Colchicine in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
A Shchendrygina
RECRUITING
Moscow
Anastasia Shchendrygina
RECRUITING
Moscow
Contact Information
Primary
Anastasia SHCHENDRYGINA
a.shchendrygina@gmail.com
+79262309207
Backup
Svetlana Rachina
rachina_s_a@staff.sechenov.ru
Time Frame
Start Date: 2022-12-15
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 40
Treatments
Active_comparator: Colchicine 0.5 bid
Eligible HFpEF patients will be randomized in 1:1 ratio by an investigator with either colchicine 0.5 twice daily or usual care for 12 weeks
No_intervention: Usual Care
Eligible HFpEF patients will be randomized in 1:1 ratio by an investigator with either colchicine 0.5 twice daily or usual care for 12 weeks
Sponsors
Leads: I.M. Sechenov First Moscow State Medical University

This content was sourced from clinicaltrials.gov