Exercise Oscillatory Breathing and Sildenafil in Heart Failure
NCT ID: NCT01185925
Last Updated: 2011-08-05
Study Results
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Basic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2008-04-30
2010-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Control Group
Placebo
Placebo
sildenafil, pde5 inhibitor
treatment group; sildenafil 50 mg three times a day for 1 year
Sildenafil
Sildenafil, 50 mg 3 times/day
Interventions
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Sildenafil
Sildenafil, 50 mg 3 times/day
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* negative exercise stress test prior to study initiation
* forced expiratory volume in 1 sec/forced vital capacity ratio \>70%;
* LVEF \< 45%.
Exclusion Criteria
* 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
30 Years
80 Years
MALE
No
Sponsors
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University of Milan
OTHER
Responsible Party
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Cardiopulmonary Unit, University of Milano
Other Identifiers
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14a
Identifier Type: -
Identifier Source: secondary_id
444-14
Identifier Type: -
Identifier Source: org_study_id
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