CArdio-Reno- Hepato -MEtabolic Disease iN Chronic Heart Failure (CARMEN-CHF)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRussian Scientific Medical Society of Therapists
About this trial
Study aims to investigate the incidence, associations and prognostic value of CRGM and its components: chronic kidney disease, type 2 diabetes, atherosclerotic cardiovascular diseases, and non-alcoholic fatty liver disease in patients with different phenotypes and severity of clinical manifestations of CHF.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years;
LVEF <50% and the presence of symptoms and/or signs of current or past CHF or
. NT-proBNP level >200 pg/mL in sinus rhythm or >600 pg/mL in AF/AT,
. E/é >13 at rest by tissue Doppler,
Disqualifiers
1. Current participation in a randomized clinical trial; 2. Confirmed or suspected diagnosis of an alternative or comorbid condition that, in the opinion of the investigator, may explain the patient's symptoms and signs of CHF; 3. History of heart transplantation, combined congenital heart disease, or the presence of a mechanical circulatory support device; 4. Cardiac tamponade; 5. Pregnancy and lactation, planning a pregnancy in the next 24 months; 6. Acute cerebrovascular accident, transient ischemic attack, acute coronary syndrome, or coronary revascularization within less than 30 days prior to or on the day of study inclusion; 7. Acute dysfunction or failure of one or more internal organs within 3 months prior to or on the day of inclusion; 8. Any cardiac surgery performed within 3 months prior to enrollment or planned within the next 6 months, including implantation of intracardiac devices, ablation for cardiac arrhythmias, or correction of valvular pathology; 9. Severe cognitive impairment or other conditions that, in the opinion of the investigator, prevent the patient from understanding the program, providing informed consent, or interfere with participation in the study; 10. Active cancer; 11. Verified cardiac amyloidosis or other infiltrative cardiomyopathy (hemochromatosis, Fabry disease, Gaucher disease); 12. Verified hereditary cardiomyopathy; 13. Heart disease due to reversible causes (e.g., Takotsubo syndrome).
Trial population
The study will include patients with pre-existing or clinically evident CHF at the outpatient stage or in hospital, provided that their condition is stabilized and there has been no intravenous therapy with diuretics, nitrates, vasopressors or inotropes during the previous 24 hours.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
the proportion of patients with the presence ofCardio-Kidney-Metabolic (CKM) Syndrome its components and their combinations
Time frame
From date of enrollment until the date of first documented progression assessed up to 24 months2
the proportion of patients with the presence ofCardio-Kidney-Metabolic (CKM) Syndrome its components and their combinations
the frequency of occurrence, associations and prognostic value of Cardio-Kidney-Metabolic (CKM) Syndrome and its components (CKD, T2DM, ASCVD and MAFLD) in patients with different phenotypes (hereinafter phenotypes - CHF with reduced, moderately reduced and preserved LVEF) and severity of clinical manifestations of CHF (hereinafter severity of clinical manifestations of CHF - pre-CHF, functional class (FC) I-II and III-IV).
Time frame
From date of enrollment until the date of first documented occurrence assessed up to 24 monthsSecondary outcomes
1
the proportion of patients developing adverse outcomes after 6, 12 and 24 months of follow-up
Determine the proportion of patients developing adverse outcomes after 6, 12, and 24 months of follow-up: * cardiovascular death, * hospitalization due to decompensated CHF, * total number of episodes of CHF worsening, including hospitalizations due to decompensated CHF and outpatient worsening of CHF, * death from any cause, * death from any cause or hospitalization due to decompensated CHF, * hospitalization for any cause, * any major cardiovascular event (including cardiovascular death, hospitalization due to decompensated CHF, acute myocardial infarction, unplanned revascularization, new-onset atrial fibrillation (AF), device implantation (cardioverter-defibrillator, pacemaker, cardiac resynchronization therapy device), unplanned cardiac surgery valves, acute cerebrovascular accident, revascularization of the carotid or peripheral arteries);
Time frame
From date of enrollment until the date of first documented cardiovascular death, • hospitalization due to decompensated CHF, • total number of episodes of CHF worsening, including hospitalizations due to , whichever came first, assessed up to 24 months"2
frequency of transition from pre-CHF to clinically expressed CHF
frequency of transition from pre-CHF to clinically expressed CHF depending on the initial signs of systolic or diastolic dysfunction of the left ventricle, the initial presence of 1, 2, 3 or 4 components of the CRGM, the therapy being administered
Time frame
From the enrollment to the documented clinically expressed CHF assessed up to 24 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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