Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension

September 10, 2012 updated by: Hospital Universitari Vall d'Hebron Research Institute

Study About Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension, at Last Moderate and Secondary at Valve Disease(Corrected With a Normally Functioning Prosthesis).

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Enric Domingo, Promotor
  • Phone Number: 00-34-93-2746455
  • Email: edrcg@hotmail.com

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Vall Hebron Hospital
        • Contact:
        • Principal Investigator:
          • Enric Domingo, Physician
        • Sub-Investigator:
          • Antonio Roman, Physician
        • Sub-Investigator:
          • Rio Aguilar, Physician
        • Sub-Investigator:
          • Carlos Bravo, Physician
        • Sub-Investigator:
          • Gisela Teixidor, Physician
        • Sub-Investigator:
          • Josep Guindo, Physician
        • Sub-Investigator:
          • Christian Arredondo, Physician

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sildenafil 20mg oral
Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous
2 arms to comparation: Sildenafil 20mg oral vs intravenous Sildenafil 10mg
Other Names:
  • REVATIO oral vs REVATIO intravenous
Other: Sildenafil 10mg intravenous
Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous
2 arms to comparation: Sildenafil 20mg oral vs intravenous Sildenafil 10mg
Other Names:
  • REVATIO oral vs REVATIO intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness
Time Frame: one day per patient
The main efficacy parameter is the effect on pulmonary vascular vasodilation quantified as decreased Pulmonary Vascular Resistance.
one day per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Enric Domingo, Promotor, Vall Hebron Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

March 2, 2010

First Submitted That Met QC Criteria

March 22, 2010

First Posted (Estimate)

March 23, 2010

Study Record Updates

Last Update Posted (Estimate)

September 11, 2012

Last Update Submitted That Met QC Criteria

September 10, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOM-SIL-2009
  • 2009-012005-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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