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Reduced Ejection Fraction clinical trials

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NCT ID: NCT06115928 Not yet recruiting - Heart Failure Clinical Trials

Effects of Virtual Reality on Rehabilitation in Patients With Heart Failure

VIRTUAL-HF
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Background. To improve symptoms and reduce poor outcomes related to heart failure (HF), international guidelines recommend cardiac rehabilitation (CR), particularly for those with a reduced ejection fraction. Unfortunately, patient adherence to rehabilitation programs remains suboptimal, with dropouts ranging from 15.4 to 63.3%. An innovative and promising intervention that could improve adherence to rehabilitation is virtual reality (VR). This study aims to evaluate the effects of VR in patients with HF undergoing CR in terms of adherence (primary outcome), functional capacity, perceived exertion, angina, quality of life, heart rate, oxygen saturation, blood pressure, maximum oxygen uptake, minute ventilation/carbon dioxide production slope, oxygen pulse, blood values of NT-proBNP and rehospitalization rates due to HF (secondary outcomes). Methods. A randomized controlled trial will be conducted in a sample of 80 patients referred to CR. Participants will be enrolled in a cardiological rehabilitation unit of a large university hospital in Italy and randomized (1:1) to the experimental intervention consisting of CR performed with high-quality immersive VR with PICO 4® Head Mounted Display headset and TREADMILL XR® software (Arm 1) or standard CR (Arm 2). Patients will receive 30-minute CR sessions twice a week for one month. Results. Significant improvements in primary and secondary outcomes are expected in patients in the intervention group. Conclusions. If proven to be effective, VR could be an innovative, safe, and easy digital health intervention to improve adherence to CR in patients with HF, as well as important clinical outcomes.

NCT ID: NCT05420285 Recruiting - Heart Failure Clinical Trials

Cardiometabolic Effects of Dapagliflozin in Heart Failure With Reduced or Mildly Reduced Ejection Fraction

ICARD
Start date: June 26, 2022
Phase: Phase 2
Study type: Interventional

Gliflozins have demonstrated a beneficial effect in terms of incident heart failure and related events in patients with or without diabetes. The clinical trial ICARD is an exploratory study that aims to evaluate the cardiometabolic mechanistic effects on the myocardium of dapagliflozin in heart failure with reduced ejection fraction. Deep phenotyping of cardiac and vascular function will be performed using MRI. Myocardial tissue characterization will be based on MRI and FDG-PET for glucose metabolism assessment. Liver steatosis and fibrosis will simultaneously be assessed.

NCT ID: NCT04698954 Completed - Clinical trials for Chronic Heart Failure

Evaluating the Adherence Improving Self-Management Strategy Intervention in Chronic Heart Failure Patients

AIMS-CHF RCT
Start date: December 14, 2020
Phase: N/A
Study type: Interventional

Patient non-adherence to treatment recommendations is common and decreases the effectiveness of Chronic Heart Failure (CHF) treatment. Improving adherence towards medication intake, physical activity, symptom monitoring/management might prolong life, alleviates symptoms, increases quality of life, and reduces hospital admissions. The Adherence Improving self-management Strategy (AIMS) is a nurse delivered intervention, integrated in routine clinical care, aiming to better support patients in their treatment. AIMS has previously been demonstrated to be (cost) effective amongst HIV patients. Based on the literature and advisory boards with healthcare providers and CHF patients, AIMS is adapted to CHF (AIMS-CHF). The aim of the study is to evaluate the effectiveness of the AIMS intervention on adherence regarding medication, physical activity, and symptom management compared to treatment-as-usual in patients with chronic heart failure.

NCT ID: NCT03875183 Recruiting - Heart Failure Clinical Trials

Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction

TRACER-HF
Start date: January 20, 2020
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled, dose-response trial in patients with chronic stable Heart Failure (HF) and reduced Left Ventricular Ejection Fraction (LVEF) to evaluate the efficacy and safety of three INL1 doses compared with placebo. Patients will be treated for approximately 12 weeks with one of three INL1 doses: 50 mg, 150 mg, 300 mg, or, placebo capsules, taken twice daily (BID).

NCT ID: NCT02018029 Recruiting - Heart Failure Clinical Trials

Predictives Factors of Cardiac Resynchronization Therapy: a Multimodal Analysis Using 2D Speckle Tracking Echocardiography Coupled With MIBG Myocardial Scintigraphy and Heart Failure Biomarkers

PREFAC-CRT
Start date: March 2013
Phase: N/A
Study type: Observational

Cardiac resynchronization therapy (CRT) is one of the lastest recommended treatments in patients with refractory symptomatic chronic heart failure with reduced ejection fraction (HFREF). Despite clear guidelines 20 to 40 % of implanted patients are not clinically ameliorated. They are called the "non responders". Patient selection seams to be one of the key to improve the efficiency of CRT. This protocol try to assess positive predictive factors to CRT by a multimodal approach.