Active clinical trials for "Heart Failure"

Background: Acute heart failure is a potentially life-threatening condition, reaching mortality rates of up to 50% in advanced cases. The investigators have shown that infusion of ketone bodies increase cardiac output by 40% in stabile patients with chronic heart failure. However, there are no data showing the effects of ketone on patients with acute heart failure Objectives: To investigate the effect of ketone supplementation in patients with acute heart failure and cardiogenic shock, using two different types of oral ketone supplements. Methods: The investigators will conduct four randomized placebo-controlled studies, to investigate the hemodynamic effect of exogenous ketones in acute heart failure and cardiogenic shock. Perspectives: The present study will determine the potential beneficial effects of ketone supplements in patients with acute heart failure.

This is a prospective, multi-center, unblinded, randomized, controlled, and non-inferiority study comparing the EVA2 LVAS to the most recent magnetically levitated centrifugal LVAS (HM3 LVAS).

The main objective of this study is to determine the clinical efficacy of metformin versus placebo and the therapeutic response with regards to functional capacity and hemodynamics in PH-HFpEF.

Aims: To explore the clinical effect on exercise tolerance and quality of life, safety and tolerability of pacing at higher outputs in patients with chronic heart failure and a pacemaker. Background: Heart failure (HF) is a very common condition of breathlessness or fatigue associated with heart muscle weakness. In around 30% of people with HF, a pacemaker-based treatment known as cardiac resynchronization therapy (CRT) can improve symptoms and prognosis by retuning the timing of the contraction of the heart. However, the effect of CRT is variable and unpredictable, with around 1 in 3 of people obtaining no obvious symptomatic benefit. One of the reasons for this might be that the pacemaker pulse does not activate all of the heart muscle cells at the same time or at all. In order to provide the longest possible battery life span, the default programming for all pacemakers is to provide a stimulus at an arbitrary level above the capture threshold (at which the spike leads to contraction). Whilst this is reasonable in a normal heart where the aim is to treat a slow heart rate, in heart failure, where the aim is to retune all parts of the heart, it is possible that this is not enough to provide consistent contraction of all heart muscle cells. It is possible that providing a higher output electrical signal from the pacemaker will activate more of the heart muscle cells immediately and thereby improve the contraction of the heart. The investigators think that this might be important at rest, but even more important during activity. This concept has never been tested before in a systematic manner but could have large implications for people with heart failure and existing CRT devices which could simply be reprogrammed to derive greater benefits for patients during everyday activities. Design: The proposed project has two parts: Study 1 - 105 patients with a CRT pacemaker for heart failure but ongoing symptoms will be invited to attend the National Institute of Health Research Clinical Research Facility. Symptoms, medication, hospitalisation information will be collected and a heart ultrasound scan using the pacemaker to increase the heart rate will be done to describe the force frequency relationship. Patients will perform a cardiopulmonary exercise test. Of these patients, 40 will be invited to return for two further visits, to perform an exercise test each time with the pacemaker programmed to its usual output or high output pacing. At each visit, including the heart scans, the order of the programming will be random, and neither the observer nor the patient will know how the device has been programmed. Study 2 - 70 patients will be invited to participate in a longer term study of whether high output pacing is safe, well tolerated and has effects on walk time (on a treadmill) and heart pumping function. Participants will be randomly allocated to one of two groups: high output or standard pacemaker settings. In the high output group, the pacemaker will be programmed to deliver the highest output possible or tolerated. In the standard care group patients will have standard output settings.

This study investigates the effects of a 12-week high-intensity interval training (HIT) on exercise tolerance, functional status and quality of life in patients with chronic heart failure with preserved ejection fraction (HFpEF), in comparison to a control group undergoing a 12-week moderate-intensity continuous training.

Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).

