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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with PAH due to unknown causes, genetics, or exposure to drugs/toxins.
Select...
My heart condition allows me to perform daily activities with little to no difficulty.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in six minute walk distance (meters)
Change from baseline to week 12 in World Health Organization Functional Class (WHO FC)
Secondary outcome measures
Change from Baseline to week 12 in Daily Step Count Goal Attainment, as measured by the percentage (%) of subjects who meet their daily step count goal
Change from baseline in Estimated Right Ventricle (RV) and Right Atrial (RA) Pressure, as assessed by echocardiogram results, expressed in mmHg
Cerebral Ventricles
+34 more

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 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.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicOTHER
1,034 Previous Clinical Trials
1,365,343 Total Patients Enrolled
7 Trials studying Pulmonary Arterial Hypertension
1,308 Patients Enrolled for Pulmonary Arterial Hypertension
Vanderbilt University Medical CenterLead Sponsor
865 Previous Clinical Trials
672,466 Total Patients Enrolled
10 Trials studying Pulmonary Arterial Hypertension
2,413 Patients Enrolled for Pulmonary Arterial Hypertension
Mayo ClinicOTHER
3,242 Previous Clinical Trials
3,773,667 Total Patients Enrolled
13 Trials studying Pulmonary Arterial Hypertension
1,606 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

Metformin (Biguanides) Clinical Trial Eligibility Overview. Trial Name: NCT03617458 — Phase 2
Pulmonary Arterial Hypertension Research Study Groups: Metformin + mHealth Intervention, Placebo + mHealth Intervention, Placebo + Usual Care, Metformin + Usual Care
Pulmonary Arterial Hypertension Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT03617458 — Phase 2
Metformin (Biguanides) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03617458 — Phase 2
~12 spots leftby Jun 2025
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