This trial is active, not recruiting.

Conditions pulmonary hypertension, valvular heart disease
Treatments sildenafil citrate, placebo
Phase phase 4
Sponsor Hospital General Universitario Gregorio Marañon
Collaborator Instituto de Salud Carlos III
Start date April 2009
End date July 2016
Trial size 200 participants
Trial identifier NCT00862043, 2007-007033-40, EC07-90772, FIBHGM-SIOVAC


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Sildenafil Citrate 40 mg t.i.d. oral
sildenafil citrate
40 mg t.i.d.
(Placebo Comparator)
Sildenafil-matched oral placebo 40 mg t.i.d
Placebo t.i.d.

Primary Outcomes

Combined Outcome End-Point: all-cause mortality or hospital admission for heart failure, worsening of World Health Organization (WHO) functional class, or of the patient global assessment score
time frame: Six months

Secondary Outcomes

Change from baseline to the sixth month in the in the six-minute walk test
time frame: 6 Months
Change on WHO functional capacity
time frame: 3 & 6 Months
All cause mortality
time frame: 6 Months
Cardiovascular mortality
time frame: 6 months
Number of hospital admissions caused by or related to heart failure in each patient
time frame: 6 months
Rate of progression/regression of tricuspid regurgitation by Doppler-echocardiography
time frame: 3 & 6 Months
Change on right ventricular (RV) dimensions and function assessed by Doppler echocardiography
time frame: 3 & 6 months
Change on RV volumes and function assessed by cardiac magnetic resonance
time frame: 6 Months
Change on the right catheterization hemodynamic parameters
time frame: 6 Months
Identify patients who are more likely to respond to therapy by pharmacogenetics analysis
time frame: 6 Months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

Official title Sildenafil for Improving Outcomes After Valvular Correction
Principal investigator Javier Bermejo, MD, PhD
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Hospital General Universitario Gregorio Marañon.