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OpenTrials
Completed

NCT Number: NCT01185925

Exercise Oscillatory Breathing and Sildenafil in Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

30 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil

Drug

Sildenafil, 50 mg 3 times/day

Placebo

Drug

Placebo

Primary outcomes

  1. Drug Effect on Oscillatory Breathing during Exercise

    Time frame: 1 year follow-up

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

PDE5-Inhibition With Sildenafil Reverses Exercise Oscillatory Breathing in Chronic Heart Failure: a Long-Term Cardiopulmonary Exercise Testing Placebo-Controlled Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Aug 20, 2010
Registry last updated
Aug 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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