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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01091012
Recruitment Status : Unknown
Verified September 2012 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Recruiting
First Posted : March 23, 2010
Last Update Posted : September 11, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: 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).
Study Start Date : September 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Sildenafil 20mg oral Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous
2 arms to comparation: Sildenafil 20mg oral vs intravenous Sildenafil 10mg
Other Name: REVATIO oral vs REVATIO intravenous
Sildenafil 10mg intravenous Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous
2 arms to comparation: Sildenafil 20mg oral vs intravenous Sildenafil 10mg
Other Name: REVATIO oral vs REVATIO intravenous


Outcome Measures

Primary Outcome Measures :
  1. Effectiveness [ Time Frame: one day per patient ]
    The main efficacy parameter is the effect on pulmonary vascular vasodilation quantified as decreased Pulmonary Vascular Resistance.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01091012


Contacts
Contact: Enric Domingo, Promotor 00-34-93-2746455 edrcg@hotmail.com

Locations
Spain
Vall Hebron Hospital Recruiting
Barcelona, Spain, 08035
Contact: Enric Domingo, Physician    00-34-93-2746455    edrcg@hotmail.com   
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         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
Principal Investigator: Enric Domingo, Promotor Vall Hebron Hospital
More Information

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01091012     History of Changes
Other Study ID Numbers: DOM-SIL-2009
2009-012005-19 ( EudraCT Number )
First Posted: March 23, 2010    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents