Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Collaborators: Mayo Clinic; The Cleveland Clinic
• Treatments: Metformin

Criteria

Inclusion Criteria:• Adults aged 18 or older.

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

• Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.

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

• WHO Functional Class I-III

• Ambulatory

Exclusion Criteria:

• Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity

• Pregnancy

• Diagnosis of PAH etiology other than idiopathic, heritable, or associated with drugs or toxins

• FEV1> or = 65% predicted AND normal chest imaging

• WHO Functional class IV heart failure

• Requirement of > 1 diuretic adjustment in the prior 30 days

• Preferred form of activity is not measured by an activity tracker (swimming, ice skating, stair master, or activities on wheels such as bicycling or rollerblading)

• Type I diabetes mellitus

• Prior diagnosis of cirrhosis

• Untreated hypo- or hyper-thyroidism

• estimated glomerular filtration rate (eGFR) by modification of diet in renal disease (MDRD) <60 milliliters per minute (mL/min)