Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease (SIOVAC)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Hospital General Universitario Gregorio Marañon.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hospital General Universitario Gregorio Marañon
Collaborator:
Instituto de Salud Carlos III
Information provided by:
Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier:
NCT00862043
First received: March 13, 2009
Last updated: June 29, 2009
Last verified: June 2009
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Sildenafil for Improving Outcomes After Valvular Correction |
Resource links provided by NLM:
MedlinePlus related topics:
Heart Diseases
Heart Failure
Heart Valve Diseases
High Blood Pressure
Pulmonary Hypertension
U.S. FDA Resources
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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline to the sixth month in the in the six-minute walk test [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- Change on WHO functional capacity [ Time Frame: 3 & 6 Months ] [ Designated as safety issue: No ]
- All cause mortality [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
- Cardiovascular mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Number of hospital admissions caused by or related to heart failure in each patient [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Rate of progression/regression of tricuspid regurgitation by Doppler-echocardiography [ Time Frame: 3 & 6 Months ] [ Designated as safety issue: No ]
- Change on RV dimensions and function assessed by Doppler echocardiography [ Time Frame: 3 & 6 months ] [ Designated as safety issue: No ]
- Change on RV volumes and function assessed by cardiac magnetic resonance [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- Change on the right catheterization hemodynamic parameters [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- Identify patients who are more likely to respond to therapy by pharmacogenetics analysis [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 354 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sildenafil |
Drug: Sildenafil Citrate
40 mg t.i.d.
|
| Placebo Comparator: Placebo |
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 |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862043
Contacts
| Contact: Javier Bermejo, MD, PhD | 34 91 5868815 | jbermejot@gmail.com |
| Contact: Raquel Yotti, MD, PhD | 34 91 5868279 | ryotti@gmail.com |
Locations
| Spain | |
| Hospital Son Dureta | Recruiting |
| Palma de Mallorca, Mallorca, Spain | |
| Principal Investigator: Armando Bethencourt, MD, PhD | |
| Sub-Investigator: Alfredo Gómez-Jaume, MD | |
| Hospital Vall d'Hebron | Not yet recruiting |
| Barcelona, Spain | |
| Principal Investigator: Pilar Tornos, MD, PhD | |
| Hospital Juan Canalejo | Recruiting |
| La Coruna, Spain | |
| Sub-Investigator: Maria G Crespo, MD, PhD | |
| Principal Investigator: Jose Cuenca, MD, PhD | |
| Hospital de Leon | Recruiting |
| Leon, Spain | |
| Principal Investigator: Mario Castano, MD | |
| Sub-Investigator: Armando Perez de Prado, MD | |
| Hospital General Universitario Gregorio Maranon | Recruiting |
| Madrid, Spain, 28007 | |
| Principal Investigator: Javier Bermejo, MD, PhD | |
| Sub-Investigator: Raquel Yotti, MD, PhD | |
| Hospital 12 de Octubre | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Carlos Saenz de la Calzada, MD, PhD | |
| Sub-Investigator: Pilar Escribano, MD, PhD | |
| Hospital Virgen de la Victoria | Recruiting |
| Malaga, Spain | |
| Principal Investigator: Eduardo de Teresa, MD, PhD | |
| Sub-Investigator: Manuel Jiménez-Navarro, MD, PhD | |
| Hospital Universitario de Salamanca | Recruiting |
| Salamanca, Spain | |
| Principal Investigator: Jose Maria Gonzalez-Santos, MD, PhD | |
| Sub-Investigator: Candido Martin-Luengo, MD, PhD | |
| Hospital Clínico de Valladolid | Recruiting |
| Valladolid, Spain | |
| Principal Investigator: Jose A San-Roman, MD, PhD | |
| Sub-Investigator: Luis de la Fuente, MD, PhD | |
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Instituto de Salud Carlos III
Investigators
| Principal Investigator: | Javier Bermejo, MD, PhD | Hospital General Universitario Gregorio Maranon |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gerente, Fundacion para la Investigacion Biomedica Hospital Gregorio Maranon |
| ClinicalTrials.gov Identifier: | NCT00862043 History of Changes |
| Other Study ID Numbers: | FIBHGM-SIOVAC, EudraCT: 2007-007033-40, EC07-90772 |
| Study First Received: | March 13, 2009 |
| Last Updated: | June 29, 2009 |
| Health Authority: | Spain: Spanish Agency of Medicines Spain: Ministry of Health Spain: Ethics Committee |
Keywords provided by Hospital General Universitario Gregorio Marañon:
|
Secondary Pulmonary Hypertension Valvular Heart Disease Phosphodiesterase-Inhibitors Sildenafil Outcomes Research |
Additional relevant MeSH terms:
|
Heart Valve Diseases Heart Diseases Hypertension Hypertension, Pulmonary Cardiovascular Diseases Vascular Diseases Lung Diseases Respiratory Tract Diseases Phosphodiesterase Inhibitors |
Sildenafil Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Therapeutic Uses Phosphodiesterase 5 Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013