Metabolic Response to Iniciation of Heart Failure Therapy - Trial NCT06283420
Access comprehensive clinical trial information for NCT06283420 through Pure Global AI's free database. This phase not specified trial is sponsored by Vojtech Melenovsky, MD, PhD and is currently Not yet recruiting. The study focuses on Heart Failure. Target enrollment is 120 participants.
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Study Focus
Observational
Sponsor & Location
Vojtech Melenovsky, MD, PhD
Institute for Clinical and Experimental Medicine
Timeline & Enrollment
N/A
Feb 21, 2024
Dec 20, 2026
Primary Outcome
hematocrit
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06283420
Non-Device Trial