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

March 13, 2009
June 29, 2009
April 2009
October 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00862043 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease
Sildenafil for Improving Outcomes After Valvular Correction

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pulmonary Hypertension
  • Valvular Heart Disease
  • Drug: Sildenafil Citrate
    40 mg t.i.d.
  • Drug: Placebo
    Placebo t.i.d.
  • Experimental: Sildenafil
    Intervention: Drug: Sildenafil Citrate
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
354
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Javier Bermejo, MD, PhD 34 91 5868815 jbermejot@gmail.com
Contact: Raquel Yotti, MD, PhD 34 91 5868279 ryotti@gmail.com
Spain
 
NCT00862043
FIBHGM-SIOVAC, EudraCT: 2007-007033-40, EC07-90772
Yes
Gerente, Fundacion para la Investigacion Biomedica Hospital Gregorio Maranon
Hospital General Universitario Gregorio Marañon
Instituto de Salud Carlos III
Principal Investigator: Javier Bermejo, MD, PhD Hospital General Universitario Gregorio Maranon
Hospital General Universitario Gregorio Marañon
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP