Clinical Research Directory

The HEARTFELT Study

This pragmatic randomized crossover trial looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the development of peripheral edema in patients with heart failure (HF). The hypothesis is that this passive measurement method will lead to better data availability, which in turn will improve patient care and reduce hospitalizations for the management of worsening HF (HF hospitalizations, HFHs) in nonadherent participants with chronic HF. The study objectives are: * Primary objective: Establish if the Heartfelt device is safe to use and effective at reducing HFHs. * Secondary objectives: 1. Establish the effect of the Heartfelt device on data availability compared to existing remote monitoring devices. 2. Establish the effect of the Heartfelt device on HF clinical outcomes. Participants will need to: * Install the device in their home for at least a year and up to 4 additional years after. * Reply to remote patient monitoring phone calls to follow the care plans.

Acetazolamide Per os for Decompensation of Heart Failure

The main causes of chronic heart failure (CHF) are arterial hypertension and coronary artery disease, less often cardiomyopathy, pericarditis, metastatic myocardial lesions. It should be noted that up to 50% of patients have a preserved left ventricular ejection fraction (LVEF), while its prevalence is progressively increasing annually. Acute decompensation of CHF is understood as a rapid increase in the severity of clinical manifestations (shortness of breath, severe arterial hypoxemia, the occurrence of arterial hypotension), which caused urgent medical treatment and emergency hospitalization in a patient already suffering from CHF. Decompensation of CHF requires intensification of treatment in order to stabilize the patient's condition. Strengthening diuretic therapy in addition to standard therapy helps to reduce edematous syndrome.

Vericiguat Use and Incident Atrial Fibrillation in Chronic Heart Failure

This ambispective observational cohort study aims to evaluate the association between vericiguat treatment and incident atrial fibrillation in patients with chronic heart failure. Adult patients treated at Beijing Tsinghua Changgung Hospital between November 2023 and December 2026 will be included, with data collected retrospectively before January 2025 and prospectively thereafter. Patients will be classified according to vericiguat use during routine clinical care. The non-vericiguat group will include patients receiving contemporary guideline-directed medical therapy for chronic heart failure without vericiguat. Treatment decisions will be made by treating physicians rather than assigned by the study investigators. The primary outcome is incident atrial fibrillation during follow-up, including atrial fibrillation, atrial flutter, and subclinical atrial fibrillation. Secondary outcomes include all-cause death and major adverse cardiovascular events.

Voice-based Outcome Identification and Clinical Evaluation in Heart Failure

VOICE-HF is a clinical study designed to evaluate the performance of a novel non-invasive software device (Noah Labs Vox) that uses vocal characteristics to estimate DHF risk and has strong potential for clinical success. This study will compare the performance of Noah Labs Vox with the contemporary performance of commonly used weight-based remote monitoring rules and applications to determine efficacy and safety.

Wearable Tissue Oximetry During Arm Cuff Occlusion, Walking, and Standing Tests in Outpatients With Chronic Heart Failure

This prospective, single-center, observational pilot study evaluated an investigational wearable tissue oximeter (NIRSense Argus Oximetry System, also called Envello Core) in adult outpatients with chronic heart failure in New York Heart Association (NYHA) class I, II, or III at Jackson Heart Clinic in Jackson, Mississippi. During one routine clinic visit, participants wore three adhesive optical sensors, on the forearm, the thigh, and the sternum, while completing three standard tests: a blood pressure cuff occlusion of the arm (vascular occlusion test), a six-minute walk test, and a change from lying down to standing. The sensors use near-infrared spectroscopy to record changes in tissue oxygenation. The study compared tissue oxygenation responses across NYHA classes and with standard clinical measures (blood pressure, pulse rate, pulse oximetry, and walk distance). Participation added about 30 minutes to the visit, with no follow-up. Fifty participants were enrolled. No treatment decisions were based on the study device.

Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure

The purpose of this study is to determine whether people with CHF, who often have different gut bacteria from healthy, would benefit from replacing their gut bacteria with healthy donor bacteria (also known as Intestinal Microbiota Transplantation - IMT). IMT aims to restore healthy gut bacteria in patients with CHF, with previous studies showing its effectiveness, but further research is needed. IMT is an approved treatment for patients with infectious diarrhea. More than 10,000 IMTs are performed every year in the US. However IMT is not approved for patients with CHF, and thus considered investigational.

Multiple-biomarker Approach for Individualized Treatment of Heart Failure With Preserved Ejection Fraction

The primary objective is to investigate the association between temporal evolutions of blood biomarkers and clinical adverse events, in order to produce a dynamic, individual, and accurate prediction model for patients with HFpEF. Moreover several secondary objectives will be investigated.

