Actively Recruiting
Metabolic Response to the Initiation of Heart Failure Therapy
Led by Vojtech Melenovsky, MD, PhD · Updated on 2024-08-27
120
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Metabolic Response to the Initiation of Heart Failure Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide written informed consent
- Diagnosed with heart failure classified as New York Heart Association (NYHA) class II to IV lasting more than 3 months
- NTproBNP blood level above 125 pg/ml at screening
- Oxygen saturation higher than 90%
You will not qualify if you...
- Previous treatment with SGLT2 inhibitors or intravenous iron therapy within the last 3 months for the SGLT2 inhibitor group
- Previous use of soluble guanylate cyclase stimulators for the sGC group or previous use of sacubitril/valsartan for the ARNI group
- Previous treatment with SGLT2 inhibitors, sGC stimulators, or ARNI for the control group
- Coronary artery bypass grafting, cardiac resynchronization therapy, heart attack (STEMI), or valve replacement within the last 3 months or planned within the next 3 months
- Blood loss requiring transfusion in the past 3 months
- Clinical instability including hospitalization for heart failure within the past month
- Conditions such as myelodysplasia, chronic hemolysis, or erythropoietin therapy
- Systemic inflammatory diseases like lupus or rheumatoid arthritis, or infection
- Uncontrolled cancer
- Chronic kidney disease at stage 4 or 5
- Severe anemia with hemoglobin less than 90 g/L
- Chronic exposure to low oxygen conditions such as severe chronic obstructive pulmonary disease, obstructive sleep apnea, or long-term oxygen therapy
- Known allergy or intolerance to SGLT2 inhibitors
- Repeated genitourinary infections
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institute for Clinical end Experimental Medicine - IKEM
Prague, Czechia
Actively Recruiting
Research Team
V
Vojtech Melenovsky, MD, PhD, Prof.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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