Revatio Portal-Pulmonary Arterial Hypertension Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01517854
• Date of registration: 14/12/2011
• Prospective Registration: Yes
• Primary sponsor: University Health Network, Toronto
• Public title: Revatio Portal-Pulmonary Arterial Hypertension Trial RePo1
• Scientific title: Revatio Portal-Pulmonary Arterial Hypertension Trial (RePo1 Trial): A Randomized, Double-blinded, Placebo-controlled, Multi-center Study to Evaluate the Effects of Sildenafil Citrate (Revatio) 20 mg TID on Patients With Portal Pulmonary Arterial Hypertension (PPAH)
• Date of first enrolment: November 14, 2012
• Target sample size: 12
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01517854
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: John T Granton
• Affiliation: University Health Network, Toronto

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Portopulmonary Hypertension

Intervention(s)

Drug: Sildenafil

Drug: Placebo

Primary Outcome(s)

Change from baseline in PVR after 16 weeks of treatment [Time Frame: 16 weeks]

Secondary Outcome(s)

Change from baseline in CAMPHOR and SF-36 measures of quality of life [Time Frame: 16 weeks]

Change in baseline WHO functional class [Time Frame: 16 weeks]

Complications of liver disease [Time Frame: 16 weeks]

Change in Brain Natruretic Peptide (BNP) from baseline [Time Frame: 16 weeks]

Death [Time Frame: 16 weeks]

For patients with a PVR>450 dynes/sec/cm5 at baseline, number of patients who have PVR below 350 dynes/sec/cm5 after 16 weeks of study drug will be determined [Time Frame: 16 weeks]

MELD score [Time Frame: 16 weeks]

Renal dysfunction [Time Frame: 16 weeks]

Hospitalizations [Time Frame: 16 weeks]

Change in 6MWD from baseline [Time Frame: 16 weeks]

Desaturation [Time Frame: 16 weeks]

Secondary ID(s)

RePo1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors