NCT06283420 Metabolic Response to the Initiation of Heart Failure Therapy
| NCT ID | NCT06283420 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vojtech Melenovsky, MD, PhD |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-08-23 |
| Primary Completion | 2025-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-08-23 with a primary completion date of 2025-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06283420 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06283420 currently recruiting?
Yes, NCT06283420 is actively recruiting participants. Contact the research team at vome@ikem.cz for enrollment information.
Where is the NCT06283420 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT06283420 clinical trial?
NCT06283420 is sponsored by Vojtech Melenovsky, MD, PhD. The trial plans to enroll 120 participants.
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