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Metabolic Response to the Initiation of Heart Failure Therapy

Recruitingn/aAges 18 Years - anyAllVojtech Melenovsky, MD, PhD
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Institute for Clinical end Experimental Medicine - IKEM
Prague, Czechia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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