CArdio-Reno- Hepato -MEtabolic Disease iN Chronic Heart Failure (CARMEN-CHF)

Starting soon

Conditions studied: Heart Failure, Cardio-renal-metabolic Syndrome

In brief

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.

Key facts

Study ID

NCT07380828

Run by

Russian Scientific Medical Society of Therapists

People needed

3000

Starts

2026-02-01

Expected to finish

2029-05-01

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years;
• A diagnosis that satisfies one of the following criteria:
• At least one of the following:
• LVEF <50%, LV longitudinal systolic strain (GLS) <18%, NT-proBNP >125 pg/mL in sinus rhythm or 365 in AF/AT, E/é >9 at rest by tissue Doppler, Indexed left ventricular volume (ILV) >34 mL/m2 in sinus rhythm or 40 mL/m2 in AF/AT, Tricuspid regurgitation (TR) velocity >2.8 m/s or pulmonary artery systolic pressure (PASP) >35 mmHg. at rest, Left ventricular myocardial mass index (LVMI) >115/95 g/m2 in men/women and relative wall thickness (RWT) >0.42, in the absence of symptoms and/or signs of current or past CHF, which corresponds to "pre-CHF" in accordance with the 2024 clinical guidelines.
• or
• LVEF <50% and the presence of symptoms and/or signs of current or past CHF or
• LVEF ≥50% and the presence of symptoms and/or signs of current or past CHF, as well as at least one of the following (A, B, C) criteria:
• A. Presence of one of the signs of structural and/or functional heart disorders consistent with the presence of diastolic dysfunction / elevated left ventricular filling pressure:
• . NT-proBNP level >200 pg/mL in sinus rhythm or >600 pg/mL in AF/AT,
• . E/é >13 at rest by tissue Doppler,
• . 13 ≥E/é >9 + left atrial dilation (LAD) >34 ml/m2 in sinus rhythm or >40 ml/m2 in AF/AT,
• . 13 ≥E/é >9 + TR velocity >2.8 m/s or PASP >35 mmHg at rest,
• . 13 ≥E/é >9 + presence of left ventricular hypertrophy, defined as LVMI >115 g/m2 in men and >95 g/m2 in women, WCT >0.42, OR B. Presence of 7-9 points on the H2FPEF scale; OR C. Positive diastolic stress test result confirming increased LV filling pressure (E/e'≥15, TR velocity >3.4 m/s) 3. No intravenous therapy with diuretics, nitrates, vasopressors, or inotropes within 24 hours prior to inclusion; 4. Availability of results of all of the following tests, performed no earlier than in the previous 6 months prior to inclusion in the study:
• [1] Complete blood count with hemoglobin and platelet levels, [2] Blood chemistry with total bilirubin, ALT, and AST levels, [3] Serum uric acid and creatinine levels, with glomerular filtration rate (eGFR) calculation using the 2021 CKD-EPI formula, [4] Fasting glucose and HbA1c, and, if the diagnosis is uncertain, an oral glucose tolerance test, [5] Ultrasound of the carotid and/or femoral arteries (only in patients with no prior history of atherosclerotic cardiovascular disease), [6] Urine test for CKD markers - at least one of the following: daily albuminuria (mg/day) and/or albumin/creatinine ratio in a single urine portion (mg/g or mg/mmol) and/or daily proteinuria (g/day) and/or protein/creatinine ratio in a single urine portion (mg/g or mg/mmol). -

You may not qualify if…

• 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).

Full record on ClinicalTrials.gov

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