Actively Recruiting
Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation
Led by University of Texas Southwestern Medical Center · Updated on 2026-02-27
60
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research study is to determine the effectiveness of low dose colchicine (LoDoCo) on measures of exercise capacity, physical function, frailty, and quality of life, among patients with heart failure with chronic stable preserved ejection fraction (HFpEF) and systemic inflammation. The use of LoDoCo in this study is considered investigational as it has not been approved by the Food and Drug Administration (FDA) for the treatment of exercise capacity in patients with HFpEF. Participants will undergo a 1-day screening that includes a blood draw and physical examination. If deemed eligible for the study, participants will undergo a baseline visit within 2 weeks of screening visit that includes physical examination, exercise testing, echocardiography and completion of quality-of-life surveys. Participants will also be randomized at this visit (randomly assigned to a group) to receive either LoDoCo or placebo (inactive substance) for 3 months. Participants will be called back at 3 months for repeat physical examination, blood draws, echocardiography, exercise testing and completion of quality-of-life surveys. Each visit will take about 3 hours. Total study duration is about 3 months.
CONDITIONS
Official Title
Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent obtained before any study-related activities
- Age 50 years or older at time of consent
- Serum hs-CRP of 2 mg/L or higher at baseline testing
- Diagnosis of chronic stable HFpEF within 6 months with specified echocardiographic or hemodynamic criteria
- Ambulatory and able to perform cardiopulmonary exercise testing
- Stable doses of heart failure medications for at least 1 month
- Stable level of physical activity
- Stable dose of any weight loss medications
You will not qualify if you...
- Do not meet the inclusion criteria
- Women who are pregnant, breastfeeding, or may consider pregnancy during study
- Renal impairment with eGFR less than 30 mL/min
- Severe valvular heart disease likely requiring intervention
- Life expectancy less than 1 year
- Unable to perform cardiopulmonary exercise testing
- ALT or AST liver enzymes greater than 2.5 times the upper limit of normal at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
Research Team
A
Ambarish Pandey, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here