320 Clinical Trials for Congestive Heart Failure
The goal of this clinical trial is to learn if drug atibuclimab (IC14) works to treat adults hospitalized with acute decompensated heart failure (ADHF). It will also learn about the safety of IC14. The main questions it aims to answer are: Is the drug IC14 safe in patients with ADHF? What are the IC14 drug levels in the bloodstream after treatment with IC14? What is the impact of IC14 treatment on markers of disease in the bloodstream? What is the impact of IC14 treatment on measures of heart failure? There is no placebo arm in this study. Participants will: Take drug IC14 once via an intravenous infusion After the infusion, be visited in the hospital or visit the clinic 5 times for checkups and tests Answer questions about their medical status via a phone call 3 months after the infusion
Congestive heart failure (CHF) occurs when the heart is weak and not able to effectively pump blood to the body. One of the common manifestations of CHF is fluid overload and swelling of the legs. Diuretics or "water pills" are usually the treatment for fluid overload and leg swelling; however, in some patients' diuretics are no longer effective or the effectiveness is limited due to poor kidney function. The presence of chronic swelling of the legs could potentially damage the veins; additionally, it could lead to chronic skin changes in the legs and in the worst cases to a leg ulcer. Compression stockings are used in patients with venous diseases to reduce the swelling of the legs and improve mobility and quality of life. Although, there is a theoretical risk that compression stockings might push the fluid of the legs back to the heart and lungs worsening the CHF. The purpose of this study is to determine whether the use of knee-high tight socks (tight stockings with strong compression) vs. knee-high soft socks (soft stockings with minimum compression) are effective in preventing swelling and skin changes and safe in patients with CHF. During the first visit (in-person) a routine medical test will be performed including blood tests, review of the medication doses, current weight, an ultrasound images of the veins, (venous reflux ultrasound), questions about health status and a brief physical exam. The participants will be randomly assigned to receive tight compression vs. soft compression socks. Participants will be asked to wear the socks at least 8 hours a day for 5 days a week. There will be a total of 3 virtual visit (by video or telephone); the first one after one week, then after one month and two months. During the virtual visit participants will be asked about symptoms, current medications and doses, and current weight. The participants are expected to return to the clinic after 3 months for a second in-person visit. During this visit the investigators will ask questions about participant's health, they will perform a brief physical exam of their legs, and check participants weight and medicines; also, a venous ultrasound of the legs, questions about health status will be performed. The duration of the study is 3 months.
This research study is being done to compare the effectiveness two drugs: an extended release torsemide (ERT) versus generic immediate release Torsemide (IRT) in reducing the worsening of symptoms of Overactive Bladder (OAB i.e., frequency, urgency, or urgency incontinence) in patients with chronic congestive heart failure (CHF). This study will include CHF patients who experience worsening OAB) symptoms with use of a loop diuretic. The total duration of the study is about eight weeks with a total of nine visits. There will be a screening visit that lasts one to two hours. The screening visit includes history and physical exams, blood draws, and urine analysis. If eligible for the study, participants will receive either generic torsemide or extended release torsemide for the first four weeks. Participants will do a virtual research visit on week one, two and three to submit a symptom diary and answer a questionnaire about urinary symptoms. At four weeks, history and physician exam will be done and blood will be collected. Participants will be assigned to receive either extended release torsemide (if they initially received generic torsemide) and generic torsemide (if they initially received extended release torsemide) for the next four weeks. Participants will attend virtual research visits on week five, six and seven to submit a symptom diary and answer a questionnaire about urinary symptoms. At the end of the study in week eight, they will have history and physical exams and blood draws. Some risks from the study may include side effects of torsemide like acute kidney injury, fluid/electrolyte loss, hypersensitivity reactions and reversible hearing loss/tinnitus.
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.
