Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01091012
Other study ID # DOM-SIL-2009
Secondary ID 2009-012005-19
Status Recruiting
Phase Phase 3
First received March 2, 2010
Last updated September 10, 2012
Start date September 2011
Est. completion date February 2013

Study information

Verified date September 2012
Source Hospital Universitari Vall d'Hebron Research Institute
Contact Enric Domingo, Promotor
Phone 00-34-93-2746455
Email edrcg@hotmail.com
Is FDA regulated No
Health authority Spain: Ethics CommitteeSpain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date February 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Intervention

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

Locations

Country Name City State
Spain Vall Hebron Hospital Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness The main efficacy parameter is the effect on pulmonary vascular vasodilation quantified as decreased Pulmonary Vascular Resistance. one day per patient No
See also
  Status Clinical Trial Phase
Withdrawn NCT01950585 - Hydroxyurea in Pulmonary Arterial Hypertension Early Phase 1
Completed NCT00527163 - Role of Nitric Oxide in Malaria
Completed NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing Phase 1
Recruiting NCT04554160 - Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Completed NCT01894035 - Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation
Not yet recruiting NCT04083729 - Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy N/A
Completed NCT02821156 - Study on the Use of Inhaled NO (iNO) N/A
Terminated NCT02243111 - Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound N/A
Terminated NCT02246348 - Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc) N/A
Completed NCT02216279 - Phase-II Study of the Use of PulmoBind for Molecular Imaging of Pulmonary Hypertension Phase 2
Recruiting NCT01913847 - Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension Phase 3
Completed NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability N/A
Completed NCT06240871 - Contrast Enhanced PA Pressure Measurements
Completed NCT02377934 - Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study
Completed NCT01463514 - Noninvasive Determination of Cerebral Tissue Oxygenation in Pulmonary Hypertension N/A
Completed NCT02275793 - The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure
Completed NCT00739375 - The Effect of Blood Flow in the Maturing Arteriovenous Access for Hemodialysis on the Development of Pulmonary Hypertension. Phase 1
Completed NCT01484899 - Smoking: a Risk Factor for Pulmonary Arterial Hypertension? N/A
Recruiting NCT02061787 - the Application of Cardiopulmonary Exercise Testing in Assessment Outcome of Patients With Pulmonary Hypertension