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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

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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.

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

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicOTHER

1,026 Previous Clinical Trials

1,365,994 Total Patients Enrolled

7 Trials studying Pulmonary Arterial Hypertension

1,308 Patients Enrolled for Pulmonary Arterial Hypertension

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

672,110 Total Patients Enrolled

10 Trials studying Pulmonary Arterial Hypertension

2,413 Patients Enrolled for Pulmonary Arterial Hypertension

Mayo ClinicOTHER

3,206 Previous Clinical Trials

3,767,001 Total Patients Enrolled

12 Trials studying Pulmonary Arterial Hypertension

1,595 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

Frequently Asked Questions

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

Is the Metformin and mHealth Intervention combination a risk-free solution for patients?

"Despite no previous evidence of efficacy, the safety profile of Metformin + mHealth Intervention was rated a 2 due to some existing data indicating its security."

Answered by AI

What objectives is this research endeavor attempting to accomplish?

"This clinical trial seeks to measure the efficacy of mHealth intervention or metformin in improving six minute walking distance and daily step count over a 12 week period. Secondary outcomes include an assessment of differences in participant characteristics including demographic information, current medication regimen, physical exam results, echocardiogram readings and laboratory values at baseline compared with those taken after completion of the treatment. Plasma Brain Natriuretic Peptide (BNP) will also be measured as it is a marker for myocardial stress which decreases with exercise training."

Answered by AI

Is admission for participants currently available in this research program?

"According to clinicaltrials.gov, this research is still open for recruitment and has been regularly updated since it was first posted on August 23rd 2018. The most recent update occurred on June 27th 2022."

Answered by AI

Has Metformin been combined with mobile health tools in past studies?

"Currently, 170 clinical trials studying the Metformin + mHealth Intervention are in operation. 43 of these investigations have progressed to Phase 3 and most them originate from Pittsburgh, Pennsylvania; though 1903 other medical sites are also conducting research into this therapy."

Answered by AI

To what extent is participation in this medical experiment limited?

"Affirmative, the clinical trial remains open for enrollment. According to the data hosted on clinicialtrials.gov, this medical investigation was first posted on August 23rd 2018 and most recently updated on June 27th 2022; it is currently seeking 130 participants at a single location."

Answered by AI