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Anti-inflammatory agent

LoDoCo for Heart Failure

Phase 2

Recruiting

Led By Ambarish Pandey, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HF hospitalization or urgent/unplanned visit with a primary diagnosis of decompensated heart failure 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

Ambulatory participants who can perform cardiopulmonary exercise testing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial will study the effects of LoDoCo on exercise capacity, physical function, frailty & quality of life in heart failure patients with systemic inflammation. Participants will be randomly assigned to LoDoCo or placebo & complete physical exams & surveys over 3 months.

Who is the study for?

This trial is for people over 50 with heart failure (HFpEF) and inflammation, who've been diagnosed within the last 6 months. They must have had a recent heart failure episode and be able to do exercise tests. Participants should not be pregnant, planning pregnancy, or have severe kidney issues or liver enzymes more than 2.5 times the normal limit.Check my eligibility

What is being tested?

The study is testing if Low Dose Colchicine (LoDoCo) can improve exercise ability and quality of life in patients with HFpEF and inflammation compared to a placebo. It's randomized, meaning participants are put into either the LoDoCo group or placebo group by chance.See study design

What are the potential side effects?

Since LoDoCo isn't FDA-approved for this use yet, potential side effects aren't fully known but may include digestive issues like diarrhea or nausea since these are common with colchicine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was hospitalized or had an urgent visit for heart failure in the last 9 months and my NT-proBNP level is above 125 pg/mL.

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I can do a heart and lung fitness test.

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My weight loss medication dose has been stable.

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I am 50 years old or older.

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I was diagnosed with chronic heart failure with preserved ejection fraction within the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Peak VO2 indexed to body weight

Secondary outcome measures

Difference in 6 minute walk distance

Difference in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ) Score

Difference in hs-CRP levels

+1 more

Side effects data

From 2021 Phase 4 trial • 280 Patients • NCT01709981

Chest pain

Ischemic stroke

100%

80%

60%

40%

20%

Study treatment Arm

Colchicine

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Low dose colchicineExperimental Treatment1 Intervention

Low dose colchicine 0.5 mg once a day orally for 3 months

Group II: PlaceboPlacebo Group1 Intervention

Placebo once a day orally for 3 months

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,675 Total Patients Enrolled

Ambarish Pandey, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current regulation status of low dose colchicine by the FDA?

"Our team at Power believes that Low dose colchicine is relatively safe, and assigned it a score of 2. This decision was based on the fact that this trial has progressed to Phase 2, suggesting limited evidence of effectiveness but some data regarding safety."

Answered by AI

Are there openings available for enrolment in this trial?

"Per information provided on clinicaltrials.gov, this experiment is no longer seeking patients. The study was first posted in March of 2024 and last amended November 11th 2023; nevertheless, there are currently 1,136 other trials actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Ambarish Pandey 2024. "Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06130059.