Assessment of Continuous Measurement of Transcutaneous CO2 for Evaluation of Alveolar Dead Space During Exercise

The study aim is to monitor, during exercise tests carried out in various conditions, the alveolar dead space, by means of continuous transcutaneous measurement of Pt CO2, which would be used as a surrogate for arterial PaCO2. Validity of this measurement needs to be assessed against arterial sampling (either arterial, or arterialized capillary), especially with regards to the lag time required by the CO2 diffusion from the arterial compartment (PaCO2) to the cutaneous one (PtCO2), in particular when rapid changes of CO2 might be induced by exercise. The evaluation will be done in 2 different settings: * intensive care patients, equipped, for their routine clinical care, with an arterial line; this allows for a precise timed comparison between PaCO2 and PtCO2 readouts; * routine exercise test, where blood gas evaluation is done essentially by means of arterialized earlobe capillary sampling. Following assessment of validity of the measurement (and the lag time PaCO2-PtCO2 which might be necessary to introduce as a correction), evolution of dead space during excise test will be tested in different conditions: Healthy subjects, patients with Chronic Obstructive Pulmonary Disease (COPD), chronic heart failure (CHF), hyperventilation, Pulmonary artery hypertension (PAH), or interstitial lung disease (ILD)

Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure

The goal of this clinical trial is to learn if the IV Iron treatment ferric derisomaltose helps in the treatment of chronic heart failure in people with iron deficiency. The main question it aims to answer is: • How many participants are admitted to the hospital or die from a disease in the heart or blood vessels Researchers will compare treatment with ferric derisomaltose to no treatment with ferric derisomaltose. This will be done to see how well ferric derisomaltose works. Participants will: * Be randomized 50/50 to either treatment with Ferric derisomaltose or to no treatment with ferric derisomaltose * All participants receives standard of care * Visit site 4-5 times and have 7 video/phone-calls

Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF

The goal of this fully-remote randomized controlled trial is to test the efficacy of Mindful Steps in facilitating physical activity compared to usual standard of care among 136 patients with COPD and/or HF. The main question it aims to answer is can this intervention promote physical activity as measured by daily step counts in sedentary patients with COPD and/or HF. Participants will be randomized (1:1 ratio) to receive either the Mindful Steps intervention or usual care for 12 months, with both arms receiving a Walking for Health education booklet.

Vericiguat and Reverse Remodeling Indices in Heart Failure

The goal of this clinical trial is to investigate how vericiguat benefits adults with stable heart failure with reduced ejection fraction (HFrEF) who are already receiving guideline-directed medical therapy. The main questions are: * Does vericiguat improve right ventricular systolic function, measured by fractional area change (FAC)? * Does vericiguat favourably influence myocardial remodeling, fibrosis, angiogenesis, inflammation, metabolism, renal function, and hematologic balance? * Do genetic and oxidative stress profiles modify treatment response? Researchers will compare a group receiving vericiguat plus usual care with a group receiving usual care alone to assess structural, functional, and biomarker changes over 12 months. Participants will: * Have blood drawn at baseline and follow-up visits for biomarker, metabolomic, genetic, transcriptomic, and hematologic analyses, including platelet function testing * Perform oral glucose tolerance tests (OGTT) to assess insulin resistance * Undergo echocardiography, cardiac magnetic resonance imaging, and cardiac scintigraphy to evaluate heart structure, function, and perfusion * Attend follow-up visits at 1, 3, 6, and 12 months Open-label extension: After the 12-month randomized phase, participants originally assigned to usual care will be offered open-label vericiguat and followed for an additional 12 months. This exploratory extension will reassess study outcomes to evaluate the consistency and magnitude of response to vericiguat in the prior control cohort.

Real-World Effectiveness and Costs of Yiqi Fumai Lyophilized Injection in Coronary Heart Disease-Related Chronic Heart Failure

This two-center retrospective cohort study will use de-identified electronic health records from June 1, 2021 through June 1, 2026 to compare patients with coronary heart disease-related chronic left ventricular dysfunction or chronic heart failure and Qi and Yin deficiency syndrome who initiated Yiqi Fumai lyophilized injection within 24 hours after a common time zero with eligible patients who did not initiate the drug within 24 hours. Treatment was determined during routine care and was not assigned by the researchers. The planned cohort includes 200 randomly sampled records, comprising 150 initiators and 50 non-initiators. The primary economic outcome is total direct medical cost during the index hospitalization, and the primary comparative-effectiveness outcome is heart-failure-related rehospitalization within 90 days after time zero. Baseline differences will be addressed primarily using propensity-score overlap weighting.

Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction

This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-861 administered once daily for 12 weeks in subjects with heart failure with reduced ejection fraction (HFrEF) who are on a stable, guideline-directed medical therapy for heart failure.

Evaluation of the Clinical Value of NT-proBNP (or BNP) Measurement, Alone or in Combination With the EPOF Questionnaire, for the Screening of Chronic Heart Failure (CHF) in Adults Aged 40 Years and Older Referred for a Cardiology Consultation Without Suspected CHF.

This observational study aims to evaluate whether measuring NT-proBNP (or BNP), either on its own or alongside the EPOF questionnaire, can improve the early detection of chronic heart failure (CHF) in adults aged 40 years or over who are referred for an outpatient cardiology evaluation and have no known or suspected CHF. The study will address the following questions: Does systematic NT-proBNP (or BNP) testing help to identify previously unrecognised CHF? Does combining NT-proBNP (or BNP) with the EPOF questionnaire enhance diagnostic accuracy compared with using each tool alone? Participants will attend their routine cardiology consultation, complete the EPOF questionnaire and undergo NT-proBNP (or BNP) testing as part of the clinical assessment. They will also allow the collection of relevant medical data. The diagnostic performance of these tools will then be compared with the final diagnosis made by the outpatient cardiologist. The study focuses on a population referred from primary care with increased cardiovascular risk. The early use of simple, accessible tools could reduce diagnostic delays, improve referral appropriateness and facilitate the earlier detection of CHF in general practice.

Yiqi Fumai Lyophilized Injection for Chronic Heart Failure Caused by Coronary Heart Disease

This study will evaluate whether adding Yiqi Fumai lyophilized injection to stable guideline-directed treatment improves symptoms, physical limitations, and NT-proBNP in adults with stable chronic heart failure caused by coronary heart disease. About 100 participants at four hospitals in China will receive 8 vials of Yiqi Fumai once daily by intravenous infusion for a planned 10 days. The two main outcomes will be the proportion of participants with at least a 5-point improvement in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and the proportion with at least a 30% decrease in NT-proBNP at the Day 11 end-of-treatment visit after the 10-day treatment course. Participants will be followed through Day 90 for heart function, exercise capacity, quality of life, safety, healthcare use, costs, and clinical events. A randomly selected subgroup of 50 participants will provide paired blood samples on Day 1 before the first infusion and on Day 11 at the end-of-treatment visit for exploratory transcriptomic, proteomic, and metabolomic analyses.

A Study Evaluating an Implantable Cardiac Microcurrent Device in Patients With Chronic Heart Failure

This study evaluates the safety and performance/effectiveness of the C-MIC System, an active implantable medical device designed to treat patients with heart failure with reduced ejection fraction (HFrEF). The system delivers a non-excitatory, constant direct electrical microcurrent (DC) to the heart with the aim of improving cardiac function. The C-MIC System is intended for use in patients with ischemic or non-ischemic dilated cardiomyopathy who have symptomatic, ambulatory heart failure despite receiving guideline-directed medical therapy. Eligible patients must have a left ventricular ejection fraction (LVEF) between ≥20% and ≤40%. The device is implanted in the catheterization laboratory using a minimally invasive procedure that does not require open-heart surgery. Following implantation, patients receive C-MIC Therapy for a duration of six months. The therapy is designed to improve left ventricular performance, as well as functional capacity and patient well-being, including 6-minute walk distance, quality of life, and New York Heart Association (NYHA) functional class.

Endocalyx for Heart Failure

The goal of this randomized, double-blind, placebo-controlled study is to assess whether the food supplement Endocalyx Pro reduces sodium and water excess in patients with chronic heart failure. The main questions it aims to answer are: 1. To assess whether the food supplement Endocalyx reduces sodium and water excess in patients with chronic heart failure. 2. To determine the contribution of different potential working mechanisms of Endocalyx in heart failure patients. 3. To evaluate whether the food supplement Endocalyx will improve patient-reported outcomes such as fluid overload symptoms and quality of life. 4. To confirm the previously demonstrated safety of Endocalyx in subjects with chronic heart failure. Participants will be randomized to Endocalyx Pro or Placebo daily for 8 weeks, and will be followed 12 weeks.

Effects of Resistance Training on Sarcopenia in Older Patients With Chronic Heart Failure

The goal of study is to evaluate the effects of an eight-week machine-based resistance training program on managing sarcopenia in older outpatients with chronic heart failure (HF) at Military Hospital 175.

