Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)
2 other identifiers
interventional
34
1 country
1
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 metabolism elicits a response in PAH patients that can be modified by exercise and diet, thereby leading to improvements in pulmonary vascular disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2017
CompletedFirst Posted
Study publicly available on registry
September 19, 2017
CompletedStudy Start
First participant enrolled
September 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedSeptember 24, 2025
September 1, 2025
4.4 years
August 31, 2017
September 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin Sensitivity
Assessed by the frequently-sampled intravenous glucose tolerance test. Units of assessment in min/uU\*mL
5 years
Secondary Outcomes (1)
Right Ventricular Global Peak Longitudinal Strain
5 years
Study Arms (2)
Nutrition and Exercise
EXPERIMENTAL5 days a week of moderate exercise and biweekly diet counseling on Low Glycemic Index/ Mediterranean Diet for 12 weeks.
Standard of Care
NO INTERVENTIONCounseling at baseline on diet as recommended by USDA and on the benefits of regular aerobic exercise.
Interventions
5 times a week exercise training and biweekly diet counseling for 12 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raed Dweik, MD
The Cleveland Clinic
- PRINCIPAL INVESTIGATOR
Gustavo Heresi, MD
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff, Pulmonary Medicine
Study Record Dates
First Submitted
August 31, 2017
First Posted
September 19, 2017
Study Start
September 27, 2017
Primary Completion
February 18, 2022
Study Completion (Estimated)
June 30, 2026
Last Updated
September 24, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share