Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension (NCT03617458) | Clinical Trial Compass
CompletedPhase 2
Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension
United States73 participantsStarted 2018-08-23
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 millili…
What they're measuring
1
Change From Baseline in Six Minute Walk Distance (Meters)
Timeframe: baseline and 12 weeks
2
Change From Baseline to Week 12 in World Health Organization Functional Class (WHO FC)