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Nutrition and Exercise for Pulmonary Arterial Hypertension

N/A

Waitlist Available

Led By Raed Dweik

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

NYHA Class II or III

Age range between 18-75 years old

Must not have

Pulmonary hypertension due to Lung Disease and Hypoxia

Baseline supplemental O2 > 4 LPM

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Summary

This trial will test whether diet and exercise can help improve Pulmonary Arterial Hypertension by affecting insulin sensitivity.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While this trial focuses on nutrition and exercise which typically have positive effects on health, potential side effects may include muscle soreness from physical activity and changes in digestion or appetite due to new dietary habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart condition mildly or moderately affects my daily activities.

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I am between 18 and 75 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I need more than 4 liters per minute of oxygen.

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

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My heart cannot pump blood properly on the right side.

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I have Type 2 Diabetes.

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

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insulin Sensitivity

Secondary study objectives

Right Ventricular Global Peak Longitudinal Strain

Trial Design

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.

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,045 Previous Clinical Trials

1,370,641 Total Patients Enrolled

7 Trials studying Pulmonary Arterial Hypertension

1,356 Patients Enrolled for Pulmonary Arterial Hypertension

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,889 Previous Clinical Trials

47,834,173 Total Patients Enrolled

27 Trials studying Pulmonary Arterial Hypertension

3,197 Patients Enrolled for Pulmonary Arterial Hypertension

Raed DweikPrincipal InvestigatorThe Cleveland Clinic

Media Library

Nutrition and Exercise Clinical Trial Eligibility Overview. Trial Name: NCT03288025 — N/A

Pulmonary Arterial Hypertension Research Study Groups: Nutrition and Exercise, Standard of Care

Pulmonary Arterial Hypertension Clinical Trial 2023: Nutrition and Exercise Highlights & Side Effects. Trial Name: NCT03288025 — N/A

Nutrition and Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT03288025 — N/A

~4 spots leftby Sep 2025

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