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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
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

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

30 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

    First Posted
    August 19, 2010
    Last Updated
    August 4, 2011
    Sponsor
    University of Milan
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    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

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