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Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease (SIOVAC)
This study has been completed.
Sponsor:
Hospital General Universitario Gregorio Marañon
Collaborators:
Instituto de Salud Carlos III
Fundación de Investigación en Red en Enfermedades Cardiovasculares
Information provided by (Responsible Party):
Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier:
NCT00862043
First received: March 13, 2009
Last updated: September 22, 2016
Last verified: September 2016
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Purpose
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 |
|---|---|---|
| Pulmonary Hypertension Valvular Heart Disease | Drug: Sildenafil Citrate Drug: Placebo | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Sildenafil for Improving Outcomes After Valvular Correction |
Resource links provided by NLM:
Further study details as provided by Hospital General Universitario Gregorio Marañon:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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 ]
| Enrollment: | 200 |
| Study Start Date: | April 2009 |
| Study Completion Date: | July 2016 |
| Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862043
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862043
Locations
| Spain | |
| Hospital Universitario Santiago de Compostela | |
| Santiago de Compostela, A Coruña, Spain | |
| Hospital Universitario Alava | |
| Vitoria, Alava, Spain | |
| Hospital German Trias y Pujol | |
| Badalona, Barcelona, Spain | |
| Hospital de la Santa Creu y San Pau | |
| Barcelona, Barcelon, Spain | |
| Hospital Fundación de Alcorcón | |
| Alcorcón, Madrid, Spain | |
| Hospital Puerta de Hierro | |
| Majadahonda, Madrid, Spain | |
| Hospital de Galdakao | |
| Galdakao, Vizcaya, Spain | |
| Hospital Reina Sofía | |
| Córdoba, Spain | |
| Hospital Virgen de las Nieves | |
| Granada, 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 Infanta Leonor | |
| Madrid, Spain | |
| Hospital Virgen de la Victoria | |
| Malaga, Spain | |
| Hospital Universitario de Salamanca | |
| Salamanca, Spain | |
| Hospital Universitario de Canarias | |
| Tenerife, Spain | |
| Hospital Clínico de Valladolid | |
| Valladolid, Spain | |
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Instituto de Salud Carlos III
Fundación de Investigación en Red en Enfermedades Cardiovasculares
Investigators
| Principal Investigator: | Javier Bermejo, MD, PhD | Hospital General Universitario Gregorio Maranon |
More Information
Additional Information:
| Responsible Party: | Hospital General Universitario Gregorio Marañon |
| ClinicalTrials.gov Identifier: | NCT00862043 History of Changes |
| Other Study ID Numbers: |
FIBHGM-SIOVAC 2007-007033-40 ( EudraCT Number ) EC07-90772 ( Other Identifier: Agencia Española del Medicamento y Productos Sanitarios ) |
| Study First Received: | March 13, 2009 |
| Last Updated: | September 22, 2016 |
Keywords provided by Hospital General Universitario Gregorio Marañon:
|
Secondary Pulmonary Hypertension Valvular Heart Disease Phosphodiesterase-Inhibitors Sildenafil Outcomes Research |
Additional relevant MeSH terms:
|
Hypertension Heart Diseases Hypertension, Pulmonary Heart Valve Diseases Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Citric Acid Sildenafil Citrate |
Anticoagulants Calcium Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Urological Agents |
ClinicalTrials.gov processed this record on July 26, 2017