This is a Phase 2 adaptive, double-blinded, placebo-controlled, randomized, multi-center trial study to evaluate the safety and efficacy of a single dose of AB-1002, administered via antegrade intracoronary artery infusion, in males and females age \>18 years with non-ischemic cardiomyopathy and NYHA Class III symptoms of HF. Subjects will be randomized into one of three treatment groups in a 1:1:1
Heart failure (HF) remains one of the most common causes of hospitalization with high morbidity and mortality, and its worldwide prevalence is increasing. Despite notable progress in outcomes for HF the rate of early rehospitalization for HF (re-HHF) remains high, especially in the first 30 days. The rate of 30-day HF rehospitalization in the claims databases of the USA and in worldwide randomized clinical trials is 20-25% and 5-10% respectively. In patients with bilateral leg edema, the presence of CHF (congestive heart failure) as the factor causing or worsening local leg swelling should be evaluated. Application of local leg compression can be considered in stable CHF patients without decompensated heart function (NYHA Class I and II) for both CHF-related edema treatment and for treatment of concomitant diseases leading to leg swelling occurrence. Current literature does not have recommendations on the routine use of lower limb compression in leg swelling related to end stage heart disease and advanced, decompensated heart failure. Potential benefits of applying medical compression in more severe classes of CHF (NYHA Class III and IV) would need to be evaluated by further randomized clinical studies to determine which cohort of patients would benefit most from lower limb compression, as well as to choose the safest and most efficient compression protocol for these patients. The AIM of this study is to improve the clinical outcome of patients admitted with exacerbation of heart failure with associated volume overload. The primary objectives are: 1) diminish the duration of hospitalization of CHF patients; 2) decrease the incidence of rehospitalization from CHF exacerbation and 3) prevent local complications associated with prolonged lower extremity edema. The investigators hypothesize that the application of local compression to bilateral lower extremities, when added to guideline-based therapy for CHF exacerbation, will improve overall clinical outcome in patients at the University of Texas Medical Branch (UTMB). If our intervention is proven to be beneficial, it could lead to a significant reduction in nationwide hospitalization costs associated with heart failure.
This is a prospective, double-blind, sham-controlled, multicenter, randomized clinical trial is to study the effects of remote ischemic preconditioning on contrast-associated acute kidney injury, functional capacity, and major adverse kidney events in in patients with congestive heart failure undergoing cardiac catheterization and/or percutaneous coronary intervention.
It is believed that targeted SERCA2a enzyme replacement in HFrEF patients will correct defective intracellular Ca2+ hemostasis, resulting in improved cardiac contractile function and energetics which will, in turn, translate to improved clinical outcomes. Additionally, it is hypothesized that correcting SERCA2a dysfunction will also improve coronary blood flow through correction of the impaired endothelium-dependent nitric oxide-mediated vasodilatation observed in heart failure.
The purpose of this study is to investigate whether acute stress can precipitate congestive heart failure (CHF) exacerbation in patients with CHF.
This research trial studies whole exome sequencing in finding causative variants in germline deoxyribonucleic acid (DNA) samples from patients with congestive heart failure receiving therapy for breast cancer. Studying samples of germline DNA in the laboratory from patients with congestive heart failure receiving therapy for breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to congestive heart failure.
The primary objective of this study is to learn whether a morning dose of extended-release torsemide enhances renal sodium excretion after lunch (4-8 hours after dosing) compared to immediate-release torsemide. This is a randomized, double-blind, crossover study in patients with heart failure who are on a stable dose of a loop diuretic. During the study period, participants' current loop diuretics will be replaced with an equivalent dose of either immediate-release or extended-release torsemide. Following a one-week stabilization period on the assigned torsemide formulation, patients will report to the clinical site for an assessment visit. On the study day, patients will take a single dose of the same torsemide formulation they have been on for the past week, administered after breakfast. Urine samples be collected are: * 0-4 hours post-dosing (pre-lunch period) * 4-8 hours post-dosing (post-lunch period) * 8-24 hours post-dosing (24 hours period) The primary endpoint will be urinary sodium excretion (4-8 hours after dosing). This will be compared between the extended-release arm and the immediate-release arm to assess the efficacy of prolonged diuretic action. In addition, urinary potassium and creatinine excretion and creatinine clearance will be measured in all urine samples as the safety endpoints.
