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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 October 2016 |
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Main ID: |
NCT00862043 |
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Date of registration:
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13/03/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease
SIOVAC |
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Scientific title:
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Sildenafil for Improving Outcomes After Valvular Correction |
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Date of first enrolment:
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April 2009 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00862043 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Spain
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Contacts
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Name:
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Javier Bermejo, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital General Universitario Gregorio Maranon |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Valvular Heart Disease
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Pulmonary Hypertension
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Intervention(s)
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Drug: Sildenafil Citrate
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Drug: Placebo
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Cardiovascular mortality
[Time Frame: 6 months]
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Change on right ventricular (RV) dimensions and function assessed by Doppler echocardiography
[Time Frame: 3 & 6 months]
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Rate of progression/regression of tricuspid regurgitation by Doppler-echocardiography
[Time Frame: 3 & 6 Months]
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Number of hospital admissions caused by or related to heart failure in each patient
[Time Frame: 6 months]
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Change from baseline to the sixth month in the in the six-minute walk test
[Time Frame: 6 Months]
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Change on the right catheterization hemodynamic parameters
[Time Frame: 6 Months]
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All cause mortality
[Time Frame: 6 Months]
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Identify patients who are more likely to respond to therapy by pharmacogenetics analysis
[Time Frame: 6 Months]
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Change on WHO functional capacity
[Time Frame: 3 & 6 Months]
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Change on RV volumes and function assessed by cardiac magnetic resonance
[Time Frame: 6 Months]
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Secondary ID(s)
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FIBHGM-SIOVAC
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2007-007033-40
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EC07-90772
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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