Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension

Overview

About this study

The primary purpose 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 WHO functional class.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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.
  • eGFR by MDRD < 50mL/min.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Frantz, M.D.

Open for enrollment

Contact information:

Louise Durst R.N.

(507) 284-1838

durst.louise@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available