This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure. In this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo and empagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between 1 and about 3.5 years. During this time, they can continue their regular treatment for heart failure. Participants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, must go to hospital due to heart failure, or die during the study. The time until these events are observed is compared between the treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
The purpose of this study is to find out if additional images taken during a stress echocardiogram study and risk score calculation will help the doctor determine if shortness of breath or chest pain are caused by stiff heart (heart failure with preserved ejection fraction or HFpEF).
The purpose of this early feasibility study is to evaluate the safety and feasibility of the device for percutaneous shunting of the interatrial septum and improvement of heart failure related symptoms. The primary goal is to determine if the device is safe to use. The findings from this study may be used to refine the intended patient population, the design of the device, or develop a subsequent randomized study.
To work best, clinical decision support tools (CDS) must be timed to provide support when healthcare decisions are made, which includes virtual visits (phone or video). Unfortunately, most CDS tools are either missing from virtual visits or not designed for the unique context of virtual visits (e.g., availability of physical assessments and labs, different workflows), which could generate new inequities for patients more likely to use virtual visits. The objective of this study is to test the reach, feasibility and acceptability of a new CDS tool for heart failure with reduced ejection fraction (HFrEF) during virtual visits. This new CDS tool was developed through an iterative design process, and will be compared to an existing HFrEF CDS tool in a randomized pilot study at outpatient cardiology clinics throughout the UCHealth system.
Recent medical guidelines for the management of heart failure (HF) have established a combination of specific classes of medications as the best treatment for patients with heart failure with reduced ejection fraction (HFrEF). However, studies have shown that these medications, known together as guideline-directed medical therapy (GDMT), are not being used in clinical practice less often than they could be. Several tools to promote broader use of these treatments (including patient checklists) have shown promise for increasing use of GDMT. However, these tools have not been broadly implemented within large health systems. The goal of this study is to see if using these tools broadly within cardiology clinics will increase the use of GDMT. This study is important because it could help improve the use of GDMT, which may lead to improved patient care and outcomes.
This clinical trial investigates the safety and preliminary effectiveness of YAP101, a gene therapy designed to improve heart function in adults with ischemic heart failure and reduced ejection fraction (HFrEF). Ischemic heart failure, often resulting from a prior heart attack, leads to poor heart function and quality of life. Current treatments are limited, and there is an urgent need for new therapies. YAP101 works by delivering a gene therapy using a specialized vector to heart cells, targeting a pathway involved in heart repair. By temporarily activating heart muscle regeneration, YAP101 aims to restore damaged tissue, reduce scarring, and improve the heart's pumping ability. The study will enroll participants who will receive a one-time dose of YAP101 via a minimally invasive cardiac injection. Researchers will monitor participants over 12 months to assess safety and changes in heart function, exercise tolerance, and quality of life.
The goal of this clinical trial is to explore the impact that an at-home cardio-oncology rehabilitation (CORE) may have on short-term cardiovascular fitness and psychosocial wellness in pediatric cancer survivors. The main question it aims to answer are * To evaluate the efficacy of an at-home CORE model on short-term cardiovascular fitness and psychosocial wellbeing in adolescent cancer survivors. * To evaluate the exercise adherence rate among adolescents at risk for heart failure and assess barriers to compliance. * To explore which specific CORE resources are of most value to patients in creating sustainable healthy lifestyle modifications. * Hypothesis: Pediatric cancer survivors who implement exercise and dietary recommendations will demonstrate improvement in cardiovascular fitness and general wellness. A multidisciplinary team approach can facilitate adherence to a moderately rigorous exercise prescription, and thus enhance the health benefits of a CORE program at CHLA. Participants will undergo cardiovascular studies and a quality-of-life survey prior to exercise intervention, and at the end of the 6-month study period.
