Clinical Research Directory

Deprescribing Beta-Blockers in Elders With Heart Failure With Preserved Ejection Fraction (DEPRESCRIBE-HFpEF)

The goal of this study is to learn whether stopping beta-blockers can help older adults with heart failure with preserved ejection fraction (HFpEF) feel better and function better. This study will test whether "deprescribing" or stopping these medications in a careful, guided way can improve symptoms and quality of life. Participants will be randomly assigned to one of two groups: Deprescribing group: Beta-blockers are gradually reduced using capsules that contain decreasing doses. Usual care group: Beta-blockers are continued at the usual dose in look-alike capsules. All participants will: * Take study medicine for about 4 months * Have their blood pressure and heart rate monitored * Complete regular phone calls and questionnaires about how they are feeling This study does not involve any experimental medication. Participants active involvement in the study will last approximately 4 months. During these 4 months they will have 8 scheduled telephone visits.

Testing the CHAT Program for Patients With Heart Failure

The researchers are studying whether an intervention that involves video-based educational content and a health coach is acceptable, feasible, and effective for people with Heart Failure with Preserved Ejection Fraction (HFpEF).

Can Tiny Bubbles Offer an Alternative to Catheters for Assessing Pressures Inside the Heart? Investigating Ultrasound Contrast Agents as Pressure Sensors Against Gold Standard Catheter Pressures in Cardiac Catheterisation Patients.

The goal of this clinical trial is to investigate if ultrasound contrast agents can be used to estimate filling pressures inside the heart in patients with suspected heart disease. The main questions it aims to answer are: * Is there a strong correlation between the contrast signal and filling pressures inside the heart? * What is the calibration approach to convert the contrast signal from dB to a measure of pressure in mmHg? Researchers will compare the contrast signal with reference pressures measured using a catheter to see if it can be used to quantify filling pressures inside the heart. Participants will: * Be exposed to a small amount of additional ionising radiation to guide a catheter in position inside the heart for reference pressures * Receive an ultrasound contrast agent at the clinically recommended dose and in line with clinical guidelines, via an intravenous line in their arm * Undergo contrast echocardiography - ultrasound scan of their heart with contrast * Undergo standard echocardiography - ultrasound scan of their heart without contrast

Study of JK07 in Patients With Heart Failure and WHO Group 2 Combined Post- and Pre-Capillary Pulmonary Hypertension

This is a Phase 2a, open-label, multiple-dose study to assess the safety, tolerability, and efficacy of JK07 in participants 18 to 85 years of age with diagnosed HF and cpcPH. At least 20 and up to approximately 30 participants will be enrolled and receive JK07 high dose in this open-label trial.

HEART Camp Connect -Promoting Exercise in Adults With Heart Failure With Preserved Ejection Fraction

The goal of this study is to learn more about patients with heart failure with preserved ejection fraction (HFpEF) and exercise. Investigators want to see if meeting with a coach in person or by video conference will help these patients exercise, feel better, and change markers in their blood. Participants will be randomly placed in one of three groups for 18 months. All groups will have access to a fitness center and be given a watch and heart rate monitor to wear during exercise. The usual care group (control group) will have access to exercise videos via the medical fitness center and will not meet with a coach. The HEART Camp group will exercise and meet with their coach in-person at the medical fitness center. The HEART Camp Connect group will have access to exercise videos via the medical fitness center and will meet with their coach via videoconferencing. All participants will take part in an exercise test and study training prior to being randomized. At four data collection time points, participants will wear an activity monitor for 7 days each, have their blood drawn, and answer questions related to heart failure and exercise. Participants will also wear a heart rate monitor when they exercise and fill out a daily exercise diary.

AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure

The investigators analyze the impact of exercise and ablation in patients with symptomatic short-persistent atrial fibrillation (Afib) and heart failure with preserved ejection fraction (HFpEF). It is hypothesized that the combination of ablation and exercise better improves peak oxygen consumption (VO2peak) through improvement of peripheral (exercise training) and central (ablation) adaptations. Exercise intervention will contain a 12-week combined, video-based, supervised, endurance, resistance and respiratory training.

