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Sponsors and Collaborators: |
Hospital General Universitario Gregorio Marañon Instituto de Salud Carlos III. Ministry of Science and Innovation |
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Information provided by: | Hospital General Universitario Gregorio Marañon |
ClinicalTrials.gov Identifier: | NCT00862043 |
The purpose of this study is to evaluate the clinical efficacy of the mid-term treatment with sildenafil in patients with persistent moderate or severe pulmonary hypertension (PH) after a heart valve intervention.
Condition | Intervention | Phase |
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Pulmonary Hypertension Valvular Heart Disease |
Drug: Sildenafil Citrate Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Sildenafil for Improving Outcomes After Valvular Correction |
Estimated Enrollment: | 354 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Sildenafil: Experimental |
Drug: Sildenafil Citrate
40 mg t.i.d.
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Placebo: Placebo Comparator |
Drug: Placebo
Placebo t.i.d.
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Phase IV, prospective, multicenter, randomized, double-blind, placebo-controlled, academically funded clinical trial, with 6 months follow-up. A total of 354 patients will be recruited. Inclusion criteria are: 1) successful surgical or percutaneous repair of a cardiac valve at least one year before screening and 2) persistent moderate or severe PH, and 3) absence of any residual significant valvular lesion. Patients will be randomized 1:1 to received sildenafil 40 mg t.i.d. or placebo. The primary endpoint is a clinical composite score combining: all-cause mortality, hospital admission for heart failure, World Health Organization (WHO) functional class, and the patient global assessment score. Additional clinical and mechanistic secondary end-points are defined.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Javier Bermejo, MD, PhD | 34 91 5868815 | jbermejot.hgugm@salud.madrid.org |
Contact: Raquel Yotti, MD, PhD | 34 91 5868279 | ryotti@gmail.com |
Spain | |
Hospital Vall d'Hebron | |
Barcelona, Spain | |
Hospital Juan Canalejo | |
La Coruna, Spain | |
Hospital de Leon | |
Leon, Spain | |
Hospital General Universitario Gregorio Maranon | |
Madrid, Spain, 28007 | |
Hospital 12 de Octubre | |
Madrid, Spain | |
Hospital Virgen de la Victoria | |
Malaga, Spain | |
Hospital Universitario de Salamanca | |
Salamanca, Spain | |
Hospital Clínico de Valladolid | |
Valladolid, Spain | |
Spain, Mallorca | |
Hospital Son Dureta | |
Palma de Mallorca, Mallorca, Spain |
Principal Investigator: | Javier Bermejo, MD, PhD | Hospital General Universitario Gregorio Maranon |
Responsible Party: | Fundacion para la Investigacion Biomedica Hospital Gregorio Maranon ( Gerente ) |
Study ID Numbers: | FIBHGM-SIOVAC, EudraCT: 2007-007033-40, EC07-90772 |
Study First Received: | March 13, 2009 |
Last Updated: | March 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00862043 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines; Spain: Ministry of Health; Spain: Ethics Committee |
Secondary Pulmonary Hypertension Valvular Heart Disease Phosphodiesterase-Inhibitors Sildenafil Outcomes Research |
Vasodilator Agents Heart Diseases Citric Acid Vascular Diseases Sildenafil Cardiovascular Agents Secondary Pulmonary Hypertension |
Heart Valve Diseases Phosphodiesterase Inhibitors Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Neoplasm Metastasis Hypertension |
Vasodilator Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Vascular Diseases Sildenafil Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions |
Heart Valve Diseases Phosphodiesterase Inhibitors Respiratory Tract Diseases Hypertension, Pulmonary Therapeutic Uses Lung Diseases Cardiovascular Diseases Hypertension |