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Biguanides

Metformin + mHealth for Pulmonary Arterial Hypertension

Phase 2

Waitlist Available

Led By Anna R Hemnes, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

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

Must have

Diagnosed with idiopathic, heritable, or drug- or toxin-associated pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations

WHO Functional Class I-III

Must not have

FEV1> or = 65% predicted AND normal chest imaging

Type I diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 weeks

Summary

This trial is testing two interventions to see if they can improve insulin resistance in people with pulmonary artery hypertension. The primary endpoint is a 10% improvement in the distance the person can walk in six minutes, or an improvement in the person's functional class according to the World Health Organization.

Who is the study for?

This trial is for adults over 18 with pulmonary arterial hypertension (PAH) who are able to walk and have been on a stable PAH medication regimen. They must own a smartphone with Bluetooth and data plan. Excluded are those with severe liver disease, untreated thyroid issues, certain physical limitations, pregnancy, poor kidney function, specific lung function criteria or type I diabetes.

What is being tested?

The study tests if Metformin or an mHealth intervention can improve walking distance by 10% or WHO functional class in PAH patients compared to placebo/usual care. Participants will be randomly assigned to one of the interventions.

What are the potential side effects?

Metformin may cause digestive upset, weakness, muscle pain; while mHealth has no direct side effects but could lead to privacy concerns due to data sharing.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with PAH due to unknown causes, genetics, or exposure to drugs/toxins.

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My heart condition allows me to perform daily activities with little to no difficulty.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lung function is good and my chest scans are normal.

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I have Type I diabetes.

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My kidney function is reduced, with an eGFR below 60 mL/min.

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I have untreated thyroid issues.

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I have been diagnosed with cirrhosis before.

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I am unable to do normal activities because I use a wheelchair, walker, or have severe pain.

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My PAH is not caused by genetics, drugs, or toxins.

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I've had my water pill dosage changed more than once in the last month.

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I have severe heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Six Minute Walk Distance (Meters)

Change From Baseline to Week 12 in World Health Organization Functional Class (WHO FC)

Secondary study objectives

Change From Baseline in Estimated Right Ventricle (RV) and Right Atrial (RA) Pressure, as Assessed by Echocardiogram Results, Expressed in mmHg

Change From Baseline in Right Ventricle (RV) Fractional Area, as Assessed by Echocardiogram Results, Expressed in Percentage (%).

Change From Baseline in Right Ventricle (RV) Free Wall Longitudinal Strain, as Assessed by Echocardiogram Results, and Expressed as Percent (%) Change in Myocardial Deformation.

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Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Metformin + mHealth InterventionActive Control2 Interventions

Patients will receive active ingredient medicine with mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue. Subjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po twice a day (BID) x 5 days, 500mg by mouth (po) three times a day (TID) x 5 days,1000mg po BID x 69 days (12 weeks total).

Group II: Metformin + Usual CareActive Control2 Interventions

Patient will receive active ingredient medicine with routine medical care. Subjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po BID x 5 days, 500mg po TID x 5 days,1000mg po BID x 69 days (12 weeks total).

Group III: Placebo + mHealth InterventionPlacebo Group2 Interventions

Patient will receive non active medicine and the mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.

Group IV: Placebo + Usual CarePlacebo Group2 Interventions

Patient will receive non active medicine and routine medical care.

0 / 11Eligibility criteria met