Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-002180
Sponsor Protocol Number: 180198
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, scleroderma, or drug- or toxin-associated pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.
- Repaired simple congenital heart disease or unrepaired ASD.
- 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.
- FEV1 > or = 60% predicted and no more than mild abnormalities on lung imaging.
- 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.
- Drug and toxin associated PAH patients with active drug use.
- WHO Functional class IV heart failure.
- 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 < 40mL/min.
Eligibility last updated 1/7/22. Questions regarding updates should be directed to the study team contact.
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Robert Frantz, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available