CClinicalTrials.gg
CompletedNCT01185925Updated Aug 5, 2011

Exercise Oscillatory Breathing and Sildenafil in Heart Failure

A Phase 2 interventional study of Sildenafil and Placebo in Heart Failure, sponsored by University of Milan. Completed. Open to male participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-08-05.

Sponsored by University of Milan · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
Male
01

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.

02

Conditions studied

  • Heart Failure

Browse trials for

Keywords

  • PDE5-inhibition
  • exercise ventilation
  • heart failure
  • sildenafil
  • pulmonary hemodynamics
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 32 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University of Milan is the lead sponsor of 177 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Control Group

    Drug: Placebo

  • Active comparator
    sildenafil, pde5 inhibitor

    treatment group; sildenafil 50 mg three times a day for 1 year

    Drug: Sildenafil

Interventions

  • DrugSildenafil

    Sildenafil, 50 mg 3 times/day

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Drug Effect on Oscillatory Breathing during Exercise

    Time frame: 1 year follow-up

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01185925
Lead sponsor
University of Milan
First posted
Aug 20, 2010
Start date
Apr 2008
Primary completion
Dec 2009
Completion
Jun 2010
Last update
Aug 5, 2011
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion