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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Hospital Universitari Vall d'Hebron Research Institute
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01091012
First received: March 2, 2010
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Pulmonary Hypertension
Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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).

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Effectiveness [ Time Frame: one day per patient ] [ Designated as safety issue: No ]
    The main efficacy parameter is the effect on pulmonary vascular vasodilation quantified as decreased Pulmonary Vascular Resistance.


Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 2, 2010
Last Updated: September 10, 2012
Health Authority: Spain: Ethics Committee
Spain: Spanish Agency of Medicines

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

ClinicalTrials.gov processed this record on August 21, 2014