This observational study is being done to learn more about heart attack recovery in patients supported with the Impella 5.5 left ventricular assist device (LVAD) as part of their standard of care. There are three stages in this study: screening, treatment and post treatment. There will be two phases of enrollment: First phase will enroll 10 patients; second phase will enroll an additional 40 patients. Approximately 50 participants will take part in the study at Columbia University Irving Medical Center. Participation in this research is expected to last approximately 14 months. This time estimate includes a screening period for about 1- 3 days, treatment period of 40 days and post treatment follow-up period for 1 year. Data will be collected through 1- year after heart transplant. Clinical data (medical history, vital signs, laboratory assessments) from medical records, to perform functional and neurocognitive testing, and to obtain blood and discarded heart tissue from for the purpose of this research study. Participants will be asked to share their records for echocardiography, right heart catheterization, laboratory data and clinical information. Participants are required to complete an assessment a 6-minute walk, hand grip strength test and questionnaire to evaluate neurocognitive status.
The aim of this mixed methods randomized controlled trial is to test the integrated nurse-led intervention bundle for family home care management of end-stage heart failure and palliative care in rural Appalachia. This intervention bundle is designed to address rural disparities in access to health care, with the help of the faith-based nurses and local volunteer visiting neighbors.
This retrospective, non-randomized cohort study will evaluate how well the Cordella PA Sensor System works compared to standard medication treatment in people with chronic heart failure. The study will track patients for two years to see if those using the Cordella system have fewer deaths and hospitalizations related to heart failure.
The purpose of this study is to determine if transseptal extra-corporeal membrane oxygenation (ECMO) can bridge pulmonary hypertension- right heart failure (PH-RVF) patients to lung transplant safely.
The ENGAGE-HF mobile application tracks three key features over time: (1) heart failure health status, (2) vital signs (e.g., blood pressure, heart rate) and weight, and (3) the quality of heart failure medication therapy. Helping patients understand how these characteristics interact and change over time may improve their ability to understand and manage heart failure. In this study, the investigators aim to evaluate whether the ENGAGE-HF mobile application, by facilitating the behavior change strategies of self-monitoring and feedback, and a clinician-facing dashboard, improves the optimization of heart failure guideline-directed medical therapies (GDMT) and quality of life. An optional sub-study of cognitive function will invite all eligible participants enrolled in the main study to participate.
The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction.
Heart failure (HF) affects more than 6 million adults in the U.S. alone, with increasing prevalence. Cardiovascular congestion with resultant limitation in physical activity is the hallmark of chronic and decompensated HF. The current HF physiologic model suggests that congestion is the result of volume retention and, therefore, therapies (such as diuretics) have generally been targeted at volume overload. Yet therapeutic approaches to reduce congestion have failed to show significant benefit on clinical outcomes, potentially due to an untargeted approach of decongestive therapies. The investigators' preliminary work suggested a complimentary contribution of volume redistribution to the mechanism of cardiac decompensation. The investigators identified the splanchnic nerves as a potential therapeutic target and showed that short-term interruption of the splanchnic nerve signaling could have favorable effects on cardiovascular hemodynamics and symptoms. As part of the investigators' proposal, the investigators will test the safety and efficacy of prolonged splanchnic nerve block in a randomized, controlled, blinded study in patients with HF and reduced ejection fraction (HFrEF). The results will help test the hypothesis of volume redistribution as a driver of cardiovascular congestion and functional limitations and pave the way for splanchnic nerve blockade as a novel therapeutic approach to HF.
The TEAM-MGH study will formerly evaluate impact of the GDMT Clinic versus matched usual care patients on the proportion of GDMT administration over a 12 week period in approximately 300 total patients with HF across the spectrum of LVEF (with a minimum of 150 with HFrEF). The study will also assess impact of the GDMT Clinic on health status, functional capacity, biomarker profiles, cardiac remodeling and cardiovascular events.
Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF. The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1. Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation. Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD. In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.
The overarching goal of this research proposal is to study the feasibility and clinical impact of implementing an Inova system-wide heart failure treatment algorithm for patients with symptomatic heart failure due to reduced left ventricular ejection fraction (HFreF) and secondary MR Aim is to check the effectiveness of the IHFTA in identifying patients who are most likely to benefit from percutaneous transcatheter Mitraclip repair in real world
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.
To describe and compare the symptom burden in cancer patients with concurrent diagnosis of heart failure (HFrEF compared to HFpEF).