Rationale: Atrial fibrillation (AF) and heart failure (HF) can cause each other and sustain each other. Combined, the two diseases negatively influence each other's prognosis and lead to higher mortality. Studies in HF patients in which the AF burden is reduced by AF ablation show promising results toward improved prognosis, but so far only one randomized trial is conducted that focused on major clinical endpoints. As the selected patients in this trial were not representative for the entire population and its ablation method varied from patient to patient, it is the aim of the present study to confirm that early invasive therapy consisting of a strict pulmonary vein isolation (PVI) protocol using cryoballoon therapy has positive effects on hard clinical endpoints in a wider variety of patients in the HF population. Furthermore, there are no studies which compare cost-effectiveness of an early invasive strategy in this patient category. The investigators expect that avoided hospitalizations and healthcare resource utilizations lead to lower costs in the AF ablation group, despite initial higher costs of the procedure. Objective: To compare outcome and cost-effectiveness of early AF ablation by PVI using cryoballoon therapy with standard (medical) therapy in patients with heart failure with reduced ejection fraction. Study design: Multicenter, randomized, open label clinical trial. Study population: Symptomatic adult patients with heart failure with reduced ejection fraction (<40%) and paroxysmal or persistent AF. Intervention: AF ablation (PVI) using cryoballoon therapy. Outcome measures: The primary endpoint is a combined endpoint of all-cause mortality, unplanned cardiovascular hospitalization, and stroke (time-to-event analysis). Secondary endpoints of the trial are: A combined endpoint of mortality, number of unplanned cardiovascular hospitalizations, and stroke (recurrent-event analysis); A hierarchical endpoint of mortality, unplanned cardiovascular hospitalizations, stroke, and HF complaints; Cost-effectiveness. Key exploratory endpoints include individual components of the combined endpoints, days alive out of the hospital, hospitalizations for heart failure, recurrence of atrial arrhythmia, and quality of life.

Mineralocorticoid receptor antagonists (MRA) is one of cornerstones in the treatment of heart failure with reduced ejection fraction (HFrEF). However, MRA has been extremely under-used globally. The main reason for this seems to be increased risk of hyperkalemia in individuals on MRA. Theoretically, by limiting the risk of hyperkalemia it could thus be possible to optimize MRA therapy. This is studied in this randomized controlled trial in which it is investigated whethere adding a potassium-binder in combination with MRA treatment prevent hyperkalemia to a greater extent than only using MRA. The specific aim of this study is to demonstrate the efficacy and safety of Sodium Zirconium Cyclosilicate (SZC) in optimizing MRA in symptomatic patients with HFrEF. A multicenter, randomized, placebo-controlled, double-blinded study in Sweden (n=110) The study consists of 2 phases: 1) open-label run-in within maximum 2 months, where all are treated with SZC to test tolarability, and 2) a 1:1 randomized, double-blinded and placebo-controlled treatment during 6 months. The open-label phase, in turn, consists of three periods: run-in (1 - 2 weeks), correc-tion (maximum 72 hours) and maintenance (4-7 weeks). In addition, post-randomization phase, all patients will be followed by 3 visits (Follow-Up 1, 2 and 3) at 1, 2 and 4 weeks after End of Study (EOS) / End of Treatment (EOT) (which comes first) for further control of kalium and creatinine levels and documentation of current MRA use incl dose. Sodium Zirconium Cyclosilicate (SZC) (Lokelma)®, 5 g, 10 g, orally, is an approved drug in Sweden. For correction of hyperkalemia, the recommended starting dose is 10 g, three times daily. Once normokalemia has been achieved, the maintenance reg-imen should be started with 5 g once daily. The dose can be titrated up to 10 g once daily or lowered to 5 g once every other day as needed, to maintain a normal level of potassium. Primary Objective: To demonstrate the efficacy of Sodium Zirconium Cyclosilicate (SZC) on optimiz-ing MRA in HFrEF, SZC vs Placebo. Outcome measure: Whether a patient maintains MRA either at a dose ≥ 25 mg daily (for those without MRA at base-line) or a dose increase by 25 mg daily (for those with MRA ≤ 25 mg daily at baseline) and K level in the normal range (3.5-5.0 mmol/L) at the end of study, without rescue therapy due to hy-perkalemia at any point during the randomization phase.

The main objective of this study is to evaluate the efficacy of SZC as compared with placebo in keeping potassium levels within the normal range (3.5-5.0 mEq/L) while on spironolactone ≥25 mg daily without assistance of rescue therapy for hyperkalaemia (HK).

The study compares standard right ventricle apical pacing with so called His-bundle pacing, for patients with slightly or moderately reduced ejection fraction and atrioventricular block requiring pacemaker therapy. The primary outcome is left ventricular ejection fraction measured after 6 months.