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NCT04506606
This research in Veterans with heart failure with preserved ejection fraction (HFpEF) will provide new information on the mechanisms determining the patients' exercise intolerance and the efficacy of regular physical activity to improve this shortcoming by alleviating the patients' neurocirculatory abnormalities. Specifically, the investigators will focus on the role of nerves originating in working limb muscles in determining the patients' exercise intolerance and compromised fatigue resistance before and after a chronic exercise intervention. By focusing on a specific mechanism, this project will evaluate the validity of exercise as an alternative treatment strategy with the overall purpose of improving the quality of life of Veterans with HFpEF.
NCT07214376
The goal of this clinical study is to evaluate the safety and efficacy of percutaneous pulmonary artery denervation with the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) associated with left heart disease (LHD). This randomized control trial will compare the investigational device (The Enhancor System) to control (medical therapy.) Participants who will consist of patients with chronic heart failure (HF) who are receiving maximally tolerated guideline-directed medical therapy (GDMT) for left heart failure, are clinically stable, and who have been diagnosed with CpcPH by right heart catheterization (RHC), will be treated with PADN and followed for 3 years.
NCT07057466
This study aims to improve the early detection of undiagnosed heart disease, which causes serious health issues, hospital admissions, and high healthcare costs. Researchers are exploring how artificial intelligence (AI) can analyse routine heart tests, called electrocardiograms (ECGs), to detect heart problems. These tests can be done using both traditional ECG machines and portable, wearable devices like smartwatches, making it easier for people to monitor their heart health at home. While AI has shown promise using past data, this study will involve the collection of ECG data and subsequent testing of its accuracy in real-world settings to ensure it works well for both doctors and patients. The goal is to see if AI can identify conditions like heart muscle weakness, valve issues, and high lung pressure from the ECG data of patients. The researchers will also compare AI's detections with other blood tests commonly used to diagnose heart disease. The AI models that will be used are being tested for research and validation purposes only. They will not be used for clinical decision-making or providing information to influence diagnosis, treatment, or patient care during the study. The AI outputs are not shared with clinicians and will have no impact on the care pathway. This research will demonstrate if AI-powered ECG analysis - whether from traditional or portable devices - can provide a low-cost, non-invasive way to detect heart disease early and improve health assessments.
NCT05371496
The purpose of this research is to find out if an aggressive intervention to lose weight, will improve symptoms in patients with obesity-related cardiomyopathy, which is also known as the obese phenotype of heart failure with preserved ejection fraction (HFpEF).
NCT07093528
To evaluate the effect of CS reducer implantation in patients with HFPEF and CMD on myocardial ischemia, measured by stress myocardial perfusion using cardiovascular magnetic resonance (CMR)
NCT06536309
Cardiac magnetic resonance imaging (MRI) measures of myocardial interstitial fibrosis (MIF) are elevated in heart failure with preserved ejection fraction (HFpEF) patients and associated with poor prognosis. Extracellular volume (ECV) is the most reproducible and best validated cardiac MRI measure of MIF. Sacubitril/valsartan reduces histological MIF in mice and levels of some extracellular matrix regulatory proteins in humans with HFpEF. However, the effect of sacubitril/valsartan on robust measures of MIF in humans is unknown. Demonstrating reductions in ECV with sacubitril/valsartan would clarify the mechanism of this approved medication. Given the borderline reduction in heart failure hospitalizations with sacubitril/valsartan and the heterogeneity of HFpEF pathophysiology, this result would suggest that neprilysin inhibition may particularly benefit HFpEF patients with greater MIF. The investigators propose a proof-of-concept clinical trial to evaluate the effect of neprilysin inhibition (sacubitril/valsartan vs valsartan alone) on cardiac MRI measures of fibrosis (principally ECV) and circulating protein levels.
NCT07219511
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
NCT07417215
Heart failure is the most common cause of death of patients on chronic hemodialysis treatment, and to date there is no effective therapy for the treatment of this comorbidity in this group of patients. The most common form of heart failure in these groups of patients is heart failure with preserved ejection fraction (HFpEF). As a new therapy for heart failure, a new group of drugs called angiotensin receptor and neprilysin inhibitors (ARNI) has been imposed, whose representative is the drug sacubitril/valsartan. The therapy has been shown to be superior to any other therapy to date for the treatment of heart failure with reduced ejection fraction (HFrEF) and has been included in European and American guidelines for the treatment of patients with HFrEF. Since 2022, the drug has been approved in the USA for the treatment of patients with HFpEF, while in Europe it is still not approved for this indication. Currently, the drug is not approved for patients on chronic hemodialysis anywhere in the world, and its effect on this group of patients is unknown. There are very few studies examining the safety and efficacy of sacubitril/valsartan in chronic hemodialysis patients with HFpEF. Precisely because of this, the aim of this study is to determine the effectiveness of this drug in these groups of patients. I will conduct the research as a randomized controlled trial (single blind research) where the subjects will be patients on chronic hemodialysis treatment who have proven HFpEF. HFpEF is proven by the HFA-PEFF scale. The patients will be divided into two groups - the test group and the control group (30 patients in each group). The input variables will be patients on chronic hemodialysis treatment (whose hemodialysis treatment lasts at least one year); patients with heart failure with preserved ejection fraction; height; weight. Output variables will be heart ultrasound parameters and laboratory findings (NTproBNP, hs troponin, aldosterone, renin). The aim of the study is to determine the effect of sacubitril/valsartan on ultrasound parameters and on cardiovascular and other biomarkers in patients on chronic hemodialysis treatment with HFpEF.
NCT07272902
This study is testing two different ways of treating atrial fibrillation (AF) in people who also have heart failure with mildly reduced or preserved heart function. Patients will randomly be assigned to either rhythm control using catheter ablation or rate control using medicines. The pilot phase will determine if a larger study can be successfully carried out to see which approach better improves survival, reduces hospitalizations, and enhances quality of life.
NCT05592275
The main purpose of this study is to assess the efficacy and safety of LY3540378 in adults with worsening heart failure with preserved ejection fraction
NCT05839730
FIRE-HFpEF is a multi-center, prospective, randomized, single-blinded, clinical feasibility study. This study will enroll up to 105 subjects with heart failure with preserved ejection fraction in the United States. Data will be collected to evaluate whether pacing therapies can lead to improvements in exercise capacity and health status of subjects.
NCT06114498
Study Aim is creation of the Hospital Register of patients with heart failure with preserved ejection fraction (HFpEF) for a comprehensive assessment of the influence of gender characteristics, clinical and anamnestic factors, body composition, topical characteristics of congestion, instrumental data and markers of cellular inflammation and stress on immediate and long-term outcomes in patients with acute decompensated heart failure with preserved ejection fraction. During the study it is planned to assess gender, clinical and anamnestic indicators preceding hospitalization of patients in the hospital; characterize the features of comorbid status in the studied group of patient; study the features of drug therapy at the prehospital stage and during hospitalization in the study group of patient; assess adverse hospital outcomes and outcomes 6 months after hospital discharge and identify factors associated with them; assess body composition in patients with acute decompensated heart failure with preserved ejection fraction in obese patients upon admission to the hospital; characterize the severity and topical characteristics of congestion and compare with the phenotypes of acute decompensation of heart failure; asess adverse in-hospital outcomes and outcomes 6 months after hospital discharge and identify factors associated with them; conduct a clinical and instrumental examination of patients diagnosed with compensated and decompensated HFpEF, verified by echocardiography at rest, as well as in patients with HFpEF verified after an additional diastolic stress test with assessment of intracardiac hemodynamic; analyze the serum concentrations of biochemical markers associated with cellular stress in these groups of patients, as well as in the control group of apparently healthy people; conduct an analysis of associations of biomarker levels with clinical characteristics of patients, the presence of comorbid diseases, including obesity, as well as with data from instrumental examination methods; assess the diagnostic capabilities of HFpEF, defined by various criteria, based on the concentration of the new biomarkers The results obtained will allow us to evaluate the characteristics of the course and outcomes of the disease in Moscow patients, depending on the phenotype of acute decompensation of HFpEF, hospitalized in the hospital during the study period. It is expected to identify phenotypes of acute decompensation of HFpEF that affect the duration of hospitalization and the development of adverse outcomes in the hospital and long-term period of the disease.
NCT05064709
The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.
NCT05953831
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study including approximately 130 randomized HF patients with heart failure with mildly reduced or preserved ejection fraction (LVEF ≥45%), to assess efficacy and safety of CDR132L on reverse remodeling. In this study, patients with HFpEF (EF ≥50%) or HFmrEF (LVEF 45-49%) will be included.
NCT07324772
Atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF) are very common conditions that often occur together and result in worsening symptoms and reduced quality of life (QoL). Limitations being able to participate in activities of daily living is a primary complaint for AF-HFpEF patients, yet effective strategies to address this issue remain limited. While exercise interventions targeting aerobic training (AT) are recommended for patients with AF and HFpEF, unique challenges exist in this patient population who tend to be older. Specifically, many older patients with AF and HFpEF have muscle weakness, sarcopenia and frailty, that can make aerobic-focused exercise difficult and less tolerable. This study proposes that starting with progressive resistance training (PRT) before aerobic exercise may overcome these issues by improving muscle strength, making AT more manageable, and leading to better health outcomes. The goal of this study is to assess whether a sequential exercise program, named 'PREACTIVE' improves how people feel, decrease the amount of symptoms, and their ability to participate in exercise and activities. This study will specifically test a sequenced exercise approach of resistance training followed by aerobic exercise to improve symptoms, and quality of life in AF-HFpEF.
NCT04916470
This study will look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight. This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms. Participants will either get semaglutide or "dummy" medicine, which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm. During the study participants will have talks with the study staff about healthy lifestyle and physical activity. The study will last for about 59 weeks, that is a little more than 1 year. Participants will have 12 clinic visits with the study doctor. * At 6 of the visits participants will have blood samples taken. * At 5 of the visits participants will be asked to fill in a questionnaire * At 4 of the visits participants will have to do a 6-minute walking test * At 3 of the visits participants will have a test to check the heart. * participants will have their eyes checked before or at the start of the study and at the end of the study Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
NCT07223242
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.
NCT06338839
A multicenter observational retrospective-prospective study of prevalence and clinical characteristics of transthyretin amyloidosis (ATTR) cardiomyopathy (CM) in Russian patients with heart failure with preserved ejection fraction (HFpEF) in real clinical practice. The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who are participating/participated in the PRIORITY-CHF study and have HFpEF. Those patients who have a high suspicion of having ATTR-CM and provided informed consent will be invited to participate in the prospective phase. The prospective phase will consist of three visits, during which a routine comprehensive cardiologic evaluation in order to confirm or exclude ATTR-CM diagnosis will be performed. In patients with confirmed ATTR-CM the material for genetic testing will be collected in order to specify the type of ATTR-amyloidosis
NCT06369298
This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure. There will be 2 cohorts in this study: Cohort 1: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) of ≤ 40%. Cohort 2: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) \> 40% and ≤ 65%.
NCT04847557
The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.