Status:
ACTIVE_NOT_RECRUITING
Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Pulmonary Arterial Hypertension
Insulin Resistance
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the extent to which diet and exercise may improve PAH through the modulation of insulin sensitivity. The central hypothesis is that dysregulated glucose met...
Detailed Description
Pulmonary arterial hypertension (PAH) leads to premature death as a consequence of increased pulmonary vascular resistance and right heart failure. PAH-targeted therapies developed over the past 20 ye...
Eligibility Criteria
Inclusion
- Age range between 18-75 years old
- Group 1 PAH, including idiopathic, heritable, drugs and toxin induced, and PAH associated with connective tissue disease, HIV infection and congenital heart disease
- NYHA Class II or III
- ≥ 1 PAH-targeted therapy with a stable dose for ≥ 2 months
- Stable dose of diuretics and rate of supplemental oxygen for the preceding 2 months
Exclusion
- Decompensated Right Heart Failure
- NYHA Class IV
- Syncope within the previous 3 months
- Cardiac Arrhythmia (except for controlled atrial fibrillation or flutter)
- Baseline supplemental O2 \> 4 LPM
- Portal Hypertension
- Pulmonary hypertension due to Lung Disease and Hypoxia
- Pulmonary Hypertension due to Left Heart Disease
- Chronic Thromboembolic Pulmonary Hypertension
- Pulmonary Hypertension associated with systemic diseases such as hematological disorders and sarcoidosis
- Type 2 Diabetes
- Evidence of cardiac ischemia on a graded exercise test
Key Trial Info
Start Date :
September 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03288025
Start Date
September 27 2017
End Date
June 30 2026
Last Update
September 24 2025
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195