeon under anesthesia. Patients will have follow-up visits 2-4 weeks after surgery. 2. Taking drugs to block the effects of aldosterone Participants may return about 1 year later to repeat testing.

The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD

Background: People with systemic lupus erythematosus (SLE) are at risk of developing complications in their blood vessels. This can increase the risk of heart attacks or stroke. No medications have been effective at reducing this risk in people with lupus. Objective: To test whether a drug (anifrolumab) can improve blood vessel function and reduce blood vessel inflammation in people with SLE. Eligibility: People aged 18 to 80 years with SLE. Design: Participants will undergo screening. They will have a physical exam. They will have blood and urine tests. They will have a test of their heart function and a chest X-ray. They will answer questions about their SLE symptoms. Participants will visit the clinic 9 times in 8 months. After screening, visits will be 4 weeks apart. Each visit may take up to 4 hours. Participants will receive infusions from a tube attached to a needle inserted into a vein in the arm (IV). Some will receive anifrolumab. Others will receive a placebo treatment. They will not know which one they are getting. At some visits they will have additional tests: CAVI (cardio-ankle vascular index) tests blood vessel function. Participants will lie still for 20 minutes. Small electrodes will be placed on both wrists with stickers. A microphone will be placed on their chest. Blood pressure cuffs will be wrapped around their ankles and arms. FDG-PET/CT is an imaging procedure. Participants will receive a substance through an IV line. They will lie on a table for 110 minutes while a machine captures images of their body.

Non-interventional Study on Guideline Directed Medical Therapy for Patients With Heart Failure (HF) in Germany

Heart failure (HF) is a global public health issue that affects more than 63 million people worldwide. The clinical and economic burden of HF on health care systems is substantial. Heart failure with reduced ejection fraction (HFrEF) represents approximately 50% of the HF patient population.The burden of HF is expected to increase substantially as the population ages, and despite improvements in treatment, hospitalisation and mortality rates remain especially high in HFrEF patients. The current guideline recommendation of directed medical therapy for HFrEF combines four drug classes with proven prognostic benefit: Angiotensin receptor-neprilysin inhibitor (ARNI)/angiotensin converting enzyme inhibitors (ACE I)/angiotensin receptor blockers (ARB), betablockers (BB), mineralocorticoid receptor antagonists (MRA), and sodium-glucose co-transporter 2 inhibitors (SGLT2i). The 2023 ESC (European Society of Cardiology) HF guideline update additionally recommends a rapid in-hospital sequencing approach of guideline-directed medical therapy (GDMT) with frequent physician visits during the first 6 weeks post discharge. Studies investigating the implementation of GDMT in a real-world setting have shown that a significant proportion of patients did not receive the recommended drug combination therapy. Delayed initiation of GDMT contributes to the low number of patients receiving guideline concordant HFrEF therapy, which ultimately may affect patient outcomes. One approach to implement the 2023 ESC guideline updates for heart failure treatment regarding early in-hospital initiation and rapid up-titration of GDMT could be to provide specific training on GDMT recommendations. Such a standardised training is offered to the physicians treating HF patients within selected hospitals of the German Helios hospital network (Helios-GDMT-program). Evidence is needed in order to assess whether in-hospital initiation and up-titration of all phenotype concordant classes of GDMT at hospital discharge can be observed after standardised physician training and whether the GDMT-program implementation also translates into real-world routine outpatient care with respect to use of GDMT and clinical outcomes.

Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients

The goal of this clinical trial is to learn if a new method of closing the breastbone after heart bypass surgery can improve healing and reduce complications in adults undergoing coronary artery bypass graft (CABG) surgery. The main questions it aims to answer are: Does this new closure method reduce infections and wound reopening? Does it improve healing, recovery, and overall patient outcomes? Researchers will compare patients who receive the new closure method to past patients who received the standard method to see if outcomes are better. Participants will: Receive the new closure method during their surgery (as part of standard care) Be followed during their normal recovery up to their 6-week follow-up visit Complete a short quality-of-life questionnaire (about 10 minutes) Have their recovery assessed, including healing, complications, and hospital use Researchers will also look at quality of life, heart complications, hospital readmissions, antibiotic use, scar appearance, and overall costs to understand the full impact of the new method.

OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events

The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp\[a\]).

