Understanding hormonal and metabolic factors in pulmonary arterial hypertension

Hormonal, Metabolic, and Signaling Interaction in Pulmonary Arterial Hypertension

This study is trying to see how hormones like estrogen and testosterone, along with metabolic factors, affect pulmonary arterial hypertension (PAH) differently in men and women to help improve treatment options.

Quick facts

• Study type: Observational
• Enrollment: 1899 (estimated)
• Ages: N/A to 90 Years
• Sex: All
• Sponsor: Vanderbilt University Medical Center (other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT01884051 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the hormonal and metabolic pathways involved in pulmonary arterial hypertension (PAH), particularly focusing on gender differences in disease prevalence and progression. The research will investigate how estrogen and testosterone levels may influence the condition, with the goal of confirming earlier findings in a larger patient cohort. Additionally, the study will assess the metabolic syndrome's role in PAH and evaluate potential therapeutic approaches based on these insights. By understanding these interactions, the study seeks to pave the way for improved treatment strategies for PAH.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with idiopathic, heritable, or associated pulmonary arterial hypertension, as well as family members of affected persons aged 0-90.

Not a fit: Patients with other diagnoses or those unable to tolerate fasting or reach the clinic for testing may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to more effective and personalized treatments for patients suffering from pulmonary arterial hypertension.

How similar studies have performed: While there have been advances in understanding PAH, this specific approach focusing on hormonal and metabolic interactions is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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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Where this trial is running

Nashville, Tennessee

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)

Study contacts

• Principal investigator: James E Loyd, MD — Vanderbilt University Medical Center
• Study coordinator: Kelly L Fox

Conditions: Idiopathic Pulmonary Arterial Hypertension, Heritable Pulmonary Arterial Hypertension, Scleroderma Associated Pulmonary Arterial Hypertension, Appetite Suppressant Associate PAH, Pulmonary arterial hypertension