Assessing heart function during balloon treatment for pulmonary hypertension
Use of Right Ventricular Conductance Catheter Guidance to Optimise Balloon Pulmonary Angioplasty as a Non Surgical Treatment of Chronic Thromboembolic Pulmonary Hypertension.
Papworth Hospital NHS Foundation Trust · NCT04444973
This study is testing how balloon treatment for a specific type of lung high blood pressure affects heart function in patients who can’t have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Papworth Hospital NHS Foundation Trust (other gov) |
| Locations | 1 site (Cambridge) |
| Trial ID | NCT04444973 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) undergoing balloon pulmonary angioplasty (BPA). The researchers aim to measure right ventricular pressure volume loops and biomarkers during the procedure to better understand the relationship between right heart function and treatment outcomes. By analyzing these data, the study seeks to develop non-invasive methods for assessing the effectiveness of BPA and pulmonary endarterectomy. This could lead to improved patient selection and treatment strategies for those suffering from CTEPH.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with inoperable CTEPH who are eligible for BPA treatment.
Not a fit: Patients with severe co-morbidities, significant left to right shunts, or other specific exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict which patients will benefit from balloon pulmonary angioplasty, leading to better treatment outcomes.
How similar studies have performed: While the approach of using non-invasive assessments is promising, this specific methodology has not been widely tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>18 years old * Able to provide informed consent * Inoperable CTEPH eligible for BPA treatment Exclusion Criteria: * Severe co-morbidity (expected life \<6months) * Women of child bearing age * Significant known left to right shunt * Permanent pacemaker * Atrial fibrillation * Severe lung parenchyma disease ( eg emphysema, Interstitial Lung Disease (ILD)). * Retained metallic foreign body
Where this trial is running
Cambridge
- Royal Papworth Hospital — Cambridge, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Stephen P Hoole, MD — Royal Papworth Hospital
- Study coordinator: Sarah Fielding, PhD
- Email: sarah.fielding2@nhs.net
- Phone: +441223639960
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.
Conditions: Chronic Thromboembolic Pulmonary Hypertension, Balloon pulmonary angioplasty