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

NCT07380828 | Not Yet Recruiting DMC

• 1 other identifier: RNST 01/26
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Heart Failure; Cardio-renal-metabolic Syndrome

Keywords

obesity; atherosclerosis; type 2 diabetes mellitus; heart failure

Outcome Measures

Primary Outcomes (2)

• the proportion of patients with the presence ofCardio-Kidney-Metabolic (CKM) Syndrome its components and their combinations

  From date of enrollment until the date of first documented progression assessed up to 24 months

• 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).

  From date of enrollment until the date of first documented occurrence assessed up to 24 months

Secondary Outcomes (2)

• the proportion of patients developing adverse outcomes after 6, 12 and 24 months of follow-up

  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"

• frequency of transition from pre-CHF to clinically expressed CHF

  From the enrollment to the documented clinically expressed CHF assessed up to 24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

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.
• 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,
• ≥E/é \>9 + left atrial dilation (LAD) \>34 ml/m2 in sinus rhythm or \>40 ml/m2 in AF/AT,
• ≥E/é \>9 + TR velocity \>2.8 m/s or PASP \>35 mmHg at rest,
• \[1\] 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). -

Sponsors & Collaborators

• Russian Scientific Medical Society of Therapists: lead

MeSH Terms

Conditions

Heart Failure; Obesity; Atherosclerosis; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Oxana Drapkina, doctor of sciences

  National Medical Research Center for Terapy and Preventive Medicine

  STUDY CHAIR

• Anna Chesnikova, doctor of sciences

  Rostov-on-Don State Medical Univercity

  STUDY CHAIR

Central Study Contacts

Anjela E Soloveva, Phd

CONTACT

+7 915 376 6940; anzhela.solovieva@gmail.com

Alexandr Gorshkov, phd

CONTACT

+7 916 310 9184; agorshkov@gnicpm.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: February 2, 2026

Record last verified: 2026-01