Metabolic Response to the Initiation of Heart Failure Therapy
- Conditions
- Heart Failure
- Registration Number
- NCT06283420
- Lead Sponsor
- Vojtech Melenovsky, MD, PhD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria:<br><br> - ability to give written informed consent<br><br> - Heart failure New York Functional class (NYHA) II-IV with duration more than 3<br> months (regardless ejection fraction, universal definition of HF)<br><br> - NTproBNP more than 125 pg/ml at screening (Universal definition of HF)<br><br> - O2 sat more than 90%<br><br>Exclusion Criteria:<br><br> - Previous SGLT2 inhibitor therapy or i.v., iron therapy in past 3 months (for SGLT2i<br> arm)<br><br> - Previous sGC stimulator (for sGC arm), or previous ARNI (for ARNI arm), or previous<br> SGLT2i, sGC or ARNI for control group.<br><br> - Coronary artery bypass grafting (CABG), cardiac resynchronisation therapy (CRT),<br> STEMI, valve replacement, in past 3 months, or planned within next 3 months<br><br> - Blood loss needing transfusion in past 3 months<br><br> - Clinical instability (including HF hospitalization) in the past 1 month<br><br> - Myelodysplasia, chronic hemolysis, erythropoetin therapy<br><br> - Systemic inflammatory condition (lupus, rheumatoid arthritis...) or infection<br><br> - Uncontrolled cancer<br><br> - Chronic kidney disease (CKD) grade 4-5<br><br> - Severe anemia with Hgb less than 90 g/L<br><br> - No chronic exposure to hypoxia (severe chronic obstructive pulmonary disease,<br> obstructive sleep apnoea, long-term oxygen therapy)<br><br> - History of SGLT2i allergy or intolerance<br><br> - Repeated genitourinary infection
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method hematocrit
- Secondary Outcome Measures
Name Time Method Hypoxia inducible factor (HIF) response;hepcidin