Clinical Research Directory

Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy. Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management.

RESPONDER-HF Trial

Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization

Data-Driven Phenotyping in Heart Failure With Preserved Ejection Fraction

The goal of this observational study is to learn how people with Heart Failure with Preserved Ejection Fraction (HFpEF) can be grouped into different "phenotypes" based on their clinical information. The researchers want to understand whether these groups have different health profiles and different responses during a cardiopulmonary exercise test (CPET). The main questions this study aims to answer are: * Can clinical data be used to identify meaningful HFpEF phenotypes? * Do these phenotypes match well-known HFpEF scores, such as the H2FPEF and Heart Failure Association Pre-test Assessment, Echocardiography and Natriuretic Peptide (HFA-PEFF) scores? * Do people in different phenotypes show different results on a CPET? Participants will: * Have their past clinical records reviewed if they were diagnosed with HFpEF at the Local Health Unit of the Leiria Region (ULS RL); * A smaller group will attend one visit to complete a CPET, which measures how the heart, lungs and muscles respond during exercise. This study includes adults aged 18 years or older who have HFpEF. The study does not involve any new treatments or experimental drugs.

Associations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status

The purpose of the study is to determine associations between fitness status, bacteria in the mouth, and the blood flow to muscle. This study is trying to find out if fitness status impacts the bacteria that are present in the oral microbiome (environment in the mouth) or the ability of the body to send blood to the skeletal muscle. Participants will complete all or some of the following: * A mouth swab to assess the bacteria in their mouths. * Produce a saliva sample into a tube. * Cycle on a bike until you reach maximum effort. * Undergo blood draws * Wear a 24-hour non-invasive device that monitors blood pressure. * Drink 70mL (1/3 of a cup) of concentrated beetroot juice once

A Preliminary Study for INFORMED

Investigators will determine whether N-of-1 trials, as a pragmatic, participant-centered approach to medication optimization that can overcome key barriers of deprescribing, can lead to increased participant confidence regarding their preference to continue or discontinue beta-blockers in older adults with Heart Failure with Preserved Ejection Fraction (HFpEF).

A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction

Heart failure with preserved ejection fraction (HFpEF) is a common and serious complication of obesity and type 2 diabetes (T2D). HFpEF occurs when the heart muscle unable to relax efficiently to pump the blood around the body. This leads to fluid build-up, breathlessness and inability to tolerate physical exertion. People who develop HFpEF do less well because treatment options are limited. Pilot data in patients with obesity and diabetes and a small number of patients with HFpEF have shown improvements in exercise capacity and reversal of changes in the heart and blood vessels. This study will assess if this is achievable in a multi-ethnic cohort of patients with established HFpEF. A total of 63 adults will be invited and allocate by chance into two groups: 1) 12-weeks of a low calorie diet or 2) Standard care and health advice on how to lose weight followed by the option to have the low calorie diet after 12-weeks. The study will determine if weight loss over 12 weeks can improve heart function, symptoms and ability to exercise. Additionally, participants' views on changing their diet and how this has impacted their symptoms will be sought during the study in an optional interview. This will help guide treatments planning in the future to get maximum benefits, and to individualize support to patients from different cultural backgrounds.

Comparative Efficacy and Safety of Acetazolamide Versus Metolazone as an Adjunct to Standard Therapy in Patients With Acute Decompensated Heart Failure

This clinical trial aims to compare the efficacy and safety of acetazolamide versus metolazone as adjunctive treatments to standard therapy in patients with acute decompensated heart failure (ADHF). ADHF is a life-threatening condition, and current treatments often involve loop diuretics to alleviate volume overload. This study will assess the added benefit of acetazolamide and metolazone in improving decongestion, reducing hospital stays, and preventing complications such as renal dysfunction or electrolyte imbalances. Participants will be randomized to receive either acetazolamide or metolazone in addition to standard diuretic therapy. The trial will evaluate primary outcomes including successful decongestion, in-hospital mortality, and length of hospital stay, with secondary outcomes focusing on renal function, electrolyte disturbances, and overall safety. The study is conducted at Bahawal Victoria Hospital, Bahawalpur, and aims to provide valuable insights into the management of ADHF, especially in the Pakistani population.

