CArdio-Reno- Hepato -MEtabolic Disease iN Chronic Heart Failure (CARMEN-CHF)
3,000 participantsStarted 2026-02
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years;
. A diagnosis that satisfies one of the following criteria:
. . 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the proportion of patients with the presence ofCardio-Kidney-Metabolic (CKM) Syndrome its components and their combinations
Timeframe: From date of enrollment until the date of first documented progression assessed up to 24 months
2
the proportion of patients with the presence ofCardio-Kidney-Metabolic (CKM) Syndrome its components and their combinations
Timeframe: From date of enrollment until the date of first documented occurrence assessed up to 24 months
Trial details
NCT IDNCT07380828
SponsorRussian Scientific Medical Society of Therapists