Status:
TERMINATED
Revatio Portal-Pulmonary Arterial Hypertension Trial
Lead Sponsor:
University Health Network, Toronto
Conditions:
Portopulmonary Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The investigators propose the first prospective, double blind, randomized controlled trial of treatment for pulmonary arterial hypertension (PAH) related to underlying portal hypertension. Specificall...
Detailed Description
PAH is a recognized complication of portal hypertension - termed portal-pulmonary hypertension (PPHTN). In the World Health Organization (WHO) classification PPHTN is categorized as a WHO group 1 cond...
Eligibility Criteria
Inclusion
- Male and female patients with PPHTN.
- A 6MWD test between 150 m and 450 m.
- A pulmonary vascular resistance (PVR) \>250 dyn\*sec\*cm-5, a mean pulmonary artery pressure (PAPmean) ≥25 mmHg due to portal hypertension, and PCWP ≤ 15 mmHg. Right-heart catheterization results for the definite diagnosis of PH must follow the 2 - 6 week pre-treatment phase and not be older than 6 weeks at study start (will be considered as baseline values).
- Portal hypertension defined either clinically or hemodynamically by the presence of cirrhosis (by ultrasound or biopsy) or portal vein thrombosis / obstruction (proven by portal vein Doppler) and any one of the following within one year of entry into the study: 1) Ascites (on ultrasound of the abdomen); 2) Splenomegaly (on ultrasound of the abdomen); 3) Esophageal or Gastric Varices (proven endoscopically); 4) Hepatic-venous pressure gradient (HVPG) \> 12 mmHg.
- Treatment naive patients (with respect to PAH specific medication) and patients. Prior use of sildenafil for erectile dysfunction will be permitted.
- 18 to 75 years of age at Visit 1.
- Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period.
- Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures.
Exclusion
- Participation in another clinical trial during the preceding 3 months.
- Pregnant women or breast feeding women.
- Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator or the sponsor.
- Patients with a history of severe allergies or multiple drug allergies.
- Patients with hypersensitivity to the investigational drug or inactive constituents.
Key Trial Info
Start Date :
November 14 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01517854
Start Date
November 14 2012
End Date
May 14 2019
Last Update
September 27 2019
Active Locations (3)
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1
Lawson Health Research Institute (London Health Sciences Centre Research Inc.)
London, Ontario, Canada, N6C 2R5
2
University Health Network
Toronto, Ontario, Canada, M5G 2N2
3
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Canada, G1V 4G5