NCT01517854

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. Specifically the investigators will evaluate the potential efficacy and safety of sildenafil (Revatio) in a 16 week blinded, multicentre study.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2012

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
10 months until next milestone

Study Start

First participant enrolled

November 14, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2019

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

5 years

First QC Date

December 14, 2011

Last Update Submit

September 25, 2019

Conditions

Portopulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in PVR after 16 weeks of treatment

    16 weeks

Secondary Outcomes (11)

  • 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

    16 weeks

  • Hospitalizations

    16 weeks

  • Death

    16 weeks

  • Complications of liver disease

    16 weeks

  • MELD score

    16 weeks

  • +6 more secondary outcomes

Study Arms (2)

Revatio

ACTIVE COMPARATOR
Drug: Sildenafil

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SildenafilDRUG

20 mg Revatio (sildenafil citrate) three times a day

Revatio
PlaceboDRUG

Placebo identical to Revatio (sildenafil citrate) three times a day

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Lawson Health Research Institute (London Health Sciences Centre Research Inc.)

London, Ontario, N6C 2R5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, G1V 4G5, Canada

Location

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • John T Granton

    University Health Network, Toronto

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2011

First Posted

January 25, 2012

Study Start

November 14, 2012

Primary Completion

October 30, 2017

Study Completion

May 14, 2019

Last Updated

September 27, 2019

Record last verified: 2019-09

Locations

CA(3)