Tailored Exercise Training Study Among Adults With HFpEF

Heart failure with preserved ejection fraction (HFpEF) is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. Exercise intolerance (EI) is the cardinal symptom of HFpEF, which manifests as dyspnea and fatigue. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers. This study will investigate the effects of a remote exercise training intervention on exercise capacity and skeletal muscle composition in patients with HFpEF, or those at risk for it. In addition, it will compare four different lifestyle interventions for their effects on exercise capacity.

US Benchmarking Clinical Study

The goal of this observational study is to measure shear wave velocity (SWV) in patients with non-reduced left ventricular ejection fraction (LVEF) heart failure and left ventricular hypertrophy, with or without transthyretin amyloidosis with cardiomyopathy (ATTR-CM), and in control subjects without heart failure or cardiomyopathy. The main question it aims to answer is: • Can SWV be used to measure myocardial and liver stiffness in the study's target populations? Researchers will compare patients with ATTR-CM, patients without ATTR-CM, and a control group to determine the distributions of SWV in each population. Participants will: * Have a standard cardiology assessment, including a physical exam, blood work, and an echocardiogram. * Undergo an investigational assessment with the eMyosound LYRA device to measure SWV in their myocardium and liver. * Have the investigational assessment repeated by a second observer to assess measurement reliability.

CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation

The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 6 months affects pulmonary capillary wedge pressure (PCWP) at rest and during exercise in adults with failing Fontan circulation.

MOVE-HF MOtivating Physical Activity With BehaVioral Economics in Heart Failure With Preserved Ejection Fraction

This is a three-arm, randomized, controlled trial to test the effectiveness of gamification plus a social incentive - either social support or competition - to increase adherence to physical activity among individuals with HFpEF. There will be a 2-week run-in period to obtain baseline measures of physical activity, followed by a 6-month intervention period and then a 3-month follow-up period.

The Safety and Efficacy of Pulsed Field Ablation for Patients With Persistent Atrial Fibrillation Comorbid With HFpEF.

The goal of this clinical trial is to evaluate the the mid- and long-term clinical efficacy and safety of pulsed field catheter ablation for patients with persistent atrial fibrillation and HFpEF. The main questions it aims to answer are: * What are the differences between the effects of pulsed field ablation and drug therapy? * Which risk factors affecting the outcome of atrial fibrillation ablation, postoperative recurrence, and improvement of cardiac function? Researchers will compare pulsed field ablation to drug therapy to provide some theoretical basis and clinical evidence for the treatment strategy of patients with atrial fibrillation and HFpEF. This study selected patients with persistent AF and HFpEF and divided them into a drug group (treated with class I or class III antiarrhythmic drugs) and a surgical group (Medtronic Pulse Select pulsed field ablation).

Serum IGF1 on Female HFpEF Patients

Study Title: Application of Serum IGF1 in the Diagnosis of Female Heart Failure with Preserved Ejection Fraction (HFpEF) Study Institution: Hong Kong University-Shenzhen Hospital Principal Investigator: Sidong Cai 1. Study Purpose This study aims to investigate whether serum insulin-like growth factor 1 (IGF1) can be used to improve the diagnosis of heart failure with preserved ejection fraction (HFpEF) in women, providing preliminary insights for early detection of this condition in female patients. 2. Study Procedures Information Collection: Relevant medical information will be collected during your outpatient visit or hospitalization. Subject Identification: If you agree to participate, you will be assigned a unique study number to establish a medical record file. Blood Sampling: Blood samples will be collected concurrently with routine clinical blood draws (no additional needle insertions). Volume: 10-20 mL of venous blood each time, collected on the enrollment day, 3 months, 6 months, and 12 months after enrollment. Use of Samples: Samples will be used exclusively for this study. Follow-up Examinations: Standard HF follow-up tests (e.g., echocardiograms) will be conducted as clinically necessary. These are part of routine HF management and will not impose extra burden on you. 3. Risks and Discomforts Confidentiality: All information will be kept strictly confidential. Minimal Risks: Temporary pain, bruising, or tenderness at the blood draw site. Rarely, mild dizziness or (extremely rarely) needle site infection. 4. Responsibilities as a Research Subject You are required to: Provide truthful information about your medical history and current health status. Report any discomfort experienced during the study to the research doctor. Avoid taking restricted medications or foods as instructed. Disclose if you are currently participating in, or have recently participated in, other research studies. 5. Privacy Protection Anonymization: Blood samples will be labeled with your study number, not your name. Confidentiality: Identifiable information will not be disclosed to anyone outside the research team without your permission. Research staff and the sponsor are obligated to maintain your privacy. Records will be stored in locked cabinets and accessible only to authorized researchers. Regulatory agencies or ethics committees may review your data (anonymized) to ensure study compliance. No personal identifying information will be disclosed in study publications. 6. Compensation for Study-Related Injuries In the event of a study-related injury, you are entitled to compensation in accordance with Chinese law. 7. Voluntary Participation and Withdrawal You may refuse to participate or withdraw from the study at any time. Withdrawal will not affect your medical care or rights. Data collected before withdrawal will be excluded from the study results upon your request. The researcher may terminate your participation if you fail to follow the protocol, require other treatments, experience study-related injuries, or for other medical reasons. 8. Contact Information For questions about the study, your rights, or any discomfort/injury during the study, please contact Principal Investigator: Dr. Sidong Cai via caisd@hku-szh.org.

