Tracking metabolic responses to heart failure medications
Metabolic Response to the Initiation of Heart Failure Therapy (GliF Study)
This study is trying to see how heart failure medications affect metabolism in patients and if these changes in the first three months can help predict how the disease will progress.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute for Clinical and Experimental Medicine Government |
| Locations | 1 site (Prague) |
| Trial ID | NCT06283420 on ClinicalTrials.gov |
What this trial studies
This observational protocol is part of the CarDia project, focusing on metabolic disorders in heart failure. It aims to monitor biochemical and metabolomic changes following the initiation of standard heart failure therapies, including SGLT2 inhibitors and ARNI. The study will assess whether the initial metabolic response within the first three months can predict disease progression by evaluating various parameters related to neurohumoral activation and metabolism. Participants will be evaluated at multiple time points: baseline, 1 day, 1 week, 1 month, and 3 months after starting treatment.
Who should consider this trial
Good fit: Ideal candidates are adults with heart failure classified as NYHA II-IV for more than three months and elevated NTproBNP levels.
Not a fit: Patients who have previously received SGLT2 inhibitors, sGC stimulators, or ARNI therapies within the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify early metabolic responses that predict heart failure progression, potentially leading to more personalized treatment strategies.
How similar studies have performed: While there have been studies on heart failure therapies, this specific approach focusing on metabolic responses is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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% Exclusion Criteria: * Previous SGLT2 inhibitor therapy or i.v., iron therapy in past 3 months (for SGLT2i arm) * Previous sGC stimulator (for sGC arm), or previous ARNI (for ARNI arm), or previous SGLT2i, sGC or ARNI for control group. * Coronary artery bypass grafting (CABG), cardiac resynchronisation therapy (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, erythropoetin therapy * Systemic inflammatory condition (lupus, rheumatoid arthritis...) or infection * Uncontrolled cancer * Chronic kidney disease (CKD) grade 4-5 * Severe anemia with Hgb less than 90 g/L * No chronic exposure to hypoxia (severe chronic obstructive pulmonary disease, obstructive sleep apnoea, long-term oxygen therapy) * History of SGLT2i allergy or intolerance * Repeated genitourinary infection
Where this trial is running
Prague
- Institute for Clinical end Experimental Medicine - IKEM — Prague, Czechia (Recruiting)
Study contacts
- Study coordinator: Vojtech Melenovsky, MD, PhD, Prof.
- Email: vome@ikem.cz
- Phone: 420 236055190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.