Active clinical trials for "Heart Failure"

The goal of this observational study is to develop longitudinal multimarker risk models for decision support during the clinical follow-up of very elderly patients with heart failure and preserved ejection fraction (HFpEF). The main questions it aims to answer are: Can advanced risk prediction models accurately estimate the prognosis of very elderly patients with HFpEF over a 1-year follow-up after a hospitalization for acute heart failure? Do novel biomarkers, in addition to routine clinical variables and elderly-specific predictors, contribute to improved risk prediction for these patients? To this end, very elderly patients (aged 80 or older) who have HFpEF and were admitted for acute heart failure will be included. Clinical and biological data will be collected during their hospitalization and also during follow-up visits 30 and 90 days after discharge. There is no comparison group in this observational study.

Severe skeletal wasting and catabolic weight loss are highly common among patients with heart failure with reduced ejection fraction (HFrEF). This prospective randomized controlled trial will compare changes in the muscle mass in the arms and the legs (appendicular lean mass) in patients with HFrEF randomized between 3 groups of no, low- or high-dose protein supplementation. The dietary protein supplementation will be Ensure(R) products manufactured by Abbott Nutrition. The Investigators hypothesize that skeletal muscle wasting in HFrEF is promoted by neurohumoral activation of catabolic metabolism (such as GDF-15 and ActRII pathways) and can be at least partially reversed by increased dietary protein intake. It is anticipated that this study will determine whether dietary protein supplementation helps to prevent muscle wasting and will advance understanding of the GDF-15 and ActRII muscle wasting pathways.

The study investigates wheather CTO-PCI improves survival and heart failure related rehospitalization compared to optimal medical therapy (OMT). This hypothesis will be investigated within a large-scaled international, representative, prospective, randomized, controlled, open-label, event-driven, multicentre trial (trial acronym: CTO - Heart Failure) recruiting patients with planned CTO-PCI.

The goal of this randomized, controlled, open-label, interventional study is to evaluate whether, in patients with heart failure (HF) and iron deficiency (ID), the administration of vitamin D in combination with sucrosomial iron is as effective as intravenous ferric carboxymaltose in improving symptoms of HF. The main hypothesis which the study aims to test is the non-inferiority of sucrosomial iron (± vitamin D) compared with FCM treatment, after 24 weeks. Primary endpoint: the performance of the Six-Minute Walking Test, comparing the mean difference from baseline of the distance walked by patients in meters. Participants will be evaluated in outpatient scheduled visits at 6, 12 and 24 weeks, performing blood tests, clinical evaluation, instrumental investigations and recording any adverse events, cardiovascular events, re-hospitalizations and fractures. The study will involve randomization into 3 groups with a 1:1:1 ratio: Control group [standard of care]: administration of FCM (Ferinject®) with a dose between 500 and 2000 mg (depending on body weight and hemoglobin values), to be administered in 1 or 2 doses (time 0 ± 6 weeks) with possible additional administration of 500 mg at week 12 in case of persistent ID. Sucrosomial iron group: administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once a day for 24 weeks. Sucrosomial iron and vitamin D group: administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once daily + vitamin D3 (100,000 IU load at time 0, then 2,000 IU daily) for 24 weeks

Telemedicine is gradually becoming accepted in heart failure (HF) management. Meta-analyses show a positive effect of telemedicine on hospital admission, length of stay, mortality, and costs. However, the magnitude of the effect is heterogeneous because of the variety in the HF population using telemedicine, components of telemedicine, and variety in considered costs. Despite the lack of clear guidance how to implement telemedicine within routine HF management, implementation of telemedicine is advocated by payers, private companies, and patient organizations. In this nationwide study the investigators aim to identify in which subgroup of HF patients telemedicine is (cost-)effective, and which intervention components of telemedicine are most (cost-)effective.

To assess the discriminative properties of pleural fluid (PF) N-terminal-proB-type-natriuretic-peptide (NTproBNP) levels in identifying heart failure (HF)-associated pleural effusions (PE).

