Chronic Thromboembolic Pulmonary Hypertension Clinical Trial
Official title:
Use of Right Ventricular Conductance Catheter Guidance to Optimise Balloon Pulmonary Angioplasty as a Non Surgical Treatment of Chronic Thromboembolic Pulmonary Hypertension.
Balloon pulmonary angioplasty (BPA) treats patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). Intra-procedural markers of success to guide the intervention are lacking. The investigators propose to measure right ventricular (RV) pressure volume loops invasively and measure biomarkers at intervals during the course of a course of BPA. These data will be analysed to define load independent indices of RV functional improvement, cross correlated with biomarker data and be used to calibrate non-invasive assessment of ventriculo-arterial coupling by cardiac magnetic resonance imaging (CMR) to better detect responders of BPA and pulmonary endarterectomy (PEA).
Patients who have Chronic Thromboembolic Pulmonary Hypertension (CTEPH) can treated surgically or by undergoing minimally invasive balloon pulmonary angioplasty (BPA). However not all patients have resolution of their pulmonary hypertension following these procedures, and some patients who don't have pulmonary hypertension derive substantial benefit nonetheless from surgical clearance of their thromboembolic disease. Thus better understanding of the interaction between the blood vessels, the right heart workload, and symptoms and outcomes is required to predict treatment response. Ventriculo-arterial coupling is one such measure, quantifying the efficiency of transfer of energy from the right ventricle to the pulmonary arteries. Traditionally this has required invasive procedures involving intracavity conduction catheterisation of the right ventricle to simultaneously measure flow and pressure whilst altering preload. Not only is this invasive, but it is not routinely performed in clinical practice due to its complexity and requirement for specialised expertise and equipment. As CMR can simultaneously assess right ventricular and pulmonary function it may be able to assess function and ventriculo-arterial coupling non-invasively and allow for a more detailed and accessible mode of disease quantification and stratification. The investigators will measure how the right heart function changes during BPA in patients with inoperable CTEPH, measured using a conductance catheter placed within the pumping chamber on the right side of the heart (right ventricle). This will generate pressure volume loops to detect intra-procedural changes of ventriculo-arterial coupling that can be used to quantify treatment success. The investigators will also monitor the levels of a newly discovered vessel inflammatory marker in the blood - Angiopoietin 2 (Ang2), and N-terminal pro-brain natriuretic peptide (NT-Pro BNP) that may also be useful in identifying responders to treatment and help define the optimal treatment protocol for BPA. This participants will have CMR as standard of care. Data from CMR and invasive measurements of ventriculo-arterial coupling will determine the best CMR measures of coupling efficiency. These measures will then be applied within a large well-characterised cohort with long term follow-up to determine its association with symptoms, and outcomes following surgical intervention. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT06003244 -
High Altitude (HA) Residents With Pulmonary Vascular Diseases (PVD), 6 Minute Walk Distance (6MWD) Assessed at 2840m (HA) With and Without Supplemental Oxygen Therapy (SOT)
|
N/A | |
| Active, not recruiting |
NCT06092424 -
High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA)
|
N/A | |
| Active, not recruiting |
NCT06072417 -
HA Residents With PVD, SDB Assessed at HA (2840m) vs LA (Sea Level)
|
N/A | |
| Terminated |
NCT01953965 -
Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI.
|
Phase 2 | |
| Recruiting |
NCT02061787 -
the Application of Cardiopulmonary Exercise Testing in Assessment Outcome of Patients With Pulmonary Hypertension
|
||
| Not yet recruiting |
NCT03102294 -
Inspiratory Muscle Training in Chronic Thromboembolic Pulmonary Hypertension
|
N/A | |
| Recruiting |
NCT04071327 -
Pulmonary Hypertension Association Registry
|
||
| Completed |
NCT00313222 -
Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension
|
Phase 3 | |
| Recruiting |
NCT05311072 -
Change-a Multi-center Chronic Thromboembolic Pulmonary Hypertension （CTEPH） Database in China
|
||
| Recruiting |
NCT05340023 -
Proteomic Pattern Associated With the Diagnosis of Chronic Thromboembolic Pulmonary Hypertension
|
||
| Enrolling by invitation |
NCT05568927 -
Validation of SEARCH, a Novel Hierarchical Algorithm to Define Long-term Outcomes After Pulmonary Embolism
|
||
| Completed |
NCT03786367 -
Dyspnea in Chronic Thromboembolic Pulmonary Hypertension
|
||
| Recruiting |
NCT04081012 -
N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Chronic Thromboembolic Pulmonary Hypertension.
|
N/A | |
| Not yet recruiting |
NCT06384534 -
Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD)
|
N/A | |
| Withdrawn |
NCT05693779 -
Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension
|
N/A | |
| Not yet recruiting |
NCT02426203 -
3D Echocardiographic Assessment of RV Function in Patients Undergoing Pulmonary Endarterectomy
|
N/A | |
| Completed |
NCT02094001 -
Pilot Study to Evaluate Right Ventricular Function With Riociguat in CTEPH
|
Phase 2 | |
| Enrolling by invitation |
NCT03388476 -
Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension
|
||
| Recruiting |
NCT04206852 -
Safety and Efficacy of Balloon Pulmonary Angioplasty in China
|
||
| Completed |
NCT02111980 -
RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators
|
N/A |