Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease

Brief Title

Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease

Official Title

Sildenafil for Improving Outcomes After Valvular Correction

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.
    

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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Change from baseline to the sixth month in the in the six-minute walk test

Condition

Pulmonary Hypertension

Intervention

Sildenafil Citrate

Study Arms / Comparison Groups

 Sildenafil Citrate
Description:  Sildenafil Citrate 40 mg t.i.d. oral

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

200

Start Date

April 2009

Completion Date

July 2016

Primary Completion Date

July 2016

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Javier Bermejo, MD, PhD, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT00862043

Organization ID

FIBHGM-SIOVAC

Secondary IDs

2007-007033-40

Responsible Party

Sponsor

Study Sponsor

Hospital General Universitario Gregorio Marañon

Collaborators

 Instituto de Salud Carlos III

Study Sponsor

Javier Bermejo, MD, PhD, Principal Investigator, Hospital General Universitario Gregorio Maranon


Verification Date

September 2016