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Heart Failure clinical trials

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NCT ID: NCT06285565 Not yet recruiting - Heart Failure Clinical Trials

A Nurse-led Coaching Programme With Telemonitoring in Heart Failure

INTERCOACH
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The goal of this pilot interventional study is to assess the feasibility and acceptability of a supportive intervention for patients affected by heart failure. The main questions it aims to answer are: - Are implementation strategies effective in facilitating participant fidelity? - What factors contribute to patients' satisfaction with the designed intervention, and how can these be optimized for improved patient experience and adherence? - Are the methods and tools established the most appropriate to ensure the completeness of the data collection? Participants will follow a combined intervention consisting of: 1. pre-discharge educational meeting; 2. telephone nurse-led coaching sessions; 3. home telemonitoring of vital signs. In the main trial, researchers will compare data from the intervention group with a control group to assess whether it reduces hospitalization rates and improves self-care capabilities

NCT ID: NCT06283420 Not yet recruiting - Heart Failure Clinical Trials

Metabolic Response to Iniciation of Heart Failure Therapy

GliF
Start date: February 21, 2024
Phase:
Study type: Observational

This protocol is part of the CarDia project - National Institute for Metabolic and Cardiovascular Disease Research (EXCELES Program, ID: LX22NPO5104), funded by the European Union - Next Generation EU. The protocol is part of Work Package 5 (WP5): metabolic disorders in heart failure. The goal of this observational protocol is to monitor the biochemical and metabolomic response to the initiation of therapy for heart failure with standard drugs (SGLT2i, sGC stimulators, ARNI) and whether this early response (within first 3 months) predicts the further course of the disease. The protocol will examine how parameters reflecting neurohumoral activation, response to hypoxia, systemic metabolism of energy substrates, parameters of iron metabolism, HIF1A activation in peripheral blood behave over time after starting standard heart failure terapiy (baseline, 1 day, 1 week, 1 month, 3 month). This project can provide valuable information on how to identify people who respond more poorly to the treatment being introduced and are more at risk of an adverse course of the disease. Patients will be compared to patients who have no change of therapy over early observation period (3 mo), who will serve as controls. This is observational study, so decision to inicialize therapy will be based on medical indication. Patients with heart failure treated at the IKEM Cardiocenter will have blood drawn at several defined intervals before and after the start of clinically indicated treatment. Some patients will also undergo genetic DNA testing to determine the variability of genes regulating the metabolic neurohumoral response to heart failure. Patients will be contacted at intervals of 1 and 2 years and the incidence of clinical events will be monitored. The study is observational in nature and inclusion in the study does not affect the course of care provided or the choice of pharmacotherapy.

NCT ID: NCT06282822 Not yet recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Shear Wave Elastography for Diagnosis of Heart Failure With Preserved Ejection Fraction

Start date: March 1, 2024
Phase:
Study type: Observational

The diagnosis of heart failure with preserved ejection fraction (HFpEF) is often complex. Echocardiography has the advantages of being a non-invasive, simple operation, low price, and high repeatability, and is of great value in the diagnosis of HFpEF. However, the current echocardiographic assessment of left ventricular diastolic dysfunction and elevated filling pressure is based on multi-parameter indirect judgment, and new parameters are urgently needed to achieve accurate judgment of left ventricular diastolic function and an accurate diagnosis of HFpEF. Myocardial stiffness refers to the ability of the myocardium to undergo stress and strain. It is an important part of the pathophysiology of cardiac diastolic dysfunction and an important parameter for clinical evaluation of the diastolic function of HFpEF. Shear-wave elastography is a novel ultrasound-based elastography technology. Based on the shear wave generated by the remote induction of the radiation force of the focused ultrasound beam, the hardness of myocardial tissue can be measured quantitatively, locally, and noninvasively, and the change in myocardial stiffness in patients with HFpEF can be directly reflected. Currently, no relevant studies have applied shear-wave elastography to the diagnosis of HFpEF. This study aims to identify changes in myocardial stiffness measured by shear-wave elastography in patients with HFpEF based on a multicenter study and apply myocardial stiffness parameters to the diagnosis of HFpEF.

NCT ID: NCT06280820 Not yet recruiting - Heart Failure Clinical Trials

Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)

Start date: June 26, 2024
Phase:
Study type: Observational

Background: More than 6.5 million people in the United States live with heart failure (HF), and more than a million new cases are diagnosed each year. Treatments have improved in recent years, but researchers want to understand more about how HF develops. To do this, they need to compare blood and other samples from many people with HF. Objective: To collect blood and other samples from people with HF. These samples will be used to identify and study proteins and other factors that may lead to decreased heart function over time. Eligibility: People aged 18 years and older with heart failure. Design: Participants will be asked to join the study based on a review of their medical records. They will have 1 study visit. They will provide a blood sample: About 3 tablespoons will be collected from a needle inserted into a vein. Other tests are optional: Participants may provide urine and stool samples. They may have a cotton swab rubbed on the inside of the mouth to collect DNA. Participants may also take 3 questionnaires. They will answer questions about dietary, social, and other factors that affect their health. Participants will receive compensation. Researchers will follow the participants health by monitoring their medical records for up to 5 years.

