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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Johns Hopkins
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.