Understanding heart function in patients with scleroderma and pulmonary hypertension
Understanding Right Ventricular Heart Failure in Scleroderma and Idiopathic Pulmonary Arterial Hypertension
This study is trying to understand how heart function changes in people with scleroderma and pulmonary hypertension to see if different treatments can help them better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04610788 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the mechanisms behind the development of pulmonary arterial hypertension (PAH) in patients with scleroderma and idiopathic PAH (IPAH). It will assess the right ventricle's response to standard PAH therapy through advanced Pressure-Volume Loop Assessment and right ventricular biopsy. Blood and tissue samples will be collected during routine procedures to analyze differences in heart function and identify potential therapeutic targets. The study will compare findings between patients with scleroderma-associated PAH and those with IPAH over a six-month treatment period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with clinically diagnosed scleroderma or known idiopathic pulmonary hypertension.
Not a fit: Patients with secondary pulmonary hypertension due to left heart failure or those who are hemodynamically unstable will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with scleroderma-associated pulmonary hypertension.
How similar studies have performed: Previous studies have indicated that understanding the differences in heart function between these patient groups could lead to significant advancements in treatment, suggesting a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 18 years or older with clinically diagnosed scleroderma or presumed/known idiopathic pulmonary hypertension. Exclusion Criteria: * Patients found to have secondary pulmonary hypertension (PH due to left heart failure) on clinical RHC. * 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. * In order to undergo the clinical right heart catheterization procedures, pregnancy testing (urine or serum) is standard of care. * Pregnancy
Where this trial is running
Baltimore, Maryland
- Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Paul Hassoun, MD — Johns Hopkins University
- Study coordinator: Paul Hassoun, MD
- Email: phassou1@jhmi.edu
- Phone: 410 614 6311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.