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
Sponsor:
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
  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:


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
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

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 Diseases
Heart Valve 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 July 23, 2014