Observational Study of Hormonal and Metabolic Factors in PAH
This observational study aims to understand why women are more affected by pulmonary arterial hypertension (PAH) than men. Researchers are looking at how sex hormones, like estrogen and testosterone, and metabolic pathways might influence the disease. They will measure the ratio of sex hormone metabolites and evaluate insulin resistance in people with PAH over five years. This study is open to individuals aged 0 to 90 with idiopathic (unknown cause), heritable (runs in families), or associated forms of PAH, as well as family members of affected individuals. The goal is to identify potential targets for future treatments, such as Metformin or ACE-2 (Angiotensin Converting Enzyme 2), that could improve pulmonary vascular function.
- Study design
- This is an observational study planning to enroll up to 1899 participants. It is not testing a specific intervention but rather observing natural processes.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for five years to measure sex hormone metabolites and evaluate insulin resistance.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Hormonal, Metabolic, and Signaling Interactions in PAH
At a glance
Conditions
NCT01884051
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Vanderbilt University Medical Center
Nashville, Tennesseeno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- James E Loyd, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Ratio of sex hormone metabolites5 years
The primary outcome measure is the ratio of 2-hydroxyestrogens to 16-hydroxyestrogens among patients compared to both controls and at risk but well subjects.
- Evaluation of insulin resistance in pulmonary arterial hypertension patients/Clinical trial of Metformin in Pulmonary Arterial Hypertension5 years
We will assess various measures of insulin resistance among patients, compared to healthy control subjects as well as at risk but well subjects. The primary measure will be assessed using the glucose clamp technique to quantify insulin secretion and resistance.
- Mechanism, safety, and efficacy of ACE-2 (Angiotensin Converting Enzyme 2) in the treatment of PAH.5 years
We will assess the safety and efficacy of ACE-2 for the treatment of established PAH. The primary objective of the study is to determine safety of rhACE2 when administered as a single dose or multiple doses intravenously to subjects with PAH receiving background PAH-specific therapy.
- Clinical Trial of Metformin in Pulmonary Arterial Hypertension3 years
Specific Aim 1. To test the hypothesis that metformin will ameliorate oxidant stress in pulmonary arterial hypertension Primary safety endpoint: absence of lactic acidosis, withdrawal from the study if attributed to metformin Primary efficacy endpoint: change in urinary and plasma oxidant stress measures (F2 isoprostanes and metabolites, isofurans, and nitrotyrosine) Specific Aim 2. To test the hypothesis that metformin will decrease myocardial lipid content, increase oxidative metabolism and decrease glucose uptake. Primary Endpoints: change in myocardial percent triglycerides (%TGs), kmono/RPP of C11 acetate, and uptake of FDG before and after metformin.