Heart FailureNCT00679549
The Role of Sleep Apnea in the Acute Exacerbation of Heart Failure
A study testing CPAP Therapy in people with Heart Failure and Obstructive Sleep Apnea, run by Ohio State University at 1 site in United States.
Trial summary
This study will evaluate whether treating sleep apnea while in the hospital would help heart failure, and assist recovery from the worsening of the heart function more than the current clinical standard of waiting for treatment until the subject have left the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Obstructive Sleep Apnea, Heart Failure, Congestive
- What is being tested?
- CPAP Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to 22 Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously unrecognized OSA with an Apnea Hypopnea Index (AHI) > 15 events per hour on the attended in-hospital sleep study. Patients with apnea index of less than 5 events / hour are excluded (see design consideration for rationale)
- Projected length of stay 3 days or more on the morning following the cardio-respiratory sleep study
- Ongoing or planned targeted treatment for heart failure including one of the following: IV diuretics, IV infusion of inotropes or vasodilators, or planned revascularization, or device therapy
Who cannot join
- Patients who are already diagnosed with OSA
- Patients with Central Sleep Apnea
- Patients with diastolic only heart failure
- Cardiogenic shock and hemodynamic instability with MAP less than 55 mmHg off vasopressors, or concurrently on vasopressor treatment, left ventricular assist devices, or intra-aortic Balloon Pump. Inotropic agents will not constitute an exclusion criterion. Patients will be eligible once off vasopressors.
- Acute respiratory failure or insufficiency defined by P/F (PaO2/FIO2) ratio less than 250, or FIO2 requirement more than 50%
- Overt neurological deficit
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- Renal failure requiring renal replacement therapy; Patients will not be excluded if they were undergoing ultra-filtration for volume removal
- Patients scheduled for procedures that will interfere with post randomization measurement: This includes scheduled coronary bypass surgery, or expected left ventricular assist device placement.
- Patients who arrived from a long-term care facility or expected to be discharged to one; and patients who have very poor functional outcome precluding ability to use the CPAP device independently.
- Patients on long term or "bridging" inotropic infusion, or short life expectancy due to concomitant illness
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate whether treating sleep apnea while in the hospital would help heart failure, and assist recovery from the worsening of the heart function more than the current clinical standard of waiting for treatment until the subject have left the hospital.
Heart failure affects more than 2% of the US population and is the only cardiovascular disorder with rising incidence. The annual cost of CHF in 2005 was $ 27.9 billion, large percentage of which is the cost of hospitalizations for exacerbation of CHF. Half of patients with CHF have some form of sleep apnea, and most of them go undiagnosed. Patients with CHF and OSA benefit from treatment with CPAP as an outpatient. The society can benefit from developing recommendations for approaching sleep apnea in the hospitalized CHF patient, which may shorten length of stay, improve functional status of discharged patient, and reduce rehospitalizations.
Read the detailed description
Target population:
Patients admitted to the OSU Heart Hospital with ADHF routinely undergo a cardiorespiratory sleep study to identify OSA. Patients with ADHF who are newly diagnosed with OSA during the same hospital stay are eligible for this study.
Enrollment:
Given the presence of significant previously unrecognized OSA in 62% of patients hospitalized with ADHF, we expect to need to screen 270 patient volunteers to recruit 170 patients with OSA.
Eligibility for randomization: The criteria for ADHF is admission diagnosis of heart failure; a chief complaint of dyspnea; and ejection fraction of 45% or less. Additionally, elevated left ventricular pressure as indicated by at least one sign and one symptom of volume overload (pedal edema, crackles, consistent chest X-ray, increased left ventricular end-diastolic diameter, or elevated BNP level) is required [46].
- Being tested
- CPAP Therapy
- Keywords
- Heart Failure, Obstructive Sleep Apnea, OSA, CHF, Sleep apnea, CHD
- Medical subject headings
- Heart Failure, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP TherapyDevice
Also called CPAP Device
CPAP therapy is provided as an inpatient.
| Study group | Role | What they receive |
|---|---|---|
| DEVICE | Experimental | Provided CPAP as an inpatient Receives: Device: CPAP Therapy |
| Control | No intervention | No device provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction (LVEF)
Using the modified Simpson method. LVEF is calculated as (Left ventricular end diastolic volume (LVEDV)-left ventricular end systolic volume (LVESV)/left ventricular end diastolic volume (LVEDV) *100.
the measurement unit of LVEF is %.
