Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06283420
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2024-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metabolic Response to the Initiation of Heart Failure Therapy
Sponsor:
Vojtech Melenovsky, MD, PhD
Organization:
Study Overview
Official Title:
Metabolic Response to the Initiation of Heart Failure Therapy (GliF Study)
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GliF
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: