Elevated lung blood pressure Pulmonary Hypertension
Conditions
Interventions
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Suspected or proven PH, for which right heart catherization is scheduled Ability to provide written informed consent Age between 18 and 90 years old
Exclusion criteria
Exclusion criteria: Pregnancy Renal failure (defined as eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study parameters: - Microvascular resistance obtained using the Combowire - Pulmonary vascular resistance obtained using Swan-Ganz measurements Endpoint: For the prediction of the composite endpoint of all-cause mortality, atrial septostomy, lung transplantation, worsening of WHO functional class, 15% reduction of 6 minute walk test at 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pulmonary vascular resistance and microvascular resistance under vasodilated conditions induced by nitric oxide ventilation - Cardiac output measurements using Swan-Ganz obtained under both resting and vasodilated conditions CTEPH substudy - Same Swan-Ganz measurements as in the main study. - Combowire measurements will be performed proximal and distal to the occlusion site (if deemed technically feasible by the operator), and repeated after revascularization. - Combowire measurement in an unobstructed reference artery. - Optical Coherence Tomography measurements to determine vessel diameter if the patient is revascularized using percutaneous balloon angioplasty. Acquiring the vessel diameter in combination with flow velocity and distal pressure, allows calculation of true microvascular resistance (MVRtrue) in the subtended vascular bed. 1) Paired change in resistance calculated over the obstructed segment before and after angioplasty 2) Paired change in MVRtrue before and after angioplasty 3) Development of the resistance over the obstructed segment and the MVR true at follow-up in both previously obstructed as well as reference vessels in relation to the development of PAP (i.e. needed reductions in resistance over the obstructed segment and MVRtrue for a reduction in 1 mmHg of PAP at a follow-up visit), | — |
Countries
The Netherlands
Outcome results
None listed