Recruiting

Metabolic Pathways

Sponsor:

Vanderbilt University Medical Center

Code:

NCT01884051

Conditions

Idiopathic Pulmonary Arterial Hypertension

Heritable Pulmonary Arterial Hypertension

Scleroderma Associated Pulmonary Arterial Hypertension

Appetite Suppressant Associate PAH

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Our hypothesis is that optimal treatment of the dysfunctional metabolic pathways which underlie PAH will improve pulmonary vascular function and consequences of the disease.

Conditions

Idiopathic Pulmonary Arterial Hypertension

Heritable Pulmonary Arterial Hypertension

Scleroderma Associated Pulmonary Arterial Hypertension

Appetite Suppressant Associate PAH

Study ID

NCT01884051

Start date

Sep, 2012

Status verified date

Sep, 2025

Completion date

Jul, 2032

Anticipated

Primary completion date

Jul, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Project 1

Inclusion:

1. Diagnosis of IPAH (idiopathic pulmonary arterial hypertension), HPAH (heritable pulmonary arterial hypertension), or APAH (associated pulmonary arterial hypertension), family members of affected persons
2. Age 0-90, age 12-90 for skin biopsy

Exclusion:

1. Other diagnosis
2. Age greater than 90, age less than 12 or greater than 90 for skin biopsy

Project 2

Inclusion:

1. Diagnosis of IPAH, HPAH, or APAH, family members of affected persons
2. 0-90
3. Subjects with reasonably easy access to clinic for blood collection and other testing
4. Subject able to tolerate fasting state prior to sample collection and EndoPAT (endothelial function assessment) testing

Exclusion:

1. Other diagnosis
2. 0-90
3. Subjects with difficulty reaching clinic for blood collection and other testing
4. Subjects unable to tolerate fasting state

Project 3

Inclusion:

1. Diagnosis of IPAH, HPAH, or APAH, family members of affected persons
2. 7-90

Exclusion:

1. Other diagnosis
2. Age less than 7 or greater than 90

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Exclusion Criteria:

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Study Design

Enrollment

1899 participants

Anticipated

Interventions and Outcome Measures

Arms

PAH patients

Patients diagnosed with WHO Group 1 PAH

Healthy subjects

Subjects who have been evaluated for heart and lung disease and found to be healthy

Primary outcome measure

  • Ratio of sex hormone metabolites [ Time Frame: 5 years ]
  • Evaluation of insulin resistance in pulmonary arterial hypertension patients/Clinical trial of Metformin in Pulmonary Arterial Hypertension [ Time Frame: 5 years ]
  • Mechanism, safety, and efficacy of ACE-2 (Angiotensin Converting Enzyme 2) in the treatment of PAH. [ Time Frame: 5 years ]
  • Clinical Trial of Metformin in Pulmonary Arterial Hypertension [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Kelly L Fox

800-288-0378Kelly.Burke@vumc.org

Shannon Cordell, BSN

615-343-8277shannon.eason@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Sep 16, 2025

Last verified

Sep, 2025

Keywords

  • Pulmonary arterial hypertension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-09-16.