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Exercise Oscillatory Breathing and Sildenafil in Heart Failure

NCT01185925 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2011-08-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Sildenafil

Sildenafil, 50 mg 3 times/day

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • University of Milan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-12-31
Completion
2010-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01185925 on ClinicalTrials.gov