Colchicine in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction

Heart failure with preserved left ventricular ejection fraction (HFpEF) is a syndrome associated with high morbidity and mortality rates. Systemic low-grade inflammation is acknowledged to be a fundamental pathophysiological mechanism of HFpEF. Interventions targeting inflammatory pathway is understudied in HFpEF. Colchicine is a safe and well tolerated anti-inflammatory drug, which interferes with several steps in the inflammatory process. The drug has been extensively studied in different cardiovascular pathologies except HFpEF. We assume that colchicine decreases inflammation and reduces sST2 levels in HFpEF.

Heart Failure in Patients With Diabetes: Cells, Crosstalk and Consequences

This will be an observational study to explore differences in pathophysiology between groups of people with and without heart failure (HF) (reduced and preserved ejection fraction) and with and without diabetes mellitus (DM) with a particular focus on cross-talk (fat, muscle, vascular tissue and the heart). The investigators will invite 600 people to partcipate (100 with HFrEF+DM, 100 with HFpEF+DM, 100 with HFpEF-DM, 100 with HFrEF-DM, 100 with DM, 100 without either HR or DM). Special heart scans, exercise testing, blood testing, testing of the automatic nervous system will be performed and in some, samples of fat and muscle and endothelial cells will be collected. These data will be used to create a cohort of well phenotyped patients with a variety of comprehensively collected clinical information, a cell atlas, and a comprehensive assessment of metabolomics, proeomics and cross-talk in between tissues, allowing comparisons between each group.

Role of Colchicine as Anti-Inflammatory Therapy in HFpEF

Heart failure with preserved ejection fraction (HFpEF) is a condition associated with high morbidity and mortality. Chronic low-grade inflammation plays a key role in its progression, yet few treatments specifically target this pathway. This clinical trial aims to evaluate the effectiveness of colchicine, a well-tolerated anti-inflammatory drug, in reducing inflammation in HFpEF patients. The study will assess whether colchicine lowers levels of soluble ST2 (sST2), a biomarker linked to inflammation and cardiac stress in HFpEF. Participants will take colchicine daily for three months, with blood samples collected at baseline and at the end of the study to measure changes in sST2 levels. The findings could provide new insights into the potential role of colchicine as a treatment for HFpEF.

AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor

This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF) severity categories based on the American Society of Echocardiography's (ASE) 4-category scale. The software analyzes continuous ECG waveform data acquired by the FDA-cleared Peerbridge COR® ECG Wearable Monitor, an ambulatory patch device designed for use during daily activities. The AI software assists clinicians in cardiac evaluations by estimating EF severity, which reflects how well the heart pumps blood. In this study, EF severity determination will be made using 5-minute ECG recordings collected during a 15-minute resting period with participants seated upright. The results will be compared to EF severity obtained from an FDA-cleared, non-contrast transthoracic echocardiogram (TTE) predicate device. This comparison aims to validate the accuracy of the AI software.

