Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease (SIOVAC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00862043 |
Recruitment Status :
Completed
First Posted : March 16, 2009
Last Update Posted : September 23, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Hypertension Valvular Heart Disease | Drug: Sildenafil Citrate Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Sildenafil for Improving Outcomes After Valvular Correction |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Sildenafil Citrate
Sildenafil Citrate 40 mg t.i.d. oral
|
Drug: Sildenafil Citrate
40 mg t.i.d. |
Placebo Comparator: Placebo
Sildenafil-matched oral placebo 40 mg t.i.d
|
Drug: Placebo
Placebo t.i.d. |
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862043

Principal Investigator: | Javier Bermejo, MD, PhD | Hospital General Universitario Gregorio Maranon |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hospital General Universitario Gregorio Marañon |
ClinicalTrials.gov Identifier: | NCT00862043 |
Other Study ID Numbers: |
FIBHGM-SIOVAC 2007-007033-40 ( EudraCT Number ) EC07-90772 ( Other Identifier: Agencia Española del Medicamento y Productos Sanitarios ) |
First Posted: | March 16, 2009 Key Record Dates |
Last Update Posted: | September 23, 2016 |
Last Verified: | September 2016 |
Secondary Pulmonary Hypertension Valvular Heart Disease Phosphodiesterase-Inhibitors Sildenafil Outcomes Research |
Hypertension, Pulmonary Hypertension Heart Diseases Heart Valve Diseases Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |
Sildenafil Citrate Molecular Mechanisms of Pharmacological Action Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Urological Agents |