Heart Failure, CongestiveNCT00455611
Effects of CPAP on Ventricular Function Modifications
A study testing CPAP (Continuous Positive Airway Pressure) in people with Heart Failure, Congestive, run by Ospedale S. Giovanni Bosco at 1 site in Italy.
Trial summary
To assess modifications of ventricular function induced by CPAP (Continuous Positive Airway Pressure). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- CPAP (Continuous Positive Airway Pressure)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- May 2006to Dec 2012
- Phase
- Interventional
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of heart failure
- Chronic heart failure
- Ejection fraction < 40%
Who cannot join
- Age < 18 years
- Permanent atrial fibrillation
- Infiltrative cardiomyopathy
- Mild/moderate chronic obstructive lung disease
- Chronic heart failure
- Diabetes mellitus
- Chronic kidney failure
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ospedale San Giovanni Bosco Medicina d'Urgenza
Turin, Piedmont, 10154
About this study
Official title: Evaluation of the Effects of Intra-thoracic Positive Pressure Applicated With CPAP (Continuous Positive Airway Pressure) on Ventricular Function in Patients With Chronic Heart Failure: Modification Induced on Baroreflex Sensitivity
To assess modifications of ventricular function induced by CPAP (Continuous Positive Airway Pressure).
Read the detailed description
There are still few studies on the effects of positive intra-thoracic pressure on ventricular function and spontaneous baroreflex sensitivity changes. Aim of the study is to evaluate, in patients with chronic heart failure with an ejection fraction < 40%, the modifications of ventricular function induced by CPAP (Continuos Positive Airway Pressure) application. All the measurament will be made in basal condition (without CPAP) and with CPAP administration at 10 cmH2O via an oro-nasal mask.
Echocardiograpich evaluation: morphologic and hemodynamic evaluation is obtained with an echocardiographic exmination. Left ventricular measurement will be assessed in M-mode, under two dimensional guide) according to American Society of Echocardiography guidelines. Left ventricular ejection fraction will be assessed with Simpson method.
Right ventricle morphology will be evaluated categorizing dimensions in a) normal, b) mild enlargement, c) severely increased and d) reduced. Right ventricle area will also be quantified in tele-diastole and in meso-sistole in apical 4 chamber and parasternal short-axis.
Baroreflex control of heart rate was assessed by "sequence method" analysis of continuous blood pressure recordings obtained in basal condition and during CPAP. Data obtained by non invasive assessment of arterial pressure will be analized and values of arterial systolic, diastolic pressure and pulsatory period for each cardiac cicle will be registered.
Assessment via "sequence method" is founded on identification, every 10 minutes, on sequences characterized by a progressive increase both in pressure both in RR interval or, conversely, by a progressive reduction of pressure and RR interval evaluated on 4 or more cardiac cicles.
- Conditions
- Heart Failure, Congestive
- Being tested
- CPAP (Continuous Positive Airway Pressure)
- Keywords
- Heart Failure, Congestive, Continuous Positive Airway Pressure, Baroreflex, Echocardiography
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP (Continuous Positive Airway Pressure)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of modification of ventricular function and baroreflex sensitivity of heart rate after CPAP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2007 (estimated)
- Study startMay 2006
- Primary completionDec 2012 (estimated)
Why it stopped: No patients enrolled in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale S. Giovanni Bosco
- Sponsor type
- University, hospital or other
- Investigators
- Federico Olliveri, MD, Study director, ospedale San Giovanni Bosco ASL4
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455611
- Sponsor's protocol ID
- gbosco4
- Status last verified
- Apr 2007
- First submitted
- 2 Apr 2007
- Last updated
- 8 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Intra-thoracic Positive Pressure Applicated With CPAP (Continuous Positive Airway Pressure) on Ventricular Function in Patients With Chronic Heart Failure: Modification Induced on Baroreflex Sensitivity
- ClinicalTrials.gov ID
- NCT00455611
- Acronym / sponsor ID
- gbosco4
- Conditions
- Heart Failure, Congestive
- Keywords
- Heart Failure, Congestive, Continuous Positive Airway Pressure, Baroreflex, Echocardiography
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled in the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ospedale S. Giovanni BoscoUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Dec 2012 (estimated)
- First posted
- 3 Apr 2007 (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.
To assess modifications of ventricular function induced by CPAP (Continuous Positive Airway Pressure).
Detailed description
There are still few studies on the effects of positive intra-thoracic pressure on ventricular function and spontaneous baroreflex sensitivity changes. Aim of the study is to evaluate, in patients with chronic heart failure with an ejection fraction < 40%, the modifications of ventricular function induced by CPAP (Continuos Positive Airway Pressure) application. All the measurament will be made in basal condition (without CPAP) and with CPAP administration at 10 cmH2O via an oro-nasal mask.
Echocardiograpich evaluation: morphologic and hemodynamic evaluation is obtained with an echocardiographic exmination. Left ventricular measurement will be assessed in M-mode, under two dimensional guide) according to American Society of Echocardiography guidelines. Left ventricular ejection fraction will be assessed with Simpson method.
Right ventricle morphology will be evaluated categorizing dimensions in a) normal, b) mild enlargement, c) severely increased and d) reduced. Right ventricle area will also be quantified in tele-diastole and in meso-sistole in apical 4 chamber and parasternal short-axis.
Baroreflex control of heart rate was assessed by "sequence method" analysis of continuous blood pressure recordings obtained in basal condition and during CPAP. Data obtained by non invasive assessment of arterial pressure will be analized and values of arterial systolic, diastolic pressure and pulsatory period for each cardiac cicle will be registered.
Assessment via "sequence method" is founded on identification, every 10 minutes, on sequences characterized by a progressive increase both in pressure both in RR interval or, conversely, by a progressive reduction of pressure and RR interval evaluated on 4 or more cardiac cicles.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of heart failure
- Chronic heart failure
- Ejection fraction < 40%
Key exclusion criteria (7 listed)
- Age < 18 years
- Permanent atrial fibrillation
- Infiltrative cardiomyopathy
- Mild/moderate chronic obstructive lung disease
- Chronic heart failure
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 |
|---|---|---|
| CPAP (Continuous Positive Airway Pressure) | Device | – |
Primary outcome
Evaluation of modification of ventricular function and baroreflex sensitivity of heart rate after CPAP administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
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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.
Federico Olliveri, MD study director
ospedale San Giovanni Bosco ASL4
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP (Continuous Positive Airway Pressure) in people with Heart Failure, Congestive, run by Ospedale S. Giovanni Bosco at 1 site in Italy.
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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of modification of ventricular function and baroreflex sensitivity of heart rate after CPAP administration. 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 8 Mar 2013.