TELEREHAB-BR: Cardiovascular Rehabilitation Models Trial

Introduction: Cardiovascular diseases remain the leading cause of mortality worldwide. Despite the proven effectiveness of cardiac rehabilitation (CR) programs, adherence remains unsatisfactory, especially in public healthcare systems such as the Brazilian Unified Health System (Sistema Único de Saúde - SUS), due to logistical, geographical, and socioeconomic barriers. In this context, cardiac telerehabilitation (CTR) has emerged as a promising alternative, with effectiveness comparable to traditional center-based cardiac rehabilitation. However, evidence regarding hybrid cardiac telerehabilitation models applicable to the Brazilian context, using simple and low-cost technologies, remains scarce. Objectives: To investigate adherence and its effects on the effectiveness, safety, and maintenance of exercise practice across different models of cardiac rehabilitation, with emphasis on the development and implementation of a hybrid cardiac telerehabilitation (HCTR) model adapted to the Brazilian context. The primary outcome will be adherence to the exercise program, defined as participation in at least 75% of the proposed sessions during the 12-week intervention. Secondary outcomes will include estimated cardiorespiratory fitness, functional capacity, functional mobility, handgrip strength, and health-related quality of life. Adverse events, digital health literacy, exercise maintenance, hospitalizations, and benefits and barriers to exercise will be evaluated as exploratory variables. Methods: This is a pragmatic, single-center, three-arm parallel randomized clinical trial consisting of hybrid cardiac telerehabilitation (HCTR), traditional center-based cardiac rehabilitation (TCR), and a usual care (UC) group. A total of 219 participants with coronary artery disease, with or without acute coronary syndrome, and/or stable heart failure, who are eligible for Phase II cardiac rehabilitation and receiving care through the Brazilian Unified Health System (Sistema Único de Saúde - SUS), will be enrolled.All participants will undergo standardized clinical and functional assessments at baseline, post-intervention, and short-term follow-up. Clinical screening and exercise stress testing will be performed at the Santa Catarina Institute of Cardiology (Instituto de Cardiologia de Santa Catarina - ICSC), whereas physical assessments and interventions will be conducted at the Center for Cardio-Oncology and Exercise Medicine (Núcleo de Cardio-Oncologia e Medicina do Exercício - NCME), State University of Santa Catarina (UDESC). The intervention will last 12 weeks, followed by an additional 12-week short-term follow-up period. Participants allocated to the HCTR group will receive a hybrid intervention consisting of face-to-face sessions, synchronous sessions supervised through videoconferencing, and remotely monitored asynchronous activities. Participants in the TCR group will participate exclusively in supervised face-to-face sessions, whereas participants in the UC group will receive usual clinical care, including conventional clinical guidance and an educational booklet. Study Significance: This clinical trial aims to generate evidence regarding adherence, effectiveness, safety, and maintenance of exercise practice across different models of cardiac rehabilitation. Furthermore, it seeks to provide evidence to support the development and implementation of a hybrid cardiac telerehabilitation model adapted to the Brazilian context and the Brazilian Unified Health System (SUS), contributing to expanding access to cardiac rehabilitation through accessible digital technologies.

A Study to Evaluate the Safety, Pharmacokinetics of AD-118 and AD-1181 in Healthy Adult Subjects

A Study to Evaluate the Safety and Pharmacokinetics of AD-118 and AD-1181 Under Fasted Conditions in Healthy Adult Subjects

Vericiguat and Exercise Hemodynamics in Patients With HFrEF

Heart failure with reduced ejection fraction (HFrEF) is associated with impaired exercise capacity and abnormal exercise hemodynamics despite contemporary guideline-directed medical therapy (GDMT). Vericiguat, a soluble guanylate cyclase stimulator, has demonstrated clinical benefits in selected patients with HFrEF, but its effects on exercise physiology remain incompletely understood. The EVERHETT-HF study is a prospective observational cohort study designed to evaluate the effects of treatment with vericiguat on exercise capacity and invasive exercise hemodynamics in patients with stable HFrEF receiving maximally tolerated guideline-directed medical therapy (GDMT). Participants undergo comprehensive cardiopulmonary exercise testing (CPET) and exercise right heart catheterization (ERHC) to assess functional and hemodynamic responses during exercise.

Emulation of the EMPEROR-Reduced Trial Using Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Emulation of the EMPEROR-Preserved Trial Using Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

A Phase IIb Study of AZD5462 in Patients With Chronic Heart Failure

The main purpose of this study is to evaluate the effect of AZD5462 on cardiac function in participants with chronic heart failure (HF).