The goal of this clinical trial is to study if an investigational study drug called Dapagliflozin could prevent heart failure from getting worse in adults with Fontan circulation. The main questions it aims to answer are: Does Dapagliflozin decrease Fontan pressure? Does Dapagliflozin improve exercise capacity and heart failure symptoms? Participants will have 4 study visits and 2 follow-up phone calls. The total duration of participation in the study will be up to 5 weeks from the time of screening to the completion of the final safety evaluation. Study procedures include the collection of study-related health information and blood samples, physical examination, exercise testing, total body water assessment, blood laboratory testing, health status survey, safety evaluation phone calls, and home blood pressure monitoring.

Dapagliflozin is a molecule belonging to the class of sodium-glucose transporter type 2 (SGLT2-i) inhibitors. This type of drug, initially used in the treatment of diabetes mellitus, has in recent years demonstrated significant prognostic benefit in patients with heart failure even in the absence of diabetes mellitus. The new international heart failure guidelines have taken up this evidence by suggesting the use of SGLT2-i therapy in patients with heart failure with reduced ejection fraction (HFrEF). Given the drug's recent introduction into clinical routine, the evaluation of "field" experience is important to refine the clinical management of patients treated with SGLT2-i. Moreover, SGLT2-i has currently been shown to be effective in some small preliminary studies in improving ejection fraction and some echocardiographic parameters of ventricular remodelling on top of concomitant optimal medical therapy, although further data are needed in this regard. In particular, the potential benefit of SGLT2-i therapy on exercise capacity, respiratory function parameters, biomarkers and left ventricular remodelling in patients with heart failure has not been extensively studied at present. In this regard, the cardiopulmonary exercise test (CPET) allows the derivation of prognostic functional parameters in patients with chronic heart failure such as peak VO2 and the ventilation/CO2 slope. CPET is a valid, recognised and accurate tool for risk stratification in patients with heart failure. In addition, there are no data available on the effect of SGLT2-i on lung diffusion (DLCO) and specific markers of the alveolar-capillary membrane, such as surfactant binding proteins, as well as on the presence of sleep apnoea, a particularly relevant parameter for the prognosis of decompensated patients. The aim of the study is to evaluate changes in exercise capacity, spirometry, DLCO, echocardiographic parameters of left ventricular systolic-diastolic function, Nt-proBNP dosage, ST-2, surfactant binding proteins, sleep apnoea, impedance measurement and quality of life in a single-centre cohort of 70 patients with heart failure with stable reduced left ventricular ejection fraction (functional class NYHA II and III) and guideline candidates for treatment with Dapagliflozin. Patients will undergo, as per regular clinical practice, an initial assessment (baseline) that will include a clinical evaluation, KCCQ questionnaire for quality of life assessment, spirometry, DLCO, impedance measurement, polysomnography, a cardiopulmonary ramp test, blood tests with dosage of Nt-proBNP, ST-2 and surfactant binding protein, and a standard transthoracic echocardiogram. At baseline, the patient will start treatment with Dapagliflozin at the standard dosage of 10mg/day. A similar evaluation with the same study procedures will be performed 6 months after the start of therapy. A re-evaluation of the patient including venous blood sampling is planned between 2 and 4 weeks after the start of Dapagliflozin from clinical practice. In the context of this sampling, the assay of the biomarkers under study will also be repeated.

This study has been implemented to evaluate cardiac resynchronization therapy pacemaker (CRT-P) implantations on a same-day basis

Effective diuresis is the primary goal of most acute decompensated heart failure hospitalizations, but diuretic resistance is common and our ability to detect it is limited. Further, there are therapeutically distinct groups of diuretic-resistant patients. These are not easily distinguished using currently available methods, leading to trial-and-error based treatment that promotes lengthy hospitalizations. The aims of this study are: To develop inexpensive and efficient tools to predict diuretic response To understand the prevalence of therapeutically targetable mechanisms of diuretic resistance using endogenous lithium clearance To develop methodology to differentiate diuretic resistance mechanisms using common/inexpensive laboratory tests To provide proof of concept that mechanistically tailored diuretic therapy can improve natriuresis