Heart FailurePhase 2NCT01185925
Exercise Oscillatory Breathing and Sildenafil in Heart Failure
A Phase 2 study testing Sildenafil in people with Heart Failure, run by University of Milan.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 years, men only
- Conditions the study is for
- Heart Failure
- What is being tested?
- Sildenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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
About this study
Official title: PDE5-Inhibition With Sildenafil Reverses Exercise Oscillatory Breathing in Chronic Heart Failure: a Long-Term Cardiopulmonary Exercise Testing Placebo-Controlled Study
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
- Heart Failure
- Being tested
- Sildenafil, Placebo
- Keywords
- PDE5-inhibition, exercise ventilation, heart failure, sildenafil, pulmonary hemodynamics
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Sildenafil, 50 mg 3 times/day
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Control Group Receives: Drug: Placebo |
| sildenafil, pde5 inhibitor | Active comparator | treatment group; sildenafil 50 mg three times a day for 1 year Receives: Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Effect on Oscillatory Breathing during Exercise
Measured: 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startApr 2008
- Primary completionDec 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185925
- Sponsor's protocol ID
- 444-14
- Other IDs
- 14a
- Status last verified
- May 2008
- First submitted
- 19 Aug 2010
- Last updated
- 5 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PDE5-Inhibition With Sildenafil Reverses Exercise Oscillatory Breathing in Chronic Heart Failure: a Long-Term Cardiopulmonary Exercise Testing Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT01185925
- Acronym / sponsor ID
- 444-14
- Conditions
- Heart Failure
- Keywords
- PDE5-inhibition, exercise ventilation, heart failure, sildenafil, pulmonary hemodynamics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 20 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboControl Group |
| sildenafil, pde5 inhibitor | Active comparator | Drug: Sildenafiltreatment group; sildenafil 50 mg three times a day for 1 year |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SildenafilSildenafil, 50 mg 3 times/day | Drug | sildenafil, pde5 inhibitor |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Drug Effect on Oscillatory Breathing during Exercise
Time frame: 1 year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sildenafil in people with Heart Failure, run by University of Milan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Effect on Oscillatory Breathing during Exercise (time frame: 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2011.