Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension

  • STATUS
    Recruiting
  • End date
    Dec 12, 2023
  • participants needed
    130
  • sponsor
    Vanderbilt University Medical Center
Updated on 12 July 2022
hypertension
diuretics
epoprostenol

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).

Description

The investigators propose to test the hypothesis that interventions to improve insulin resistance will improve exercise capacity and World Health Organization (WHO) functional class in PAH. The investigators propose three specific aims to test this 1) A prospective 2x2 factorial design 12-week clinical trial of metformin or placebo and activity intervention or usual care to assess effect on six minute walk and WHO functional class, 2) Assessment of the interventions in Aim 1 in a subset of patients on right ventricle (RV) and peripheral muscle function and lipid content and markers of pulmonary vascular disease to define how these interventions may work in PAH and 3) Identify and prospectively test peripheral blood markers of metformin response in PAH. The broad goals of this work are to demonstrate the efficacy and mechanisms of interventions against insulin resistance in PAH and to identify which patients are most likely to benefit from these interventions, moving to precision medicine in PAH.

The investigators are planning a factorial design trial. Patients will be randomized twice. The first is metformin or placebo and is quadruple randomized. The second is mobile health (mHealth) intervention via texts or standard of care and is not blinded to the patients, but is to the investigator and thus is triple randomized.

Details
Condition Pulmonary Artery Hypertension
Treatment Placebo, Metformin, Usual Care, mHealth Intervention
Clinical Study IdentifierNCT03617458
SponsorVanderbilt University Medical Center
Last Modified on12 July 2022

Eligibility

Yes No Not Sure

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)
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