NCT ID: NCT06279988 Recruiting - Heart Failure Clinical Trials

BRING-UP 3 Heart Failure

BRING-UP3HF
Start date: September 15, 2023
Phase:
Study type: Observational

The aim of this observational study is to assess the level of adherence to guideline recommendations regarding the management of patients with Heart Failure with Reduced Ejection Fraction (HFrEF); - the safety profile of the implementation of recommended treatments; - to monitor treatment patterns of patients with acute hert failure (HF); - to monitor treatment patterns of all patients with chronic HF irrespective of the level of ejection fraction (EF).

NCT ID: NCT06278844 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication

ESCPAND
Start date: December 12, 2023
Phase: N/A
Study type: Interventional

This randomized controlled trial aims to investigate the impact of conduction system pacing in comparison to right ventricular apical pacing on exercise capacity, as measured by peak oxygen uptake (VO2peak), in heart failure patients with indication for pacing but no compelling indication for cardiac resynchronization therapy (CRT). The mechanisms of exercise intolerance in heart failure patients influenced by conduction system pacing will be assessed.

NCT ID: NCT06278792 Completed - Clinical trials for Acute Decompensated Heart Failure

Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure

EASY-HF
Start date: March 7, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare physician-guided (SOC) versus nurse-led natriuresis-guided diuretic therapy in patients with acute decompensated heart failure (ADHF). The main questions it aims to answer are: - difference in natriuresis and diuresis - feasibility of the protocol. Participants will be asked to gather two 24 h urine collections. Researchers will compare SOC versus nurse-led diuretic titration to see if there is a difference in natriuresis after 48 hours.

NCT ID: NCT06278727 Recruiting - Heart Failure Clinical Trials

Development and Validation of the Prediction Model for Functional Mitral Regurgitation Regression in Heart Failure Patients Taking Guideline-directed Medical Therapy

Start date: January 1, 2024
Phase:
Study type: Observational

This observational study is to develop and validate the prediction model for functional mitral regurgitation regression in heart failure patients taking GDMT. The patients diagnosed ≥2+ functional mitral regurgitation by ultrasonic cardiogram are enrolled in this study and would be clinically followed by at least one year (clinical visit at 3 months, 6 months, and 12 months), and then by when the endpoints are reached.

NCT ID: NCT06273397 Not yet recruiting - Clinical trials for Decompensated Heart Failure

Acetazolamide or Metolazone in Acute Heart Failure

ACME-AHF
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Impact of Acute Heart Failure: According to the World Health Organization (WHO), approximately 26 million people suffer from Heart Failure (HF), with a mortality rate of up to 50% within five years of diagnosis. Acute Heart Failure (AHF) exacerbations, leading to hospitalization, are common and represent the primary cause of hospital admissions in those over 65. Effective decongestion during hospitalization is crucial, as failure to achieve it doubles the risk of rehospitalization and mortality, incurring significant healthcare costs. Use of Diuretics in Acute Heart Failure: Diuretics, particularly loop diuretics like furosemide, are a cornerstone in managing AHF by inducing natriuresis and achieving decongestion. Clinical experience supports their use, though limited clinical trials exist. Pharmacological concepts guide their administration, emphasizing intravenous delivery in high doses and adjusting subsequent doses based on decongestive efficacy. Additionally, sequential tubular blockade with other diuretics like metolazone and acetazolamide is explored to enhance decongestion. Use of Metolazone and Acetazolamide: Sequential tubular blockade, using metolazone and acetazolamide in conjunction with furosemide, aims to achieve rapid and effective decongestion. While metolazone targets the distal tubule, inhibiting sodium-chloride channels, acetazolamide affects proximal tubular function. Studies like ADVOR (acetazolamide) and CLOROTIC (thiazide-like diuretic) demonstrate the potential benefits of combining these diuretics for quicker decongestion but with potential risks (in the case of Hydrochlorothiazide). Outcomes Measured by Major Studies: Recent studies assessing decongestion in AHF reveal a lack of uniformity in outcome selection. The primary focus should be on reducing rehospitalizations and post-discharge mortality by achieving effective decongestion. The ADVOR study, using a simple congestion score based on clinical and imaging criteria, underscores the importance of reaching a congestion score of 0 or 1 promptly. Congestion Monitoring: Monitoring diuretic treatment solely based on clinical aspects may not capture subclinical congestion, necessitating biochemical and imaging parameters. The ACME-AHF trial proposes a diagnostic score integrating clinical and imaging aspects to evaluate congestion status. Secondary outcomes include cumulative diuresis, weight loss, diuretic efficiency, and natriuresis, with a focus on natriuresis as a reliable physiological parameter for decongestion. Aim of the study: The ACME-AHF trial is designed to compare the efficacy and safety of two diuretic combination strategies: acetazolamide with furosemide and metolazone with furosemide. The primary objective is to relieve congestion, assessed using a congestion score, within the first three days of treatment during an hospitalization for acute heart failure.

NCT ID: NCT06273280 Active, not recruiting - Heart Failure Clinical Trials

Renal-based Optimization of QUADruple Therapy in Patients With Heart Failure With Reduced Ejection Fraction.

ReQUAD-HF
Start date: February 14, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate guideline-directed medical therapy (GDMT) up-titration in patients with heart failure with reduced ejection fraction.The main question it aims to answer is the improvement in prescription rate and dose uptitration of quadruple GDMT in patients with HFrEF, assessed by a weighed composite score. Participants will be randomized towards control (standard of care, SOC) or intervention group. Researchers will compare SOC with protocol-based up-titration to see if the protocolized optimization improves prescription rate of GDMT.