Using low dose colchicine to improve exercise capacity in heart failure patients with inflammation

Pilot Study to Evaluate the Efficacy of Low Dose Colchicine (LoDoCo ®) to Improve Exercise Capacity Among Patients With Chronic Stable HFpEF and Systemic Inflammation

This study is testing if a low dose of colchicine can help people with heart failure feel better and exercise more easily.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (other)
• Drugs / interventions: cart
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT06130059 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of low dose colchicine (LoDoCo) in enhancing exercise capacity, physical function, frailty, and quality of life in patients diagnosed with heart failure with preserved ejection fraction (HFpEF) and systemic inflammation. Participants will be screened and, if eligible, will be randomized to receive either LoDoCo or a placebo for a duration of three months. The study will assess various outcomes, including VO2peak, 6-minute walk distance, Kansas City Cardiomyopathy Questionnaire scores, and changes in heart structure and function. The trial is being conducted at the UT Southwestern HFpEF program, which integrates clinical care and research for patients with this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 50 and above with a diagnosis of chronic HFpEF and elevated serum hs-CRP levels.

Not a fit: Patients without chronic HFpEF or those with normal hs-CRP levels may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved exercise capacity and quality of life for patients suffering from HFpEF and inflammation.

How similar studies have performed: While the use of colchicine in other contexts has shown promise, this specific application in HFpEF is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Dallas, Texas

• UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Ambarish Pandey, MD — University of Texas Southwestern Medical Center
• Study coordinator: Ambarish Pandey, MD

Conditions: Heart Failure, Inflammation