Status:
RECRUITING
Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Heart Failure
Inflammation
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
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 w...
Detailed Description
The investigators propose a single-center, double-blind placebo-controlled pilot study of LoDoCo vs. matching placebo among patients with chronic stable HFpEF and systemic inflammation. Patients that ...
Eligibility Criteria
Inclusion
- 1\. Informed consent was obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- 2\. Age 50 years or above at the time of signing the informed consent. 3. Serum hs-CRP 2 mg/L at the time of baseline testing. 4. Diagnosis of chronic HFpEF within 6 months of enrolment must have one of the following:
- a. Structural Heart Disease with one of the following on echocardiography within 12 months of enrolment.
- i. LA volume index \> 34 ml/m2. ii. LA diameter ≥ 3.8 cm. iii. LA length ≥ 5.0 cm. iv. LA area ≥ 20 cm2. v. LA volume ≥ 55 mL. vi. Intraventricular septal thickness ≥1.1 cm. vii. Posterior wall thickness ≥1.1 cm. viii. LV mass index ≥115 g∕m2 in men or ≥ 95 g∕m2 in women. ix. E/e' (mean septal and lateral) ≥ 10. x. e' (mean septal and lateral) \< 9 cm/s b. Pulmonary capillary wedge pressure (PCWP) at rest³15 mmHg or Left ventricular end-diastolic pressure (LVEDP) ³18 mmHg, (PCWP) with exercise ³25 mmHg or (³ 2 mmHg/L/min) c. HF hospitalization or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous loop diuretic treatment, within the last 9 months prior to enrolment in combination with NT-proBNP ≥ 125 pg/mL within 1 month of enrolment for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening NT-proBNP must be ≥ 300 pg/mL 5. Ambulatory participants who can perform cardiopulmonary exercise testing. 6. Stable doses of HF-specific medications within the last 1 month. 7. Stable level of physical activity 8. Stable dose of any weight loss medications.
Exclusion
- 1\. Do not otherwise meet the inclusion criteria. 2. Women who are pregnant, breastfeeding, or may be considering pregnancy during the study period.
- 3\. Renal impairment: eGFR \<30mL/min 4. Severe valvular heart disease is considered likely to require intervention. 5. Life expectancy \<1 year. 6. Unable to perform cardiopulmonary exercise testing. 7. ALT or AST \>2.5 ULN at time of screening
Key Trial Info
Start Date :
April 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06130059
Start Date
April 24 2024
End Date
January 31 2026
Last Update
April 25 2025
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75235