Metabolic Response to Iniciation of Heart Failure Therapy

Heart Failure Clinical Trial

— GliF  

Official title:

Metabolická Odpoved na Zahajeni Lecby Srdecniho Selhani

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06283420
• Other study ID #: CarDia_WP5_P1_IRB:25059/23
• Status: Not yet recruiting
• Start date: February 21, 2024
• Est. completion date: December 20, 2026

Study information

• Verified date: February 2024
• Source: Institute for Clinical and Experimental Medicine
• Contact: Vojtech Melenovsky, MD, PhD, Prof.
• Phone: 420 236055190
• Email: vome[@]ikem.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 20, 2026
• Est. primary completion date: December 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

ability to give written informed consent Heart failure NYHA II-IV with duration > 3 months (regardless EF, universal definition of HF) NTproBNP: > 125 pg/ml at screening (Bozkut Univ. definition of HF) O2 sat > 90%

Exclusion Criteria:

Previous gliflozin or i.v., iron therapy in past 3 months (for SGLT2i arm) Previous sGC stimulator (for sGC arm) Previous ARNI (for ARNI arm) Previous SGLT2i, sGC or ARNI for control group. CABG, CRT, STEMI, valve replacement, in past 3 months, or planned within next 3 months Blood loss needing transfusion in past 3 months Clinical instability (including HF hospitalization) in the past 1 month Myelodysplasia, chronic hemolysis, EPO therapy Systemic inflammatory condition (lupus, rheumatoid arthritis...), infection Uncontrolled cancer CKD grade 4-5 Severe anemia with Hgb < 90 g/L No chronic exposure to hypoxia (severe COPD, OSA, long-term oxygen therapy) History of SGLT2i allergy or intolerance Repeated genitourinary infection

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Czechia	Institute for Clinical end Experimental Medicine - IKEM	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Vojtech Melenovsky, MD, PhD

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hematocrit	full blood count hematocrit	difference 3 mo-baseline
Secondary	HIF response	gene expression of HIF1A-regulated genes in platelets	baseline, 1 day, 1 week, 1 mo and 3 mo after baseline
Secondary	hepcidin	hepcidin plasma concentration	baseline, 3 months