Exercise Oscillatory Breathing and Sildenafil in Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sildenafil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring PDE5-inhibition, exercise ventilation, heart failure, sildenafil, pulmonary hemodynamics
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
sildenafil, pde5 inhibitor
Arm Description
Control Group
treatment group; sildenafil 50 mg three times a day for 1 year
Outcomes
Primary Outcome Measures
Drug Effect on Oscillatory Breathing during Exercise
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01185925
Brief Title
Exercise Oscillatory Breathing and Sildenafil in Heart Failure
Official Title
PDE5-Inhibition With Sildenafil Reverses Exercise Oscillatory Breathing in Chronic Heart Failure: a Long-Term Cardiopulmonary Exercise Testing Placebo-Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Milan
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
PDE5-inhibition, exercise ventilation, heart failure, sildenafil, pulmonary hemodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Control Group
Arm Title
sildenafil, pde5 inhibitor
Arm Type
Active Comparator
Arm Description
treatment group; sildenafil 50 mg three times a day for 1 year
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Intervention Description
Sildenafil, 50 mg 3 times/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Drug Effect on Oscillatory Breathing during Exercise
Time Frame
1 year follow-up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Exercise Oscillatory Breathing and Sildenafil in Heart Failure
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