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Nutrition and Exercise for Pulmonary Arterial Hypertension

N/A
Waitlist Available
Led By Gustavo Heresi, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Group 1 PAH, including idiopathic, heritable, drugs and toxin induced, and PAH associated with connective tissue disease, HIV infection and congenital heart disease
Stable dose of diuretics and rate of supplemental oxygen for the preceding 2 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I have Group 1 PAH, which may be related to a genetic condition, drug use, or another disease.
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My diuretic dose and oxygen support have been stable for the last 2 months.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insulin Sensitivity
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,019 Previous Clinical Trials
1,365,041 Total Patients Enrolled
1 Trials studying Insulin Resistance
82 Patients Enrolled for Insulin Resistance
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,814 Previous Clinical Trials
47,290,841 Total Patients Enrolled
46 Trials studying Insulin Resistance
11,351 Patients Enrolled for Insulin Resistance
Gustavo Heresi, MDPrincipal InvestigatorThe Cleveland Clinic

Media Library

Nutrition and Exercise Clinical Trial Eligibility Overview. Trial Name: NCT03288025 — N/A
Insulin Resistance Research Study Groups: Nutrition and Exercise, Standard of Care
Insulin Resistance 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this research limited to adults aged 18 and over?

"This study seeks to enroll individuals aged 18 or older but not exceeding the age of 75."

Answered by AI

Do I qualify for participation in this investigation?

"This clinical trial is seeking around 34 participants who are aged 18 to 75 and suffer from pulmonary arterial hypertension."

Answered by AI

Are there any opportunities currently available to join this scientific research?

"The clinical trial's corresponding listing on the government-managed website clinicaltrials.gov reveals that this research initiative is not actively recruiting patients at present; it was first posted on September 27th 2017 and last edited back in May 6th 2022. Despite this, there are presently 907 other studies requiring participants."

Answered by AI
~5 spots leftby Mar 2025