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Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03288025
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 The Cleveland Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Raed Dweik, MDGustavo Heresi, MD
Principal Investigator Affiliation The Cleveland ClinicThe Cleveland Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Pulmonary Arterial Hypertension, Insulin Resistance
Additional Details

Pulmonary arterial hypertension (PAH) leads to premature death as a consequence of increased pulmonary vascular resistance and right heart failure. PAH-targeted therapies developed over the past 20 years target excessive vasoconstriction. However, the pathobiology of PAH is more complicated, and includes dysregulated vascular cell proliferation, cellular metabolic abnormalities, and inflammation. Even with modern PAH therapies, current outcomes remain poor, with an estimated 3-year survival rate of only 55%. Thus, there is a clear need for more effective therapies, based on better understanding of the pathobiology of the disease. Insulin resistance has emerged as a potential new mechanism in PAH. Animal models of insulin resistance are associated with PAH, which reverses with the administration of insulin sensitizing drugs. Over the past decade there has been an epidemiologic shift in PAH, where the disease is increasingly observed in older, obese, and diabetic subjects. Low levels of high-density lipoprotein cholesterol in PAH, a feature of insulin resistance, have been observed and found to be a strong independent predictor of PAH mortality. Elevated glycosylated hemoglobin (HbA1c) also correlates with PAH diagnosis and severity. As measured by the OGTT, idiopathic PAH patients have not only insulin resistance, but also an inability to mount an appropriate insulin response to a glucose challenge. These data point to dysfunction in the pancreatic beta cells of PAH patients. It is known that an exercise and low glycemic index diet intervention improves insulin sensitivity in pre-diabetic subjects.

Arms & Interventions

Arms

Experimental: Nutrition and Exercise

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

No Intervention: Standard of Care

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

Interventions

Behavioral: - Nutrition and Exercise

5 times a week exercise training and biweekly diet counseling for 12 weeks.

Contact a Trial Team

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Cleveland Clinic Foundation, Cleveland, Ohio

Status

Address

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

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