NCT01091012

Brief Summary

The main objective is to validate the safety and efficacy of intravenous and oral sildenafil in the acute vasodilator test in patients with persistence of, at least, moderate pulmonary hypertension after valvular surgery successfully, with a correct left ventricular function and no valvular disease hemodynamically significant.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2010

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 23, 2010

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

1.3 years

First QC Date

March 2, 2010

Last Update Submit

September 10, 2012

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Effectiveness

    The main efficacy parameter is the effect on pulmonary vascular vasodilation quantified as decreased Pulmonary Vascular Resistance.

    one day per patient

Study Arms (2)

Sildenafil 20mg oral

OTHER
Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous

Sildenafil 10mg intravenous

OTHER
Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous

Interventions

Sildenafil 20mg oral vs Sildenafil 10mg intravenousDRUG

2 arms to comparation: Sildenafil 20mg oral vs intravenous Sildenafil 10mg

Also known as: REVATIO oral vs REVATIO intravenous
Sildenafil 10mg intravenousSildenafil 20mg oral

Eligibility Criteria

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

You may qualify if:

  • Patients clinically stable, at least 1 year after the completion of successful valve surgery, with persistent pulmonary artery systolic pressure\> 50 mmHg,
  • normal left ventricular function and no significant valvular disease in 2 separate Doppler ultrasound studies at least 1 month.

You may not qualify if:

  • Patients with other cardiac and noncardiac diseases will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vall Hebron Hospital

Barcelona, Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Enric Domingo, Promotor

    Vall Hebron Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Enric Domingo, Promotor

CONTACT

00-34-93-2746455edrcg@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2010

First Posted

March 23, 2010

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations

ES(1)