Metformin + mHealth for Pulmonary Arterial Hypertension
What You Need to Know Before You Apply
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).
Will I have to stop taking my current medications?
The trial requires that your PAH-specific medication regimen be stable for three months before joining, so you should not stop taking those medications. However, if you have had only one diuretic adjustment in the past three months, you can still participate.
How is the drug Metformin unique for treating pulmonary arterial hypertension?
Metformin is unique for treating pulmonary arterial hypertension because it is traditionally used to manage diabetes by improving insulin sensitivity, and its use in this context is novel, potentially offering a new mechanism of action compared to existing treatments that focus on other pathways.12345
What data supports the effectiveness of the drug Metformin for Pulmonary Arterial Hypertension?
Who Is on the Research Team?
Anna R Hemnes, MD
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive metformin or placebo and engage in mHealth intervention or usual care for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Metformin
- mHealth Intervention
- Placebo
- Usual Care
Metformin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
The Cleveland Clinic
Collaborator
Mayo Clinic
Collaborator