Tracking metabolic responses to heart failure medications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.