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Metabolic Response to Iniciation of Heart Failure Therapy (GliF)

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ClinicalTrials.gov Identifier: NCT06283420
Recruitment Status : Not yet recruiting
First Posted : February 28, 2024
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Vojtech Melenovsky, MD, PhD, Institute for Clinical and Experimental Medicine

Tracking Information
First Submitted Date February 21, 2024
First Posted Date February 28, 2024
Last Update Posted Date February 28, 2024
Estimated Study Start Date February 21, 2024
Estimated Primary Completion Date December 20, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 21, 2024)		 hematocrit [ Time Frame: difference 3 mo-baseline ]
full blood count hematocrit
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 21, 2024)
  • HIF response [ Time Frame: baseline, 1 day, 1 week, 1 mo and 3 mo after baseline ]
    gene expression of HIF1A-regulated genes in platelets
  • hepcidin [ Time Frame: baseline, 3 months ]
    hepcidin plasma concentration
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Metabolic Response to Iniciation of Heart Failure Therapy
Official Title Metabolická Odpoved na Zahajeni Lecby Srdecniho Selhani
Brief Summary

This protocol is part of the CarDia project - National Institute for Metabolic and Cardiovascular Disease Research (EXCELES Program, ID: LX22NPO5104), funded by the European Union - Next Generation EU. The protocol is part of Work Package 5 (WP5): metabolic disorders in heart failure.

The goal of this observational protocol is to monitor the biochemical and metabolomic response to the initiation of therapy for heart failure with standard drugs (SGLT2i, sGC stimulators, ARNI) and whether this early response (within first 3 months) predicts the further course of the disease.

The protocol will examine how parameters reflecting neurohumoral activation, response to hypoxia, systemic metabolism of energy substrates, parameters of iron metabolism, HIF1A activation in peripheral blood behave over time after starting standard heart failure terapiy (baseline, 1 day, 1 week, 1 month, 3 month). This project can provide valuable information on how to identify people who respond more poorly to the treatment being introduced and are more at risk of an adverse course of the disease. Patients will be compared to patients who have no change of therapy over early observation period (3 mo), who will serve as controls. This is observational study, so decision to inicialize therapy will be based on medical indication.

Patients with heart failure treated at the IKEM Cardiocenter will have blood drawn at several defined intervals before and after the start of clinically indicated treatment. Some patients will also undergo genetic DNA testing to determine the variability of genes regulating the metabolic neurohumoral response to heart failure. Patients will be contacted at intervals of 1 and 2 years and the incidence of clinical events will be monitored. The study is observational in nature and inclusion in the study does not affect the course of care provided or the choice of pharmacotherapy.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
plasma and DNA for analysis of genetic variants
Sampling Method Non-Probability Sample
Study Population Stable HF patients with HFrEF, HFmrEF or HFpEF
Condition Heart Failure
Intervention Not Provided
Study Groups/Cohorts
  • HF patients iniciated with SGLT2 inhibitor
    HF patients with medical indication to iniciation of SGLT2 inhibitors
  • HF patients iniciated with sGC stimulator
    HF patients with medical indication to iniciation of sGC stimulator
  • HF patients iniciated with ARNI
    HF patients with medical indication to iniciation of ARNI
  • HF patients without change of their chronic medication
    these HF patients (without ARNI, sGCs or SGLT2i) will serve as internal controls during oservational part of the study (3 mo)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: February 21, 2024)		 120
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 20, 2026
Estimated Primary Completion Date December 20, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

ability to give written informed consent Heart failure NYHA II-IV with duration > 3 months (regardless EF, universal definition of HF) NTproBNP: > 125 pg/ml at screening (Bozkut Univ. definition of HF) O2 sat > 90%

Exclusion Criteria:

Previous gliflozin or i.v., iron therapy in past 3 months (for SGLT2i arm) Previous sGC stimulator (for sGC arm) Previous ARNI (for ARNI arm) Previous SGLT2i, sGC or ARNI for control group. CABG, 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, EPO therapy Systemic inflammatory condition (lupus, rheumatoid arthritis...), infection Uncontrolled cancer CKD grade 4-5 Severe anemia with Hgb < 90 g/L No chronic exposure to hypoxia (severe COPD, OSA, long-term oxygen therapy) History of SGLT2i allergy or intolerance Repeated genitourinary infection
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Vojtech Melenovsky, MD, PhD, Prof. 420 236055190 vome@ikem.cz
Listed Location Countries Czechia
Removed Location Countries  
 
Administrative Information
NCT Number NCT06283420
Other Study ID Numbers CarDia_WP5_P1_IRB:25059/23
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Vojtech Melenovsky, MD, PhD, Institute for Clinical and Experimental Medicine
Original Responsible Party Same as current
Current Study Sponsor Vojtech Melenovsky, MD, PhD
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Institute for Clinical and Experimental Medicine
Verification Date February 2024