Metabolic Response to the Initiation of Heart Failure Therapy (GliF Study)

Status: Recruiting
Study Type: Observational
SUMMARY

This protocol is a component of the CarDia project under the National Institute for Metabolic and Cardiovascular Disease Research (EXCELES Program, ID: LX22NPO5104), which is financed by the European Union - Next Generation EU. It falls under Work Package 5 (WP5), focusing on metabolic disorders in heart failure. The aim of this observational protocol is to track the biochemical and metabolomic reactions to the commencement of standard heart failure medications (SGLT2i, soluble guanylate cyclase-sGC stimulators, sacubitril/valsartan-ARNI) and to assess if the initial response (within the first three months) can predict the disease's progression. The protocol will investigate the temporal changes in parameters that indicate neurohumoral activation, hypoxia response, systemic energy substrate metabolism, iron metabolism, and HIF1A activation in peripheral blood following the initiation of standard heart failure therapy (baseline, 1 day, 1 week, 1 month, 3 months). This study could yield crucial insights into identifying individuals who exhibit a poorer response to the new treatment and are at a higher risk of an unfavorable disease trajectory. Patients will be compared with a control group, who are those without any therapy alteration during the initial observation period (3 months). As an observational study, the decision to initiate therapy will be based solely on medical indications. Heart failure patients at the Cardiocenter of the Institute for Clinical and Experimental Medicine - IKEM in Prague, CZ will undergo blood sampling at specific intervals before and after the initiation of clinically indicated treatment. A subset of patients will also receive genetic DNA testing to explore gene variability that influences the metabolic neurohumoral response to heart failure. Patients will be followed up at 1 and 2-year intervals to monitor the occurrence of clinical events. The study's observational nature ensures that participation does not influence the standard of care or pharmacotherapy selection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ability to give written informed consent

• Heart failure New York Functional class (NYHA) II-IV with duration more than 3 months (regardless ejection fraction, universal definition of HF)

• NTproBNP more than 125 pg/ml at screening (Universal definition of HF)

• O2 sat more than 90%

Contact Information
Primary
Vojtech Melenovsky, MD, PhD, Prof.
vome@ikem.cz
420 236055190
Time Frame
Start Date: 2024-08-23
Estimated Completion Date: 2026-12-20
Participants
Target number of participants: 120
Treatments
HF patients initiated with sodium-glucose transport protein 2 (SGLT2) inhibitor
HF patients with medical indication to initiation of SGLT2 inhibitors
HF patients initiated with soluble gluanylate cyclase (sGC) stimulator
HF patients with medical indication to initiation of sGC stimulator
HF patients initiated with sacubitril/valsartan (ARNI)
HF patients with medical indication to initiation of ARNI
HF patients without change of their chronic medication
these HF patients (without ARNI, sGCs or SGLT2i) will serve as internal controls during observational part of the study (3 mo)
Related Therapeutic Areas
Sponsors
Leads: Vojtech Melenovsky, MD, PhD

This content was sourced from clinicaltrials.gov