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

Official title

Multicenter Observational Prospective Study of Cardio-reno- Hepato -Metabolic Disease in Chronic Heart Failure

Overview

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.

Detailed description

The CARMEN-CHF study is a multicenter, observational, prospective study of the KRGMB in patients with pre-onset CHF or clinically overt CHF.

Patients who meet the study eligibility criteria and consent to participate must provide written informed consent prior to any study-related procedures. By signing the informed consent form, patients grant access to medical information for the purpose of verifying eligibility and collecting information during follow-up.

To ensure a representative sample, it is planned to enroll at least 3,000 patients at study centers across Russia. The proportion of patients included based on pre-onset CHF will be limited to 25% of the entire cohort.

The study's follow-up period is 24 months, during which four visits are planned: two telephone visits at 6 and 18 months, and two in-person visits at 12 and 24 months. If it is not possible to visit a doctor in person, it is permissible to collect information through telephone contacts with the patient or his relative or person caring for the patient.

Primary outcome measures

• 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 months]
• 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 occurrence assessed up to 24 months]

Secondary outcome measures (2)

• the proportion of patients developing adverse outcomes after 6, 12 and 24 months of follow-up [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"]
• frequency of transition from pre-CHF to clinically expressed CHF [Time frame: From the enrollment to the documented clinically expressed CHF assessed up to 24 months]

Eligibility criteria

Inclusion criteria

• 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). -

Exclusion criteria

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07380828 · RNST 01/26

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