We will investigate the effect of sildenafil on pulmonary artery pressure in Heart failure patients (impaired heart function). Patients will be recruited from the Heart Failure clinic at Castle Hill Hospital if they have evidence of heart dysfunction and tricuspid regurgitation (allowed pulmonary artery pressure measurement by echocardiography) will be enrolled. MedDRA version: 9.1 Level: LLT Classification code 10002034 Term: Anaemia MedDRA version: 9.1 Level: LLT Classification code 10040756
Conditions
Interventions
Trade Name: revatio@ (sildenafil as citrate)
Product Name: sildenafil (as citrate)
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the p
Sponsors
Hull and East Yorkshire NHS Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: - Stable heart failure. - LVEF 600pg/ml. - Tricuspid Regurgitation velocity must be measurable reliably by echocardiography to estimate the pulmonary artery systolic. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion - Primary valve disease. - Oxygen saturation of 170/110). - Patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases). - Patients currently on bosentan therapy. - Patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease) or in patients who have conditions, which may predispose them to priapism (such as sickle cell anemia, multiple myeloma or leukemia). - Pregnant woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to investigate the effects of sildenafil citrate (a vasodilator licensed to treat erectile dysfunction and primary pulmonary artery hypertension) compared to placebo on pulmonary artery pressures and right ventricular function at rest and during a low level exercise test on air and during mild hypoxia (15% oxygen), in patients with heart failure. 15% oxygen concentration is chosen as this is the concentration of oxygen present in aeroplane cabins during high altitude flight and we have previoulsy validate this model as safe.;Secondary Objective: Is the proposed model robust enough to become an industry standard for Phase II clinical trials of secondary pulmonary hypertension? What is the pattern of response of pulmonary artery pressure, pulmonary vascular resistance and right ventricular function to exercise and hypoxia and to what extent is this related to mitral regurgitation and left ventricular filling pressures?;Primary end point(s): The primary outcome will be the effect of sildenafil citrate compared to placebo on systolic pulmonary artery pressure during low-level, steady-state exercise while breathing 15% oxygen. The systolic pulmonary artery pressure will be assessed by the measurement of the tricuspid regurgitation peak velocity added with the estimated right atrial pressure by echocardiography (=4*(tricuspid peak velocity)2+right atrial pressure. | — |
Countries
United Kingdom
Outcome results
None listed