Status:
UNKNOWN
Repeatability and Sensitivity to Change of Non-invasive Endpoints in PAH
Lead Sponsor:
University of Sheffield
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
Phase:
NA
Brief Summary
Pulmonary arterial hypertension (PAH) is progressive life limiting disease with a median survival of less than 3 years without treatment. Current drug trials in PAH commonly use simple tests for examp...
Detailed Description
Background: Pulmonary arterial hypertension (PAH) is a rare but severe and progressive disorder, with a prevalence of approximately 50 in 1,000,000 of the population. The condition is incurable with ...
Eligibility Criteria
Inclusion
- Patients with PAH
- PAH subject is diagnosed with Group 1 pulmonary arterial hypertension, including IPAH, hereditable and CTD, and PAH associated with portal hypertension
- Mean pulmonary arterial pressure ≥ 25 mmHg
- Pulmonary arterial wedge pressure ≤ 15 mmHg
Exclusion
- Inability to perform the study protocol
- Significant comorbidity where in the opinion of the clinician this is a significant contributor to the patients PAH
- Pregnancy
- Allergy to contrast medium
- Contraindication to MRI (as per standard screening questionnaire)
- Significant lung disease.
- Known Hep B,C, HIV
- Healthy volunteers
- Inclusion criteria:
- Male or female aged between 18 years and 60 years
- Currently healthy as determined by a responsible physician
- No significant history of lung or cardiac disease and normal BNP.
- Capable of giving written informed consent.
- Subject is \>50kg with a body mass index within the range 18.0 to 32kg/m2.
Key Trial Info
Start Date :
September 15 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2019
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03841344
Start Date
September 15 2015
End Date
May 20 2019
Last Update
February 18 2019
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