Phase 2
Completed N=73
Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension
Pulmonary Artery Hypertension
Source: ClinicalTrials.gov NCT03617458 ↗
Enrolled (actual)
73
Serious AEs
13.7%
Results posted
Oct 2024
Primary outcomePrimary: Change From Baseline in Six Minute Walk Distance (Meters) — 414.5; 461.7; 448.9; 483.0 meters
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Six Minute Walk Distance (Meters) |
414.5; 461.7; 448.9; 483.0; 457.2; 474.9 | — |
| PRIMARY Change From Baseline to Week 12 in World Health Organization Functional Class (WHO FC) |
15; 12; 14; 13; 1; 2 | — |
| SECONDARY Change From Baseline to Week 12 in Body Weight (Kilograms) |
— | — |
| SECONDARY Change From Baseline to Week 12 in Body Mass Index (BMI) |
— | — |
| SECONDARY Change From Baseline to Week 12 in Absolute Six-Minute Walk Distance (Meters) |
— | — |
| SECONDARY Change From Baseline to Week 12 in Borg Dyspnea Score |
— | — |
| SECONDARY Change From Baseline to Week 12 in Emphasis-10 Quality of Life Survey Score |
— | — |
| SECONDARY Change From Baseline to Week 12 in Daily Step Count, as Measured by the Mean Daily Step Count |
— | — |
| SECONDARY Change From Baseline to Week 12 in Daily Step Count Goal Attainment, as Measured by the Percentage (%) of Subjects Who Meet Their Daily Step Count Goal |
— | — |
| SECONDARY Change From Baseline to Week 12 in Daily Aerobic Time (Minutes) |
— | — |
| SECONDARY Change From Baseline to Week 12 in Total Daily Activity Assessed in Step Counts Per Minute |
— | — |
| SECONDARY Change From Baseline to Week 12 in Resting Heart Rate (Beats Per Minute) |
— | — |
| SECONDARY Change From Baseline to Week 12 in Homeostatic Model Assessment (HOMA)-Insulin Resistance (IR) |
— | — |
| SECONDARY Number of Participants With Abnormal Laboratory Values of Plasma Estradiol Metabolites |
— | — |
| SECONDARY Number of Participants With Abnormal Laboratory Values of Urine Estradiol Metabolites |
— | — |
| SECONDARY Number of Participants With Abnormal Laboratory Values of Plasma Lipid Profile |
— | — |
| SECONDARY Number of Participants With Abnormal Laboratory Values of Plasma Free Fatty Acid Profiles |
— | — |
| SECONDARY Number of Participants With Abnormal Laboratory Values of Plasma Acylcarnitine Profiles |
— | — |
| SECONDARY Change From Baseline to Week 12 in Plasma Brain Natriuretic Peptide (BNP) Laboratory Value Measured in pg/ml |
— | — |
| SECONDARY Change From Baseline to Week 12 in Quadriceps Skeletal Muscle Triglyceride Content, as Measured by % Triglycerides |
— | — |
| SECONDARY Change From Baseline to Week 12 in Quadriceps Skeletal Muscle Fatigue, as Measured by Total Time to Muscle Fatigue During the Muscle Strength and Function Test |
— | — |
| SECONDARY Change From Baseline to Week 12 in Quadriceps Skeletal Muscle Strength During the Muscle Strength and Function Test, as Measured by Maximum Contraction Strength |
— | — |
| SECONDARY Change From Baseline to Week 12 in Quadriceps Skeletal Muscle Contractile Tissue Cross-sectional |
— | — |
| SECONDARY Change From Baseline to Week 12 in RV Myocardial Muscle Triglyceride Content, as Measured by % Triglycerides |
— | — |
| SECONDARY Change From Baseline to Week 12 in Tricuspid Annular Plane Systolic Excursion (TAPSE), Expressed in mm. |
— | — |
| SECONDARY Change From Baseline in Right Ventricle (RV) and Left Ventricle (LV) Ejection Fraction Values as Assessed by Echocardiogram Results, Expressed in Percentage (%). |
— | — |
| SECONDARY Change From Baseline in Right Ventricle (RV) Fractional Area, as Assessed by Echocardiogram Results, Expressed in Percentage (%). |
— | — |
| SECONDARY Change From Baseline in Tricuspid Annular Velocity (S'), as Assessed by Echocardiogram Results, Expressed in cm/Sec |
— | — |
| SECONDARY Change From Baseline in Tricuspid Regurgitant (TR) Velocity, as Assessed by Echocardiogram Results, Expressed in m/Sec. |
— | — |
| SECONDARY Change From Baseline in Estimated Right Ventricle (RV) and Right Atrial (RA) Pressure, as Assessed by Echocardiogram Results, Expressed in mmHg |
— | — |
| SECONDARY Change From Baseline in Right Ventricle (RV) and Left Ventricle (LV) Diastolic Function as Assessed by Doppler Inflow Patterns on Echocardiogram. |
— | — |
| SECONDARY Change From Baseline in Right Ventricle (RV) Free Wall Longitudinal Strain, as Assessed by Echocardiogram Results, and Expressed as Percent (%) Change in Myocardial Deformation. |
— | — |
| SECONDARY Number of Participants With a Change in Screening Clinical Characteristics |
— | — |
| SECONDARY Number of Patients With Treatment - Emergent Adverse Events (Safety and Tolerability of mHealth Intervention and Drug Treatment in PAH Subjects) |
— | — |
| SECONDARY Patient Satisfaction of Treatment Interventions, as Measured by Change in Emphasis-10 Survey Score |
— | — |
| SECONDARY Dropout Rate Incidence |
— | — |
| SECONDARY Number of Patients With a PAH-related Hospitalization Incidence |
— | — |
| SECONDARY Change From Baseline to Week 12 in Patient Medication Regimen, as Measured by Percentage (%) of Subjects With a Change in Medication Regimen |
— | — |
| SECONDARY Incidence of Death |
— | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT03617458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.