RECRUITING

Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-24
Study Completion:2026-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06130059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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. 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:
  1. * 1. Do not otherwise meet the inclusion criteria. 2. Women who are pregnant, breastfeeding, or may be considering pregnancy during the study period.
  2. 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

Contacts and Locations

Study Contact

Ambarish Pandey, MD
CONTACT
2146459762
ambarish.pandey@utsouthwestern.edu

Principal Investigator

Ambarish Pandey, MD
PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75235
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Ambarish Pandey, MD, PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-24
Study Completion Date2026-01-31

Study Record Updates

Study Start Date2024-04-24
Study Completion Date2026-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure
  • Inflammation