Monitoring right ventricular function in pulmonary hypertension patients
Monitoring of the Influence of Approved PH-therapies RV-PA Coupling
This study looks at how starting new medications affects the heart's right side in people with pulmonary hypertension to help doctors make better treatment choices.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Giessen Academic / other |
| Locations | 1 site (Giessen, Hesse) |
| Trial ID | NCT05935865 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the acute changes in right ventricular function in patients with precapillary pulmonary hypertension following the initiation of pharmacological therapies. Participants will be monitored using a mobile, wireless system that continuously records right ventricular pressure signals. The study focuses on understanding the relationship between afterload and intrinsic contractility, which is crucial for managing pulmonary hypertension and preventing right heart failure. By assessing RV-PA coupling, the study seeks to provide insights that could inform treatment decisions for patients undergoing right heart catheterization.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with pulmonary hypertension who are treatment-naive or under ongoing vasoreactive therapy and require inpatient right heart catheterization.
Not a fit: Patients under 18 years old, those who are pregnant or breastfeeding, or individuals with contraindications for right heart catheterization will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of right ventricular function in pulmonary hypertension, leading to improved treatment strategies.
How similar studies have performed: While the approach of monitoring RV-PA coupling is established, this specific observational study may provide novel insights into the effects of pharmacological therapies on right ventricular function.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Initial diagnosis of PH (treatment-naive incident PH) of the Nice classifications 1 (PAH), 3 (PH related to lung diseases/hypoxia), and 4 (CTEPH), or known PH under ongoing vasoreactive therapy * No contraindications for right heart catheterization, conductance catheterization, or CorLog implantation * Written consent from the patient or their legal guardian Exclusion Criteria: * Absence of written consent * Invasive exclusion of PH * Age \< 18 years * Presence of contraindications for right heart catheterization, conductance catheterization, or CorLog implantation * Pregnancy or breastfeeding
Where this trial is running
Giessen, Hesse
- Department of Internal Medicine, Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center (UGMLC), German Center for Lung Research (DZL) — Giessen, Hesse, Germany (Recruiting)
Study contacts
- Study coordinator: Khodr Tello, MD
- Email: khodr.tello@innere.med.uni-giessen.de
- Phone: +49 (0)641 985 56022
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.