Status:
COMPLETED
Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease
Lead Sponsor:
Hospital General Universitario Gregorio Marañon
Collaborating Sponsors:
Instituto de Salud Carlos III
Fundación de Investigación en Red en Enfermedades Cardiovasculares
Conditions:
Pulmonary Hypertension
Valvular Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
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 crit...
Eligibility Criteria
Inclusion
- Age at the date of selection ≥ 18 years
- Mean pulmonary pressure ≥ 30 mmHg, measured by a Swan-Ganz catheter placed in the pulmonary artery
- Heart valve intervention: surgical or percutaneous replacement, repair or dilatation performed at least one year before inclusion
- Stable clinical condition for at least one month, without hospital admissions for heart failure, and on appropriate and stable doses of conventional cardiovascular medications
Exclusion
- Requiring or likely to require the following medications: organic nitrates, alpha-blocker therapy, potent cytochrome P450 3A4 inhibitors (erythromycin, ketoconazole, cimetidine, HIV protease inhibitors such ritonavir and saquinavir) Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months.
- Patients with resting hypotension, with systolic blood pressure \< 90 mmHg
- Patients with retinitis pigmentosa
- Anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease) or patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia)
- Severe renal impairment with creatinine clearance \< 30 ml/min
- Significant hepatic dysfunction
- Prosthesis or valvular dysfunction with hemodynamic repercussion.
- Pregnant or breast-feeding women
- Patients unlikely to cooperate in the study or with inability or unwillingness to give informed consent
- Life expectancy less than 2 years due to non-cardiac disease
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00862043
Start Date
April 1 2009
End Date
July 1 2016
Last Update
September 23 2016
Active Locations (18)
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1
Hospital Universitario Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
2
Hospital Universitario Alava
Vitoria-Gasteiz, Alava, Spain
3
Hospital German Trias y Pujol
Badalona, Barcelona, Spain
4
Hospital de la Santa Creu y San Pau
Barcelona, Barcelon, Spain