Exercise Oscillatory Breathing and Sildenafil in Heart Failure
- Registration Number
- NCT01185925
- Lead Sponsor
- University of Milan
- Brief Summary
Exercise oscillatory breathing (EOB) is a ventilatory abnormality that occurs in approximately 20% of heart failure (HF) patients and carries a very unfavourable prognosis.
Pathophysiology seems quite complex and putative mechanisms include increased pulmonary capillary pressure and pulmonary vasoconstriction, circulatory blood-flow fluctuations in the pulmonary arterial system and instability of ventilatory control.
Inhibition of the phosphodiesterase 5 (PDE5) isoenzyme favourably regulates pulmonary vascular tone and permeability through over signaling of the endothelial nitric oxide pathway. The investigators tested the hypothesis that sildenafil would reverse the EOB pattern in patients with HF and pulmonary hypertension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
Inclusion Criteria
- consent to participate in the study after detailed information about benefits and risks
- negative exercise stress test prior to study initiation
- forced expiratory volume in 1 sec/forced vital capacity ratio >70%;
- LVEF < 45%.
Exclusion Criteria
- inability to complete a maximal exercise test
- resting systolic blood pressure > 140 or <110 mmHg
- therapy with nitrate preparations
- history of sildenafil intolerance
- significant lung or valvular diseases
- neuromuscular disorders or peripheral vascular disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Control Group sildenafil, pde5 inhibitor Sildenafil treatment group; sildenafil 50 mg three times a day for 1 year
- Primary Outcome Measures
Name Time Method Drug Effect on Oscillatory Breathing during Exercise 1 year follow-up
- Secondary Outcome Measures
Name Time Method