Active clinical trials for "Heart Failure"

The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has impact on patient's lives, change of kidney function, and how well finerenone treatment is tolerated. The study plans to enroll 6000 male and female patients of the age of 40 years and above suffering from heart failure with ejection fraction greater than or equal to 40%. Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg once daily. Study duration will be up to 43 months.

Heart failure is a devastating disease with great impact on the quality of life and survival of those who suffer from it. The disease has a high prevalence and its treatment represents high economic costs for health systems. In Colombia, cardiovascular diseases that are part of chronic noncommunicable diseases are the first cause of death. According to figures from the World Health Organization (WHO) in 2014, 28% of deaths in the country were due to cardiovascular diseases. Pharmacological treatment, patient education and regular physical activity are the cornerstones for the treatment of heart failure and therefore the international clinical practice guidelines as well as the guide of the Colombian Ministry of Health recommend the performance of supervised physical exercise for patients with the disease. Cardiac rehabilitation programs using regular and supervised aerobic exercise positively impact the lives of these patients by improving functional capacity, quality of life, psychological well-being and can have an effect on important outcomes. such as hospitalizations and mortality. The Health Rehabilitation Group has carried out several research projects on heart failure and other cardiovascular diseases, and in agreement with the Ministry of Health and Social Protection (COLCIENCIAS) developed the Clinical Practice Guide for the Prevention, Diagnosis, Treatment and Rehabilitation of Heart Failure in population over 18 years of age classification B, C and D. The group's research has demonstrated the efficacy and safety of cardiac rehabilitation to improve functional capacity, abdominal perimeter and systemic blood pressure figures in patients with cardiovascular diseases, improvement in the quality of life in patients with heart failure and the prevalence of musculoskeletal diseases has even been described in this group of patients. In one of the studies, an exercise program was compared with an educational program and it was concluded that the exercise was effective in improving the health-related quality of life of patients with heart failure. Despite the benefits demonstrated by the cardiac rehabilitation programs, the adherence to exercise of the patients is low, especially during phase III of the program in which patients exercise in an unsupervised manner with periodic care follow-up. In some studies they have carried out other types of follow-up such as telephone control, home visits and telemonitoring, but there are no studies that carry out a low-cost program, with telephone follow-up and distance education to improve adherence in the phase III of cardiac rehabilitation. The aim of this study is to determine the effect of an education, follow-up and stimulus program of adherence to the achievements of phase III of the Rehabilitation Program in patients with heart failure, on functional capacity, quality of life, the need to return to phase II of the program and rehospitalizations.

The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional Class II, Class III, or ambulatory Class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.

This is prospective, non-randomized, single-arm, international, multicenter, clinical safety and performance clinical investigation to evaluate the AccuCinch® Ventricular Repair System for the treatment of heart failure, with or without functional mitral regurgitation due to dilated ischemic or non-ischemic cardiomyopathy

The objective of this pilot study is to evaluate the safety and performance of implanting the IASD® System II in Heart Failure patients with reduced ejection fraction and elevated left sided filling pressures, who remain symptomatic despite Guideline Directed Medical Therapy (GDMT).

Heart failure is a chronic disease, being the second cause of death in Brazil. Currently, it is estimated that 6.4 million Brazilians suffer from this disease. The higher number of rehospitalization, lower survival of these individuals. There are recommendations from Societies of Cardiology for the inclusion of effective self-care for patients with chronic HF, intend greater control of symptoms, greater adherence to treatment and, consequently, decrease of rehospitalization. One of the pillars of self-care's education for chronic patients recommended by the Health Ministry is the management of the patient's emotional aspects. These have been undertreated in most studies. The prevalence of depression among patients with HF is high and ranges from 41% to 72%, and the assessment with the BDI-II, which is the gold standard used, is 67%. Patients with HF and depression have greater difficulty in adhering to treatment and poor maintenance of self-care. Also, they present 4 times more risk of rehospitalization/mortality. Faced with this problem, this project was designed, proposing an online psychological support group for patients with heart failure and depression, primarily aimed at improving self-care, adherence and secondarily at reducing the rates of depression and readmission.