The Gut Microbiota and Metabolites in HFpEF

Heart failure (HF) with preserved ejection fraction (HFpEF) has emerged as a critical public health concern. The annual mortality rate for HFpEF is approximately 15%, accompanied by a re-hospitalization rate of nearly 80%. Survival rates over a 5-year period typically range from 25% to 50%. Existing medications effective against HF with reduced ejection fraction (HFrEF) have shown no significant effect on HFpEF. Only the sodium-glucose cotransporter 2 inhibitor (SGLT2i) has demonstrated significant improvements in patient survival and re-hospitalization rates, thus earning a Class IA recommendation in clinical guidelines. HFpEF is characterized as a complex, heterogeneous, multi-organ systemic syndrome primarily associated with risk factors such as advanced age, obesity, metabolic syndrome, type 2 diabetes mellitus (T2DM), hypertension, sedentary lifestyle, coronary atrial disease (CAD), and kidney disease. Therefore, it is crucial to investigate other multi-system disorders closely associated with cardiac diastolic dysfunction to gain a comprehensive understanding of the underlying mechanisms of HFpEF. The human digestive tract harbors a complex and dynamic microbial community known as the gut microbiota, which comprises up to 100 trillion microorganisms and approximately 150 times more genomes than the human genome, often referred to as the "second genome" of the human body. Recent years have seen growing recognition and extensive research into the role of gut microbiota in the pathogenesis and development of cardiovascular diseases. In HFrEF patients, there is a significant decrease in the diversity of gut microbiota, along with changes in its composition and structure. Notably, pathogenic bacteria such as Campylobacter and Candida species exhibit a substantial increase correlating with disease severity, while anti-inflammatory bacteria like Brauteria demonstrate a marked decrease. Furthermore, gut microbiota can influence the host's cardiometabolic traits through the modulation of both its own and host-produced metabolites. HFpEF is increasingly considered a metabolic disease. Comorbidities associated with HFpEF, including obesity, T2DM, metabolic syndrome, hypertension, and coronary artery disease (CAD), have been reported to be closely related to gut microbiota. However, the relationship between gut microbiota and HFpEF is still not fully understood. A recent study indicates that indole-3-propionic acid (IPA) could attenuate diastolic and metabolic dysfunction and mitigate gut microbiota dysbiosis in an HFpEF mouse model. Several clinical studies have noted alterations in microbial metabolites such as short-chain fatty acids (SCFAs), and trimethylamine N-oxide (TMAO) in HFpEF patients. It is now well recognized that targeting the gut microbiome and its metabolites represents a promising novel therapeutic strategy for managing cardiovascular diseases. Therefore, this study is to investigate the changes and function of gut microbiota and metabolites in HFpEF.

Exercise Magnetic Resonance Imaging in Patients With Obesity Associated Heart Failure

To aim of the EXPOSURE study is to investigate the effects of epicardial fat on cardiac function, pericardial constraint and pulmonary artery vasodilatation using cardiac magnetic resonance (CMR) imaging at rest and during exercise stress testing in patients with HFpEF.

Validation of a Machine Learning Predictive Model to Distinguish Post-capillary Pulmonary Hypertension

In this study the diagnostic accuracy of a diagnostic tool for the diagnosis of post-capillary pulmonary hypertension will be investigated. The diagnostic tool was designed based on artificial intelligence, using machine learning on a database of 344 patients with group 1 or group 2 pulmonary hypertension. The tool uses 20 non-invasive parameters which are derived from laboratory results, ECG, echocardiography and spirometry. Based on these parameters, the predictive tool estimates the probability of group 2 pulmonary hypertension. During this clinical study, patients with an intermediate or high suspicion of pulmonary hypertension, with an indication for a diagnostic right heart catheterization, will be included. Patients with risk factors for group 3, 4 or 5 pulmonary hypertension will be excluded. The necessary parameters to run the predictive model will be extracted from the patients medical file. Patients will undergo a standard of care right heart catheterization (gold standard). Afterwards the results of the predictive model will be compared to those of the right heart catheterization, to allow the assessment of the sensitivity, specificity, positive and negative predictive value of the predictive tool.

Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)

To investigate whether RFCA is superior to AADs in AF patients with HFpEF on the basis of optimized anti-heart-failure drug therapy regarding their longterm clinical outcomes.