Nutrition and Exercise for Pulmonary Arterial Hypertension

Palo Alto (17 mi)

Overseen byRaed Dweik

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: The Cleveland Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-75 with Group 1 Pulmonary Arterial Hypertension (PAH), including various subtypes, who are stable on current medications. It's not suitable for those with severe PAH symptoms, diabetes, heart issues like ischemia or uncontrolled arrhythmias, high oxygen needs (>4 LPM), recent fainting episodes, or other specific lung and systemic diseases.

Inclusion Criteria

My heart condition mildly or moderately affects my daily activities.

I am between 18 and 75 years old.

I have been on a stable dose of PAH treatment for at least 2 months.

Exclusion Criteria

I have high blood pressure in my lungs caused by lung disease and low oxygen levels.

I need more than 4 liters per minute of oxygen.

I have high blood pressure in my lungs due to a blood disorder or sarcoidosis.

My heart cannot pump blood properly on the right side.

I have Type 2 Diabetes.

I have high blood pressure in my lungs caused by heart disease.

I have been diagnosed with chronic blood clot-related lung high blood pressure.

I do not have heart rhythm problems, except for controlled atrial fibrillation or flutter.

I have high blood pressure in the veins of my liver.

Treatment Details

The PHINE study is testing whether a special diet and exercise program can improve the health of people with PAH by helping their bodies use insulin better. The idea is that changing how the body handles sugar might help ease the strain on blood vessels in the lungs.

2Treatment groups

Experimental Treatment

Active Control

Group I: Nutrition and ExerciseExperimental Treatment1 Intervention

5 days a week of moderate exercise and biweekly diet counseling on Low Glycemic Index/ Mediterranean Diet for 12 weeks.

Group II: Standard of CareActive Control1 Intervention

Counseling at baseline on diet as recommended by USDA and on the benefits of regular aerobic exercise.