The primary objective of this study is to determine if a best practice alert (BPA) system that prompts providers to consider the addition of a mineralocorticoid receptor antagonist (MRA) in eligible patients with heart failure with reduced ejection fraction (HFrEF) will result in increased prescription of this guideline-recommended therapy. The system will also inform providers about FDA-approved potassium binders for the treatment of hyperkalemia if elevated potassium is a barrier for MRA use and will provide educational information on the evidence for MRA therapy in these patients.

The study aim is to determine whether a 12-month digitally delivered behaviour change solution for patients with heart failure improves symptom frequency, mental health, quality of life, medication adherence, and self-care behaviour. The primary and secondary endpoints will be captured at 6- and 12-months follow-up visits to assess longer term effect on outcomes.

The goal of this clinical trial is to evaluate the short-term clinical outcomes of starting Dapagliflozin on the same day of hospital admission in patients with acute decompensated heart failure (ADHF). The main questions it aims to answer are: Does early initiation of Dapagliflozin improve the length of hospital stay and in-hospital mortality in patients with ADHF? Does early initiation of Dapagliflozin enhance the diuretic response, weight reduction and pro-BNP reduction in the acute stage of HF? Does early initiation of Dapagliflozin adversely affect the hemodynamic stability and kidney functions in the acute stage of HF? Participants will be randomized with the ratio of 1:1 within 24 hours of admission to receive Dapagliflozin 10 mg/day versus standard of care. Follow up will continue for 1 month after hospital discharge. Researchers will compare the in-hospital and 30-day clinical outcomes in the Dapagliflozin group versus the standard treatment group.

Rationale: Sodium glucose co transporter 2 (SGLT2) inhibitors are a relatively new class of agents, originally developed as oral antihyperglycemic drugs. SGLT2 inhibitors are clinically available since 2012 for the treatment of patients with diabetes mellitus type 2. Later, SGLT2 inhibitors appeared to have also specific reno- and cardioprotective effects. Remarkably, the trials that have been performed thus far excluded patients with an eGFR below 25 mL/min/1.73m2 at inclusion, prevalent dialysis patients, and kidney transplant recipients. This is unfortunate, because especially these patients are at high risk of reaching kidney failure requiring dialysis, cardiovascular complications and mortality, whereas there are only few proven effective therapies. There is emerging evidence from experimental studies and post hoc-analyses of randomized clinical trials that SGLT2 inhibitors may also be effective in preventing cardiovascular and mortality outcomes in these patients with severe CKD, including patients receiving dialysis or living with a kidney transplant. For instance, subgroup analysis of the DAPA-CKD trial comparing 624 patients with an eGFR<30 to the remainder of the trial population with better kidney function, demonstrated that the efficacy of the SGLT2 inhibitor dapagliflozin in reducing cardiovascular, heart failure and renal outcomes persisted in the population with impaired kidney function. Furthermore, in the DAPA-CKD trial patients continued to use dapagliflozin or placebo when dialysis was initiated. In the subgroup of patients who initiated dialysis, dapagliflozin was associated with a relative risk reduction for mortality of 21%. Finally, in kidney transplant recipients, SGLT2 inhibitors have been shown to be effective in lowering HbA1c, body weight, blood pressure and stabilize kidney function, and these agents were well tolerated and safe. Taken these findings together there is a sound rationale to study the long-term reno- and cardioprotective efficacy and safety of SGLT2 inhibitors in patients with severe CKD. There are two cardiac sub-studies: the cardiac MRI substudy and the echocardiography sub-study. The echocardiography sub-study is referred to as the "SGLT-2-inhibitors to Target Heart Failure in Peritoneal Dialysis" (STOP HF in PD) study. In STOP HF in PD the effect of dapagliflozin on cardiac function will be assessed in a subset of 100 patients treated with peritoneal dialysis.