NCT04610788Completed
Cardiac Assessment by PV Loop in IPAH and Scleroderma PAH
Understanding Right Ventricular Heart Failure in Scleroderma and Idiopathic Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov · Last updated 9 Jan 2026
Brief summary (registry, in English)
This observational study is being done to understand why people with scleroderma can develop pulmonary arterial hypertension (high blood pressure in the lungs, abbreviated PAH) and a weak heart muscle (heart failure). The study will also help the investigators understand why people with PAH from an unknown cause (called idiopathic PAH, or IPAH) can also develop a weakened heart muscle. The response of the right side of the heart or right ventricle (RV) to standard PAH therapy in scleroderma-associated PAH and in IPAH will be assessed. Blood and tissue samples will be collected from research participants during participants' normal standard of care procedures. People with scleroderma-associated PAH or idiopathic cause (IPAH) who need a right heart catheterization may join this study.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 43 (actual)
- First submitted
- 26 Oct 2020
- Start date
- 15 Apr 2019
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Johns Hopkins University
- Diseases
- Heart failure, Systemic sclerosis (scleroderma), Pulmonary arterial hypertension, High blood pressure
- NCT number
- NCT04610788
What you commit to
- Study type: Observational
- Participants enrolled: 43
- From 15 Apr 2019 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients found to have secondary pulmonary hypertension (PH due to left heart failure) on clinical RHC.
Lab values
- In order to undergo the clinical right heart catheterization procedures, pregnancy testing (urine or serum) is standard of care.
Other
- Hemodynamically unstable patients (systolic blood pressure \< 90mmHg, vasopressor requirement).
- Patients whom are unable to give consent for themselves.
- Patients with RV clot or septal aneurysm will be excluded.
- Pregnancy
Who the study is looking for
- Patients 18 years or older with clinically diagnosed scleroderma or presumed/known idiopathic pulmonary hypertension.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.