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NCT06130059 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Heart Failure and Inflammation, sponsored by University of Texas Southwestern Medical Center.

Recruiting
Registry status
Phase 2
Development phase
60
Enrollment target
1
Study location

NCT06130059 is a Phase 2 study of Heart Failure and Inflammation that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 60 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06130059, a Phase 2 study of Heart Failure and Inflammation, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.

RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
1
Study location

Study 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 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.

Interventions

  • DRUG Placebo
  • DRUG Low Dose Colchicine

Study Locations (1)

Texas

  • UT Southwestern Medical Center - Dallas

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2024-04-24
Est. Completion 2027-12-31
Phase Phase 2

What the Registry Record Tells You About NCT06130059

The ClinicalTrials.gov registry entry for NCT06130059 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06130059 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT06130059 about?

NCT06130059 is a clinical study titled "Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation". 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....

What is the current status of trial NCT06130059?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-04-24. Estimated completion is 2027-12-31.

What conditions does trial NCT06130059 study?

This clinical trial studies the following conditions: Heart Failure, Inflammation.

What interventions are being tested in trial NCT06130059?

The interventions under investigation include: Placebo (DRUG), Low Dose Colchicine (DRUG).

Who is sponsoring clinical trial NCT06130059?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06130059 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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