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Showing 1-16 of 16 trials
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).
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.
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.
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.
NCT06862908
This is a multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of IBI362 in Chinese subjects with heart failure with ejection fraction retention/mild ejection fraction reduction (HFpEF/HFmrEF) combined with obesity (BMI≥28kg/㎡). This study will enroll about 141 NYHA Class II-III HFpEF/HFmrEF subjects combined with obesity. Eligible participants will be randomly assigned to IBI362 4 mg, IBI362 6 mg, or placebo at a ratio of 1:1:1, randomized by concomitant atrial fibrillation during screening (history/screening ECG). The trial period includes a 2-week screening period, a 52-week double-blind treatment period, and a 4-week safety follow-up period.
NCT07022379
The goal of this observational study was to evaluate trends and determinants of SGLT2 inhibitor (SGLT2i) prescriptions in heart failure patients from 2021 to 2024, particularly in relation to LVEF subgroups and evolving scientific evidence (EMPEROR-Preserved, DELIVER, 2023 Guidelines). Participant population were adults with heart failure using the Satelia®Cardio web application to remotely monitor their condition. The main questions it aims to answer are: * to compare the prescription of treatments (including doses, and distribution of patients according to various therapeutic classes recommend for heart failure) with ESC recommendations to see to what extent GDMTs are adhered to. * to quantify the association between the presence of treatments and the risk of alerts/hospitalizations and overall death and as a function of LVEF using telemonitoring. * to evaluate the adherence across patient profiles and cardiologist practices (outpatient vs. hospital-based). Participants will complete follow-up, quality-of-life and patient support questionnaires and provide data regarding their treatments on the web application.
NCT06768437
In this study the investigators are aiming to recruit 130 patients with heart failure with preserved ejection fraction who are obese and non-obese to undergo CT and MRI scans, as well as some other investigations including blood tests, to help investigate if having more fat around the heart leads to worse heart function in this condition. This may lead to the development of new treatments aimed at lowering fat levels around the heart and in the rest of the body, specifically to treat HFpEF.
NCT06826963
This study is designed to evaluate the safety, feasibility, and effectiveness of a 12-week eccentric exercise program for older adults with sarcopenia (muscle loss) or sarcopenic obesity and chronic heart failure (HF). The program aims to improve physical performance, muscle strength, and overall health without causing excessive strain on participants. Eccentric exercise has shown potential benefits for improving muscle function, and this study will help determine if it is a safe and effective option for individuals with heart failure and muscle loss. Study Goals: The primary aim of this study is to test the feasibility and effectiveness of an eccentric exercise program for older adults with sarcopenia and CHF. The study will monitor physical performance, adherence to the program, and participants' ability to tolerate the exercise, as well as any impact on heart and muscle health. Study Population: A screening visit will be scheduled to determine if individuals meet the criteria to participate in the study. During this visit, a detailed assessment will be made, and if eligible, participants will sign an informed consent form. This study will assess whether a 12-week eccentric exercise program can help improve muscle strength, cardiovascular health, and overall physical performance in individuals with HF and sarcopenia. The program will involve exercising on an eccentric bike, which is designed to reduce strain on the heart while providing effective muscle strengthening benefits. The study will use several physical performance tests to assess the impact of the exercise program, including: 1. Short Physical Performance Battery (SPPB): Evaluates mobility and strength. 2. 6-Minute Walk Test (6MWT): Measures cardiovascular fitness. 3. Handgrip Strength and Leg Strength Tests: Assess upper and lower body muscle strength. 4. Additionally, body composition will be evaluated using tools such as DXA scans and bioelectrical impedance analysis (BIA) to measure muscle mass, fat, and overall health status. The program's adherence and tolerance will be carefully monitored by measuring session completion, intensity, and participant feedback. Primary Outcomes Feasibility Measures: 1. Recruitment and Completion Rate: The ratio of participants recruited to those who successfully complete the study, including post-intervention assessments. 