Effect of Sildenafil on Pulmonary Artery Pressure during hypoxia and exercise in Chronic Heart Failure - Effect of sildenafil on PA pressure during exercise and hypoxia in CHF

• Conditions: 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: 9.1Level: LLTClassification code 10002034Term: Anaemia; MedDRA version: 9.1Level: LLTClassification code 10040756Term: Sinusitis NOS; MedDRA version: 9.1Level: LLTClassification code 10016807Term: Fluid retention; MedDRA version: 9.1Level: LLTClassification code 10022437Term: Insomnia; MedDRA version: 9.1Level: LLTClassification code 10016998Term: Forehead headache; MedDRA version: 9.1Level: LLTClassification code 10010108Term: Common migraine; MedDRA version: 9.1Level: LLTClassification code 10002855Term: Anxiety; MedDRA version: 9.1Level: LLTClassification code 10044565Term: Tremor; MedDRA version: 9.1Level: LLTClassification code 10033987Term: Paresthesia

• Registration Number: EUCTR2008-008135-28-GB
• Lead Sponsor: Hull and East Yorkshire NHS Hospitals Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-15
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Stable heart failure.
- LVEF <40% or NT-proBNP >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
- Primary valve disease.
- Oxygen saturation of <90% on air at rest (severe pulmonary disease) in whom a normal hypoxiama state could not be assessed.
- Patients with severe tricuspid regurgitation, in whom pulmonary artery pressure may be underestimated.
- Arrhythmias precluding accurate measurement by echocardiography.
- Patients with severe optic neuropathy (non-arteritic anterior ischemic optic neuropathy (NAION).
- Patients prescribed long-acting nitrates within the previous 24 hours or short-acting agents within 6 hours(Interaction with sildenafil).
- Patients with ritonavir treatment (ritonavir is protease inhibitor with a highly potent CYP3A4)(Interaction with sildenafil).
- Patients receiving inducers such as barbiturates, carbamazepine, phenytoin, efavirenz, nevirapine, rifampin,rifabutin (CYP3A4 inductors) will be excluded as patients receiving ketoconazole, itraconazole, ritonavir (CYP3A4 inhibitors).
- Patients prescribed a sildenafil derivative within 24h time period before study procedures are followed.
- Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months.
- Patients with coronary artery disease causing unstable angina.
- Patients with hypertension (BP >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified