Metformin + mHealth for Pulmonary Arterial Hypertension

Overseen by Anna R Hemnes, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Vanderbilt University Medical Center

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to determine the impact of two interventions against insulin resistance on the composite endpoint of 10% improvement in baseline six minute walk distance or improvement in World Health Organization (WHO) functional class in humans with pulmonary artery hypertension (PAH).

Research Team

Anna R Hemnes, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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.

Inclusion Criteria

Subjects must own a Bluetooth capable modern smartphone capable of receiving and sending text messages and an active data plan

My PAH medication has been the same for the last 3 months, except for one diuretic change.

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

Exclusion Criteria

Pregnancy

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

I have Type I diabetes.

Treatment Details

Interventions

• Metformin (Biguanides)
• mHealth Intervention (Behavioural Intervention)
• Placebo (Drug)
• Usual Care (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Metformin + mHealth Intervention Active Control 2 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 Care Active Control 2 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 Intervention Placebo Group 2 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 Care Placebo Group 2 Interventions

Patient will receive non active medicine and routine medical care.

Metformin is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Glucophage for:

• Type 2 diabetes

Approved in Japan as Glucophage for:

• Type 2 diabetes

Approved in China as Glucophage for:

• Type 2 diabetes

Approved in Switzerland as Glucophage for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+