2. Session Attendance: The number of training sessions attended out of the total planned sessions. 3. Adherence to Training Volume: The number of prescribed exercises completed by participants compared to the total planned. 4. Program Tolerance: Evaluated by comparing the Rate of Perceived Exertion (RPE) during sessions to the target RPE. To be considered feasible, the study must meet these criteria: Recruitment \>50%, Follow-up loss \<20%, Median attendance at training sessions \>80%, Median adherence to prescribed volume \>75%, Tolerance to RPE \>70%. Secondary Outcomes Effectiveness Measures: 1. SARC-F: A tool for identifying individuals at risk of sarcopenia, based on self-reported issues like weakness and difficulty walking. 2. Mini Nutritional Assessment (MNA): Evaluates nutritional status to rule out malnutrition, which could affect training outcomes. 3. Mini Mental State Examination (MMSE): Assesses cognitive function. 4. Minnesota Living with Heart Failure Questionnaire: Evaluates how heart failure affects daily life. 5. International Physical Activity Questionnaire (IPAQ): Measures physical activity levels at baseline. In addition to the physical performance tests mentioned, the study will assess muscle mass and fat distribution using DXA scans and BIA, providing a comprehensive view of body composition. Finally, the feasibility of remotely monitoring patients' physical activity to determine the impact of the intervention on their daily lives, specifically in terms of mobility and autonomy is assessed. To this end, patients will be asked to wear a set of five sensors (two on the ankles, two on the wrists, and one on the waist) for at least four days. The Axivity AX6 sensors, chosen for their light weight and long battery life, will collect data used to monitor time spent moving, sitting, and lying down, as well as to assess the quality of the recorded movements.
NCT06685237
Heart failure with preserved ejection fraction (HFpEF) has grown to become the dominant form of heart failure (HF) worldwide, in tandem with ageing of the general population and the increasing prevalence of obesity, diabetes mellitus and hypertension. In 2020, \> 70% of patients with heart failure had preserved ejection fraction. The incidence and prevalence of HFpEF has been growing by 10% every 10 years relative to HF with reduced ejection fraction (HFrEF). In 2017, the prevalence of HFpEF varied from 1% to 14% based on available data from Europe and USA. HFpEF is associated with high morbidity and mortality, and patients with HFpEF have similarly high hospitalization rates as patients with HFrEF. Hence, HFpEF poses a substantial global health challenge. Despite its prevalence, HFpEF remains undiagnosed and underrecognized, necessitating a comprehensive approach to both identification and management. Ensuring successful treatment necessitates early identification of HFpEF. Consequently, a targeted screening strategy has been devised for the identification of HFpEF patients. Given the higher prevalence of heart failure (HF) in the elderly population, testing the screening strategy is imperative to customize it to the specific needs of vulnerable patients who may be more inclined to decline participation in the screening program.
NCT06604611
The main purpose of the CHIPS trial is to evaluate the efficacy and safety of colchicine in heart failure with preserved ejection fraction (HFpEF) patients with inflammation, including the effects of colchicine on circulating inflammatory markers, cardiac structure, cardiac function, clinical symptoms and exercise capacity in HFpEF patients.
NCT06036186
This study is a prospective, double blind, self-controlled, randomized, cross-over study to evaluate the feasibility, efficacy, and safety of treating patients with Heart Failure with preserved Ejection Fraction (HFpEF) associated with hypertension using the PressurePace™ system of Right Atrial Pacing regulated by blood pressure in subjects with dual chamber pacemakers. The objective of this study is to show that blood pressure-controlled right atrial pacing improves exercise tolerance, improves heart failure symptoms, and improves hypertension control in subjects with HFpEF associated with hypertension compared to conventional bradycardia pacing alone.
NCT04327024
International, Multicenter, Double-Blind, Placebo and Active Control Efficacy and Safety Study to Evaluate Verinurad combined with Allopurinol in Heart Failure with Preserved Ejection Fraction
NCT04232345
This study is randomized, single-blind, placebo-controlled Phase 1 study aimed to assess the safety and efficacy, pharmacokinetics and pharmacodynamics of multiple doses of oral AZD4831 in healthy Japanese and Chinese volunteers