Exercise Oscillatory Breathing and Sildenafil in Heart Failure
PDE5-Inhibition With Sildenafil Reverses Exercise Oscillatory Breathing in Chronic Heart Failure: a Long-Term Cardiopulmonary Exercise Testing Placebo-Controlled Study
2 other identifiers
interventional
32
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 heart-failure
Started Apr 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 19, 2010
CompletedFirst Posted
Study publicly available on registry
August 20, 2010
CompletedAugust 5, 2011
May 1, 2008
1.7 years
August 19, 2010
August 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Drug Effect on Oscillatory Breathing during Exercise
1 year follow-up
Study Arms (2)
Placebo
PLACEBO COMPARATORControl Group
sildenafil, pde5 inhibitor
ACTIVE COMPARATORtreatment group; sildenafil 50 mg three times a day for 1 year
Interventions
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 19, 2010
First Posted
August 20, 2010
Study Start
April 1, 2008
Primary Completion
December 1, 2009
Study Completion
June 1, 2010
Last Updated
August 5, 2011
Record last verified: 2008-05