NCT05637398CompletedPhase 1/2
Colchicine in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
Heart failure with preserved left ventricular ejection fraction (HFpEF) is a syndrome associated with high morbidity and mortality rates. Systemic low-grade inflammation is acknowledged to be a fundamental pathophysiological mechanism of HFpEF. Interventions targeting inflammatory pathway is understudied in HFpEF. Colchicine is a safe and well tolerated anti-inflammatory drug, which interferes with several steps in the inflammatory process. The drug has been extensively studied in different cardiovascular pathologies except HFpEF. We assume that colchicine decreases inflammation and reduces sST2 levels in HFpEF.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 5 Nov 2022
- Start date
- 15 Dec 2022
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Diseases
- Heart failure
- NCT number
- NCT05637398
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 42
- From 15 Dec 2022 to the primary completion date, 1 Sept 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hypertrophic cardiomyopathy, constrictive pericarditis, or cardiac amyloidosis
- Valvular heart disease
- Acute myocardial infarction in the last 3 months, cardiac surgery or cerebrovascular accident within the recent 6 months
- Any active or chronic inflammatory diseases or infections
- Patients with indication for colchicine therapy or history of colchicine intolerance
- Severe nervous system diseases
- History of any malignancy or suffering from cancer
Lab values
- Prior history of LVEF below 50%
Other
- Acute decompensation of HF in the last 1 month
- Severe hepatic (alanine aminotransferase N3 upper limit of normal or renal dysfunction (estimated glomerular filtration rate \<45 mL/min per 1.73m2)
- Lack of informed consent
Who the study is looking for
- 40 years of age, male and female
- Left ventricular ejection fraction (LVEF) ≥ 50%
- Symptoms and signs of heart failure
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥300 pg/ml at baseline (patients in atrial fibrillation at baseline NT-proBNP ≥ 600 pg/ml), left atrial volume index (LAVI) \>34 mL/m2 or a left ventricular mass index (LVMI) =115 g/m2 for males and =95 g/m2 for females
- body mass index (BMI) \> 30kg/m2 or diabetes mellitus
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| A Shchendrygina Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Anastasia Shchendrygina Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.