Status:
WITHDRAWN
TranspulmonarY Estrogen Gradient and Estrogen Receptors (TYEGER) in PAH
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
13+ years
Brief Summary
Pulmonary arterial hypertension (PAH) is a disease characterized by elevated pressures in the blood vessels of the lungs that is not caused by another disease processes. More specifically, it is defin...
Detailed Description
The strongest established risk factor for the progressively fatal disease pulmonary arterial hypertension (PAH) is female sex (\~3:1 female:male ratio). Investigators and others have found higher circ...
Eligibility Criteria
Inclusion
- Age 13 years or older
- Group 1: PH Patients, who have precapillary PH (PAH). Patients with and without a known PAH-associated gene mutation (e.g., a BMPR2 mutation) (i.e. those with HPAH and those with IPAH) will be identified based on previous genotyping. Investigators define pulmonary hypertension diagnostically by accepted clinical and cardiac catheterization criteria, including mean pulmonary arterial pressure of more than 25 mmHg. Precapillary PH (PAH) cases have pulmonary capillary or left atrial pressure of ≤15 mm Hg, and exclusion of other causes of pulmonary hypertension in accordance with accepted international standards of diagnostic criteria.
- Group 2: PVH Patients, who have pulmonary hypertension secondary to left heart disease. PVH cases have left ventricular (LV) filling pressure \>15 mmHg (measured by the pulmonary artery occlusion pressure or left ventricular end-diastolic pressure) and a diastolic pressure gradient \<7mmHg, indicating the absence of pulmonary vascular disease. Inclusion in this group will require a clinical diagnosis of systolic or diastolic heart failure and right heart catheterization on at least one occasion demonstrating elevated pulmonary wedge pressure and a normal (\< 16mmHg) trans-pulmonary gradient
- Group 3: Healthy Control Patients, who have no known history of cardiopulmonary disease recruited from the Vanderbilt Research Notification Distribution List and the population at large.
Exclusion
- Subjects with the following concurrent diagnoses
- Type 1 Diabetes Mellitus
- Polycystic ovarian disease
- Breast/uterine/endometrial cancer
- Subjects with the following concurrent exposures
- Use of hormone modifying therapy
- Use of hormone-containing pharmaceuticals including hormone replacement therapy.
Key Trial Info
Start Date :
January 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04280523
Start Date
January 5 2021
End Date
December 31 2023
Last Update
January 3 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203