Measured: at baseline and 3 days post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startMar 2008
- Primary completion22 Mar 2014
- Study completion22 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rami Khayat, Ohio State University
- Investigators
- Rami N Khayat, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679549
- Sponsor's protocol ID
- 2008H0011
- Status last verified
- Apr 2019
- First submitted
- 15 May 2008
- Last updated
- 14 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sleep Apnea in the Acute Exacerbation of Heart Failure
- ClinicalTrials.gov ID
- NCT00679549
- Acronym / sponsor ID
- 2008H0011
- Keywords
- Heart Failure, Obstructive Sleep Apnea, OSA, CHF, Sleep apnea, CHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- 22 Mar 2014 (actual)
- Study completion
- 22 Mar 2014 (actual)
- First posted
- 19 May 2008 (estimated)
- Results
- Posted 14 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether treating sleep apnea while in the hospital would help heart failure, and assist recovery from the worsening of the heart function more than the current clinical standard of waiting for treatment until the subject have left the hospital.
Heart failure affects more than 2% of the US population and is the only cardiovascular disorder with rising incidence. The annual cost of CHF in 2005 was $ 27.9 billion, large percentage of which is the cost of hospitalizations for exacerbation of CHF. Half of patients with CHF have some form of sleep apnea, and most of them go undiagnosed. Patients with CHF and OSA benefit from treatment with CPAP as an outpatient. The society can benefit from developing recommendations for approaching sleep apnea in the hospitalized CHF patient, which may shorten length of stay, improve functional status of discharged patient, and reduce rehospitalizations.
Detailed description
Target population:
Patients admitted to the OSU Heart Hospital with ADHF routinely undergo a cardiorespiratory sleep study to identify OSA. Patients with ADHF who are newly diagnosed with OSA during the same hospital stay are eligible for this study.
Enrollment:
Given the presence of significant previously unrecognized OSA in 62% of patients hospitalized with ADHF, we expect to need to screen 270 patient volunteers to recruit 170 patients with OSA.
Eligibility for randomization: The criteria for ADHF is admission diagnosis of heart failure; a chief complaint of dyspnea; and ejection fraction of 45% or less. Additionally, elevated left ventricular pressure as indicated by at least one sign and one symptom of volume overload (pedal edema, crackles, consistent chest X-ray, increased left ventricular end-diastolic diameter, or elevated BNP level) is required [46].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEVICE | Experimental | Device: CPAP TherapyProvided CPAP as an inpatient |
| Control | No intervention | –No device provided |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previously unrecognized OSA with an Apnea Hypopnea Index (AHI) > 15 events per hour on the attended in-hospital sleep study. Patients with apnea index of less than 5 events / hour are excluded (see design consideration for rationale)
- Projected length of stay 3 days or more on the morning following the cardio-respiratory sleep study
- Ongoing or planned targeted treatment for heart failure including one of the following: IV diuretics, IV infusion of inotropes or vasodilators, or planned revascularization, or device therapy
Key exclusion criteria (10 listed)
- Patients who are already diagnosed with OSA
- Patients with Central Sleep Apnea
- Patients with diastolic only heart failure
- Cardiogenic shock and hemodynamic instability with MAP less than 55 mmHg off vasopressors, or concurrently on vasopressor treatment, left ventricular assist devices, or intra-aortic Balloon Pump. Inotropic agents will not constitute an exclusion criterion. Patients will be eligible once off vasopressors.
- Acute respiratory failure or insufficiency defined by P/F (PaO2/FIO2) ratio less than 250, or FIO2 requirement more than 50%
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 TherapyAlso: CPAP DeviceCPAP therapy is provided as an inpatient. | Device | DEVICE |
Primary outcome
Left Ventricular Ejection Fraction (LVEF)
Time frame: at baseline and 3 days post randomization
Using the modified Simpson method. LVEF is calculated as (Left ventricular end diastolic volume (LVEDV)-left ventricular end systolic volume (LVESV)/left ventricular end diastolic volume (LVEDV) *100. the measurement unit of LVEF is %.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Rami N Khayat, MD principal investigator
Ohio State University
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 Therapy in people with Heart Failure and Obstructive Sleep Apnea, run by Ohio State University at 1 site in United States.
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 10 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 14 May 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Left Ventricular Ejection Fraction (LVEF) (time frame: at baseline and 3 days post randomization). 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 14 May 2019.