Pilot Study to Evaluate the Efficacy of Low Dose Colchicine (LoDoCo ®) to Improve Exercise Capacity Among Patients With Chronic Stable HFpEF and Systemic Inflammation
Low Dose Colchicine
+ Placebo
Cardiovascular Diseases+3
+ Heart Diseases
+ Heart Failure
Treatment Study
Summary
Study start date: April 24, 2024
Actual date on which the first participant was enrolled.This study aims to explore whether low-dose Colchicine, a medication known as LoDoCo, can help improve exercise capacity in people with a specific type of heart failure called HFpEF (Heart Failure with preserved Ejection Fraction) who also have systemic inflammation. Participants will be recruited from a specialized heart failure program in Texas, focusing on those with chronic stable HFpEF. The goal is to see if this treatment can enhance their ability to exercise, which is often limited in such patients. Improving exercise capacity is important as it can lead to better overall heart health and quality of life for those affected by this condition. Participants in the study will be randomly assigned to receive either the LoDoCo treatment or a placebo, ensuring that neither they nor the researchers know which one they are receiving, to keep the results unbiased. The study will last for three months, during which participants will undergo a variety of tests and assessments. These include blood tests, heart ultrasound scans (echocardiography), and exercise tests to measure how well their heart and lungs work during physical activity. The main focus is on the peak oxygen uptake during exercise, an important indicator of exercise capacity. Other assessments include walking distance tests and questionnaires about health-related quality of life. These measures will help determine if LoDoCo provides real benefits in improving heart function and reducing inflammation-related limitations.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
UT Southwestern Medical Center
Dallas, United StatesOpen UT Southwestern Medical Center in Google Maps