Genetics of Obesity, Diabetes, and Heart Disease in African Diaspora Populations

Background: \- African Americans have one of the highest rates of type 2 diabetes in the United States, and often have other medical problems related to obesity and cardiovascular disease. These conditions have various risk factors, including high blood sugar levels, high cholesterol levels, and insulin resistance. However, these risk factors have not been studied very closely in individuals with African ancestry, including Afro-Caribbean and sub-Saharan Africa migrant populations. Researchers are interested in conducting a genetic study on obesity, adult-onset diabetes, heart disease, and other common health conditions in individuals with African ancestry. Objectives: \- To collect genetic and non-genetic information from individuals with African ancestry to study common health conditions related to obesity, adult-onset diabetes, and heart disease. Eligibility: \- Individuals at least 18 years of age who self-identify as African American, Afro-Caribbean, or migrants from sub Saharan Africa. Design: * Participants will undergo a physical examination and will provide a blood sample for study. * Participants will also answer questions about personal and family medical history and current lifestyle behaviors. * No treatment will be provided as part of this protocol.

Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults

Background: Omega-7 fatty acids are found in the oil extracted from certain fish and nuts like macadamia. Palmitoleic acid is one of the most common omega-7 fatty acids. Many studies suggest that this oil is good for heart health. Researchers want to find out more about these potential benefits. Objective: To study how oil enriched with palmitoleic acid (Omega-7 oil) affects metabolism. Eligibility: Healthy adults at least 18 years old with no known history of cardiovascular disease. Subjects not allergic to fish oil and fish products Females that are not pregnant and are not planning a pregnancy during the length of the study Design: Participants will be screened with questions about their health, medical history, and medicines they take. Participants will have 4 visits over 24 weeks. The visits may include: * Blood drawn from a vein in the arm by a needle stick. Sometimes participants will have to fast before the blood draw. * Vital signs (blood pressure, heart rate, and temperature) taken * Body mass index measured * Cardio-Ankle Vascular Index test may be performed. The stiffness of the participant s arteries will be measured by reading blood pressure in the arms and legs and monitoring the heart. * Optional stool samples * Pregnancy test * A short review of participants physical activity and diet * A supply of dietary supplements to take between visits. Participants will take 4 gel capsules a day. Participants will keep a food and exercise journal Compensation will be provided to subjects that complete the study Check your eligibility for this study by clicking here: https://www.surveymonkey.com/r/DietaryOmega

Effectiveness of Pollution Monitoring in Clinical Exercise Rehabilitation

The primary objective of EPIC-AIR is to evaluate the feasibility and potential effectiveness of integrating real-time air pollution monitoring into CR and PR programmes via an online platform that delivers both exercise prescription and air pollution guidance. Specific objectives are: (1) to determine whether access to real-time air quality data reduces personal pollution exposure (PM2.5, PM10, NO2) during outdoor physical activity in CR/PR patients and healthy volunteers; (2) to evaluate the usability and acceptability of the platform in a clinical rehabilitation context; (3) to assess the feasibility of the trial design, including recruitment, randomisation, retention, and adherence rates; (4) to measure the impact of the intervention on physical activity levels, health-related quality of life, and cardiovascular biomarkers; and (5) to inform the design and sample size of a future definitive randomised controlled trial.

Human Biospecimen Procurement Protocol: Biorepository to Support Translational Research to Identify Disease Mechanism(s)

Background: Studies show that rare genetic variants might lead to diseases. Researchers want to collect blood and tissue samples so they can study them and better understand diseases. Objective: To collect blood and tissue samples for studies to identify underlying causes of disease. Eligibility: People of all ages Design: Participants will have blood and/or tissue samples collected. Samples can be collected at the NIH Clinical Center. Participants doctors can collect the samples and send them to NIH. NIH staff can collect samples off site. For blood samples, blood is taken from an arm vein using a needle. Tissue collection may involve: Buccal smear: Cells are collected by scraping the inside of the cheek with a cotton swab. Saliva collection: Participants spit into a cup. Skin biopsy: A special needle takes a very small skin sample. Surgical waste tissue: If participants have surgery, NIH may receive samples of tissue that would routinely be removed. Umbilical cord or cord blood collection: If a participant has a baby, NIH may receive a small piece of the umbilical cord or blood from the cord once the baby is delivered.

Nutritional Effects in Cardiovascular Surgery

This study aims to investigate the distribution of gut microbiota-derived metabolites, and to evaluate whether postoperative nutritional intervention can modulate the gut-heart metabolic axis, thereby improving metabolic profiles and clinical outcomes.

Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia

DAN-ZOSTER is a nationwide randomized study investigating whether vaccination against herpes zoster (shingles) can reduce the risk of cardiovascular disease and dementia in older adults. Herpes zoster is caused by reactivation of the varicella-zoster virus and becomes more common with increasing age. Some observational studies have suggested that vaccination against herpes zoster may also lower the risk of heart attacks, strokes, and dementia, but this has not been confirmed in randomized clinical trials. In this study, approximately 162,000 adults aged 65 years or older living in Denmark will be randomly assigned to either receive the recombinant herpes zoster vaccine (Shingrix®) or receive no vaccine. Participants in the vaccine group will receive two doses given 2-6 months apart. Participants will be identified and invited using Danish national registries and digital mail systems. Information about health outcomes will be collected through nationwide health registries during follow-up. The main outcomes of the study are major cardiovascular events (heart attack, stroke, or cardiovascular death) and new diagnoses of dementia. The goal of the study is to determine whether herpes zoster vaccination can help prevent these conditions in older adults.

Impact of Combined Cardio-pulmonary Assessment on COPD Clinical Management.

The goal of this randomized clinical trial is to learn whether a combined cardio-pulmonary assessment improves cardiac function, exercise capacity, cardiac biomarkers and health-related quality of life in adults with mild-to-moderate chronic obstructive pulmonary disease (COPD) who are at high cardiovascular risk or have established cardiovascular disease. The main questions it aims to answer are: * Does the combined cardio-pulmonary assessment improve mean left ventricular ejection fraction (EF) over 12 months compared with standard respiratory care? * Does the combined cardio-pulmonary assessment improve mean 6-minute walk distance (6MWD) over 12 months compared with standard respiratory care? * Does the combined cardio-pulmonary assessment reduce mean NT-proBNP over 12 months compared with standard respiratory care? * Does the combined cardio-pulmonary assessment improve mean Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score over 12 months compared with standard respiratory care? Researchers will compare a combined cardio-pulmonary assessment to standard respiratory care to see whether the integrated approach leads to greater improvements in EF, 6MWD, NT-proBNP, and KCCQ-12. Participants will: * Be randomly assigned to receive either a combined cardio-pulmonary assessment or standard respiratory care * Complete a baseline visit that includes clinical assessment, respiratory function testing, blood tests (including NT-proBNP), a 6-minute walk test, and the KCCQ-12 questionnaire * Undergo cardiovascular evaluation (electrocardiogram and transthoracic echocardiography) if assigned to the combined assessment group * Attend follow-up evaluation at 12 months, repeating the same assessments according to their assigned group

Technical Development of Cardiovascular Magnetic Resonance Imaging

Background: In the U.S., over 6.5 million people have heart failure. Researchers want to develop new testing methods for cardiovascular problems using magnetic resonance imaging (MRI) to improve the clinical diagnosis and management of people with heart failure. Objective: To develop and test new methods for imaging the heart and blood vessels using MRI. Eligibility: People ages 18 years and older who are having an MRI of their heart or blood vessels. Healthy volunteers are also needed. Design: Participants will be screened with a medical history. Participants will have a physical exam and blood tests. They will have an electrocardiogram (ECG) to measure the heart s electrical activity. Then they will have their scheduled MRI scan. The MRI scanner is a large, hollow tube. Participants will lie on a table that moves in and out of the tube. During the MRI, they may have contrast dye injected through an intravenous line inserted into their arm or hand. ECG may be used to monitor their heartbeat or coordinate pictures with their heartbeat. A flexible belt may be used to monitor their breathing. A finger probe may be used to track their heart rate and/or oxygenation level. Their blood pressure may be measured. Pictures may be taken of their blood vessels, heart, and lungs before, during, and after they get medicine to increase blood flow. They may lie flat and pedal a stress bicycle to increase their heart rate. Participation will last for 5 years. During that time, participants may receive a yearly survey about their health. They may be contacted for an optional follow-up MRI within 2 years of their MRI.

Application of Non-inductive Intelligent Physical Sign Monitoring Equipment Based on Flexible Electronic Devices in the Diagnosis and Treatment of Cardiovascular Diseases

This project is a single-center clinical evaluation study designed to validate a non-invasive mattress-based smart monitoring system. The system is intended for installation on standard hospital beds to provide continuous, contact-free monitoring of vital signs, including heart rate, respiration, body temperature, and posture, in patients with cardiovascular diseases. The system will integrate monitoring data with hospital information systems and personal health platforms to support clinical management and remote health monitoring.

Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)

The Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study is an interdisciplinary, community-based, prospective longitudinal epidemiologic study examining the influences of race and socioeconomic status (SES) on the development of age-related health disparities among socioeconomically diverse African Americans and whites in Baltimore. This study investigates whether health disparities develop or persist due to differences in SES, differences in race, or their interaction. HANDLS is unique because it assesses physical parameters as well as evaluating genetic, biologic, demographic, and psychosocial parameters of African American and white participants over a wide range of socioeconomic statuses, longitudinally. HANDLS also employs novel research tools, mobile medical research vehicles, in hopes of improving participation rates and retention among non-traditional research participants. The domains of the HANDLS study include: nutrition, cognition, biologic biomarkers, body composition and bone quality, physical function and performance, psychology, genomics, neighborhood environment and cardiovascular disease. Utilizing data from these study domains will facilitate an understanding of selected underlying factors of persistent black-white health disparities in overall longevity, cardiovascular disease, and cognitive decline. HANDLS recruited a fixed cohort as an area probability sample of Baltimore City from August 2004 through November 2009 as Wave 1. HANDLS Wave 2 entitled The Association of Personality and Socioeconomic status with Health Status - An Interim Follow-up Study began in June 2006 under a separate protocol. It was designed as a follow-up telephone interview approximately 18 months after the initial examination (Wave 1) was complete. Wave 2 provided interim contact with study participants, and important interim information regarding their health. Now completed, waves 3, 4 and 5 were follow-up examinations visits to our mobile Medical Research Vehicles (MRVs). In September 2020, HANDLS initiated wave 6; telephone interviews and limited in-person visits as a COVID-centric protocol. The current protocol outlines Wave 7, the fourth follow-up examination and the participants' fifth visit to our mobile Medical Research Vehicles (MRVs). Planned as a follow-up after 3-4 years, Wave 7 consists of health examinations, questionnaires, sensory assessments (visual and olfactory), health literacy assessment, renal function assessments, environmental assessments, and for a sub-set of participants; structural MRIs, a personality inventory and an examination of sleep and cognition under separate protocols. HANDLS will resume in-person examinations with wave 7 in which we will prioritize contacting participants who were not seen in wave 5.

REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels

This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with cardiovascular disease. Participants will either get CagriSema or a dummy medicine (also called "placebo") which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will inject the study medicine once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for up to 4.5 years.

Single-tracer Multiparametric PET Imaging

The overarching goal of this project is to develop and evaluate a single-tracer multiparametric positron emission tomography (PET) imaging solution for simultaneous imaging of blood flow and glucose metabolism using 18F-fluorodeoxyglucose (FDG) alone. The investigators working hypothesis is that quantitative blood flow can be extracted from dynamic 18F-FDG PET data by use of tracer kinetic modeling, in addition to glucose metabolism that 18F-FDG is conventionally used for.

Century Trial, a Randomized Lifestyle Modification Study for Management of Stable Coronary Artery Disease

The Century Trial is a single center Phase III randomized study sponsored by the Albert Weatherhead III Foundation and conducted by Dr. K. Lance Gould. The study hypothesis is that a combined image-treatment regimen of PET + comprehensive program of lifestyle modification and lipid lowering drugs to target lipid level will result in an improved cardiovascular risk score when compared to current standard optimal medical therapy, potentially resulting in a lower rate of death, non-fatal myocardial infarction (MI) and revascularization procedures during long term follow-up when compared with current standard of care. If our hypothesis is correct, we will not only improve our ability to prevent and treat CAD but we will also illustrate that, even with the expenses of behavioral interventions and imaging techniques, we can be very cost effective. This information may help patients at risk or with known CAD to obtain insurance coverage to prevent the disease as well as providing a more effective way of treating it.

Mortality Reductions Based on AUD/Heavy Alcohol Use, HIV Risk, and Cardiovascular Risk

The purpose of this research study is to investigate if a personalized intervention including parts such as navigation (focus on patient outreach efforts, missed and completed encounters), personalization (individual health benefits) and compensation (value health-related costs borne by patients) will help people reduce their chances of dying from preventable causes, including heart attacks, strokes, drinking alcohol, substance abuse, HIV, and other conditions.

The Global Cardiovascular Risk Consortium

The Global Cardiovascular Risk Consortium (GCVRC) brings together harmonized individual-level data from currently more than 2 million (anticipated: approximately 3 million) individuals across 133 cohorts, 40 countries, and 6 continents, with recruitment ongoing. The GCVRC examines the impact of classical cardiovascular risk factors-such as body-mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes-on cardiovascular disease (CVD) and death from any cause worldwide.