Nutrition and Exercise for Pulmonary Arterial Hypertension

Overseen by Gustavo Heresi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

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.

Research Team

Raed Dweik, MD

Principal Investigator

The Cleveland Clinic

Gustavo Heresi, MD

Principal Investigator

The Cleveland Clinic

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

I have Group 1 PAH, which may be related to a genetic condition, drug use, or another disease.

My diuretic dose and oxygen support have been stable for the last 2 months.

My heart condition mildly or moderately affects my daily activities.

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.

Treatment Details

Interventions

• Nutrition and Exercise (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Nutrition and Exercise Experimental Treatment 1 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 Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

David Peter

The Cleveland Clinic

Chief Medical Officer

MD, board-certified in Hospice and Palliative Medicine

Tomislav Mihaljevic

The Cleveland Clinic

Chief Executive Officer since 2018

MD from University of Zagreb School of Medicine

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco