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Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease (SIOVAC)

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ClinicalTrials.gov Identifier: NCT00862043
Recruitment Status : Completed
First Posted : March 16, 2009
Last Update Posted : September 23, 2016
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Fundación de Investigación en Red en Enfermedades Cardiovasculares
Information provided by (Responsible Party):
Hospital General Universitario Gregorio Marañon

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Pulmonary Hypertension Valvular Heart Disease Drug: Sildenafil Citrate Drug: Placebo Phase 4

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.
Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Change from baseline to the sixth month in the in the six-minute walk test [ Time Frame: 6 Months ]
  2. Change on WHO functional capacity [ Time Frame: 3 & 6 Months ]
  3. All cause mortality [ Time Frame: 6 Months ]
  4. Cardiovascular mortality [ Time Frame: 6 months ]
  5. Number of hospital admissions caused by or related to heart failure in each patient [ Time Frame: 6 months ]
  6. Rate of progression/regression of tricuspid regurgitation by Doppler-echocardiography [ Time Frame: 3 & 6 Months ]
  7. Change on right ventricular (RV) dimensions and function assessed by Doppler echocardiography [ Time Frame: 3 & 6 months ]
  8. Change on RV volumes and function assessed by cardiac magnetic resonance [ Time Frame: 6 Months ]
  9. Change on the right catheterization hemodynamic parameters [ Time Frame: 6 Months ]
  10. Identify patients who are more likely to respond to therapy by pharmacogenetics analysis [ Time Frame: 6 Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Instituto de Salud Carlos III
Fundación de Investigación en Red en Enfermedades Cardiovasculares
Investigators
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Principal Investigator: Javier Bermejo, MD, PhD Hospital General Universitario Gregorio Maranon
More Information
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Additional Information:
Funding Agent  This link exits the ClinicalTrials.gov site Funding Agent  This link exits the ClinicalTrials.gov site Cardiovascular Research Spanish National Network  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Hospital General Universitario Gregorio Marañon:
Secondary Pulmonary Hypertension
Valvular Heart Disease
Phosphodiesterase-Inhibitors
Sildenafil
Outcomes Research
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Heart Diseases
Heart Valve Diseases
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Citric Acid
Sodium 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