Chronic Exogenous Ketosis in HFpEF

The goal of this clinical research study is to test what effects a ketone drink will have in people with heart failure with preserved ejection fraction (HFpEF), including on exercise and heart function. Patients with HFpEF often have difficulty exercising, and our goal is to understand whether a ketone drink changes much patients can exercise. The study has three visits, including a baseline visit to assess for study eligibility, and two visits (one after 8 weeks of a ketone drink or a placebo drink, and another one after 8 weeks of whichever drink the participant did not receive the first time).

Prevalence and Risk Factors asSOciated With CArdiac comorbiDIty in psoriAsis

In a prospective cohort study (n = 1.000), the investigators aim to investigate the correlation between cardiac biomarkers and advanced echocardiography and determine whether these are prognostic markers of heart disease in patients suffering from psoriasis.

HIDRAdenitis Suppurativa and HEART Disease

In a prospective observational cohort study (n = 250) the investigators aim to assess the correlation between cardiac biomarkers, advanced echocardiography and HS severity and determine whether these are prognostic markers of heart disease in patients suffering from hidradenitis suppurativa (HS).

Pilot Study Lp299v Supplementation in Chronic Heart Failure

The goal of this study is to determine the impact of 12 weeks of Lp299v supplementation (20 million cfu/day vs. placebo) on exercise capacity, circulating biomarkers of cardiac remodeling, quality of life, and vascular endothelial function in humans with heart failure and reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) who have evidence of residual inflammation based on an elevated C-reactive protein level. This will be done in the setting of a randomized, double-blind, placebo-controlled trial.

AB-1002 in Patients With Class III Heart Failure

This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of AB-1002 in patients with NYHA Class III heart failure. Patients with non-ischemic cardiomyopathy will be enrolled until up to 17 subjects have received infusions of investigational product. All patients will be followed until 12 months post treatment intervention, and then undergo long-term follow-up via semi-structured telephone questionnaires every 6 months for an additional 24 months (+/- 30 days).

Cardiac Structure and Function in Patients with Cystic Fibrosis

In a prospective observational cohort study (n = 100), the investigators aim to assess the correlation between cardiac biomarkers, advanced echocardiography and cystic fibrosis genotype and severity and determine whether these are prognostic markers of heart disease in patients suffering from cystic fibrosis (CF).

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.

Mechanisms of Exercise Intolerance in Heart Failure With Preserved Ejection Fraction

The global objective of this study is to determine the mechanisms of exercise intolerance and dyspnea on exertion (DOE) in patients with HFpEF and based on this pathophysiology, test whether specific exercise training programs (whole body vs single leg) will result in improved exercise tolerance.

Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF

Recent studies have shown that transthyretin amyloidosis (ATTR) can sometimes cause a type of heart failure where the pumping function of the heart is normal, also known as Heart Failure with Preserved Ejection Fraction (HFpEF) or diastolic heart failure. In this single center diagnostic study, we will evaluate for ATTR in patients with HFpEF in order to to determine how frequently this occurs and how we can predict which heart failure patients may have TTR amyloidosis. Our goal is to identify amyloidosis in heart failure patients earlier so that they can start treatment.

Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction

Heart failure (HF) with a left ventricular ejection fraction (LVEF) \>0.40 is a large medical problem, for which no drug or device has a recommendation in current HF guidelines. The prevalence of mortality and HF hospitalizations in HF with LVEF \>0.40 is high, but the identification of predictors for increased risk of mortality and HF hospitalizations in this patient category remains difficult. The hypothesis of this study is that the risk of all-cause mortality and HF hospitalizations can be measured by clinical factors, imaging parameters and circulating biomarkers, and that these factors can be used in a risk profile

Assessment of Left Ventricular Filling Pressure by Applying Artificial Intelligence Algorithms to Left Atrial Speckle-tracking Echocardiography

The goal of this single-center, prospective, observational study is to validate a software package based on an artificial intelligence algorithm for automated non-invasive estimation of LVFP against invasively measured ones by left and right heart catheterization; In addition, the added value of this new automated software to detect increased LVEDP \> 15 mm Hg compared to the current ASE/EACVI algorithm for assessing diastolic dysfunction and longitudinal left atrial strain during the reservoir phase will be evaluated.

The Relationship Between Inflammatory ARTritis and CArdiac DIseAse

The goal of this prospective cohort study is to investigate cardiac comorbidity in a random sample of approximately 1200 patients from a population of outpatients with rheumatoid arthritis and axial spondyloarthritis referred to collectively as inflammatory arthritis (IA). The main questions it aims to answer are: * Using conventional echocardiography, the investigators aim to determine the prevalence of overt and asymptomatic cardiac dysfunction in a large random sample of outpatients with IA. Cardiac dysfunction will be evaluated by echocardiography and cardiac biomarkers (NT-pro-BNP, hs-TNT and hs-CRP). * In patients without known heart disease: Using 2, 5 and 10 year follow-up, the investigators aim to examine if advanced echocardiography can be used to detect early signs of heart disease by investigating the clinical significance of adding deformation measures - alone and in combination with selected biomarkers - to conventional risk factors in the cardiac risk assessment of patients with IA Participants will undergo an echocardiographic examination in combination with a general health assessment including obtainment of cardiac biomarkers and a electrocardiogram. Using advanced echocardiography - Tissue Doppler Imaging, 2- dimensional speckle tracking echocardiography, 3D-echocardiography and 3-dimensional speckle tracking echocardiography - the investigators also aim to compare myocardial deformation parameters of patients with IA to a gender and age matched control group without IA from the Copenhagen City Heart Study.

Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction

The goal of this clinical trial is to test an experimental gene therapy in participants with heart failure with preserved ejection fraction, also known as diastolic heart failure. The main questions it aims to answer are: * safety and tolerability of the gene therapy; and * whether the gene therapy helps the heart ventricles relax during filling. Participants will undergo a one-time infusion of the gene therapy in the cardiac catheterization laboratory and then be followed for safety and effects on left-sided filling pressures while exercising. The first year will have multiple in-person visits followed by 4 years of biannual phone calls.

Multimodality Imaging in the Screening, Diagnosis and Risk StratifictiON of HFpEF

The incidence of Heart failure with preserved ejection fraction (HFpEF) in Heart failure patients increases rapidly. However, the current clinical awareness is insufficient, and the cardiac structural and functional injury are not well understood. It is difficult to recognize the subclinical changes of the cardiac in the early stage with conventional imaging techniques, and it is common to ignore the existence of the clinical alterations. This study aimed to investigate the cardiac features, early diagnosis and risk factors of HFpEF patients, based on the multi-modal (Magnetic resonance imaging- nuclear medicine imaging- echocardiography) imaging, combined with large data and artificial intelligence. This study will provide deep insights into the HFpEF derived from different causes.

Diagnosis and OutcoMes evaluAtIoN of Multicenter Patients With HFpEF Using Multimodality Imaging

The incidence of Heart failure with preserved ejection fraction (HFpEF) in Heart failure patients increases rapidly. However, the current clinical awareness is insufficient, and the cardiac structural and functional injury are not well understood. It is difficult to recognize the subclinical changes of the cardiac in the early stage with conventional imaging techniques, and it is common to ignore the existence of the clinical alterations. This study aimed to investigate the cardiac features, early diagnosis and risk factors of HFpEF patients, based on the multi-modality (Magnetic resonance imaging- nuclear medicine imaging- echocardiography) imaging and multicenter study, combined with large data and artificial intelligence. This study will provide deep insights into the HFpEF in multicenter population.