6-MP Trial
Recruiting
- Conditions
- Pulmonary arterial hypertension
- Registration Number
- NL-OMON29513
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Age > 18 years
-Diagnosis of idiopathic, hereditary or drug-induced PAH
Exclusion Criteria
-PAH of any cause other than permitted in the entry criteria
-Contraindication for right heart catheterization or CMR imaging
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of the study is the change in PVR, measured by right heart catheterization.
- Secondary Outcome Measures
Name Time Method The key secondary endpoints of this study are:<br /><br>Hemodynamically:<br /><br>•A change in mean pulmonary artery pressure (mPAP)<br /><br>•A change in cardiac output (CO)<br /><br>•A change in right atrial pressure (RAP)<br /><br>Clinical:<br /><br>•A change in FC<br /><br>•Hospitalization for congestive heart failure (CHF)<br /><br>•A change in VO2 max<br /><br>•A change in 6 minute walking distance<br /><br>Laboratory:<br /><br>•NT-proBNP (pmol/L)<br /><br>•Whole blood count<br /><br>•Kidney function<br /><br>•Liver tests<br /><br>•Platelet transcriptome<br /><br>Cardiovascular magnetic resonance imaging (CMR):<br /><br>•A change in right ventricular ejection fraction (RVEF) (%)<br /><br>•A change in right ventricular end diastolic volume (RVEDV) (ml)<br /><br>•A change in right ventricular end systolic volume (RVESV) (ml)<br /><br>Questionnaires:<br /><br>•A change in Living with Pulmonary Hypertension questionnaire (LPH)<br /><br>•A change in BORG dyspnea score<br />