Heart FailurePhase 4OPTIMAL-HFNCT01807897
Oxygen Versus PAP for Sleep Apnea in Heart Failure
A Phase 4 study testing Continuous positive airway pressure, Nocturnal supplemental oxygen and Healthy Lifestyle and Sleep Education in people with Heart Failure and Sleep Apnea Syndromes, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
The purpose of this study is to compare three treatment modalities for central, or mixed obstructive and central, sleep apnea in patients with chronic heart failure and reduced ejection fraction. The modalities to be tested are nocturnal supplemental oxygen (NSO) and continuous positive airway pressure (CPAP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Sleep Apnea Syndromes
- What is being tested?
- Continuous positive airway pressure, Nocturnal supplemental oxygen and Healthy Lifestyle and Sleep Education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jun 2014to 30 Jun 2020
- Phase
- Phase 4
- 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
- Veteran receiving care within the Veterans Health Administration healthcare system
- Age 18 years
- Physician diagnosis of chronic heart failure, American Heart Association Stage C-D
- LVEF <45%
- No change in active cardiac medications for 4 weeks prior to randomization
- Ability to provide informed consent
- Moderate to severe central or mixed central and obstructive sleep apnea, defined as an apnea-hypopnea index (AHI) 15 events per hour, with a central AHI >5 events/hour
Who cannot join
- Hospitalization for acute decompensated HF within previous 30 days
- Hospitalization for myocardial infarction or cardiac surgery within previous 90 days
- Presence of a left ventricular assist device
- History of heart transplantation
- Poorly controlled hypertension (>170/>110)
- Poorly controlled diabetes (HbA1c > 9.0)
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- Severe renal failure with estimated glomerular filtration rate <30 ml/min
- Prior stroke with functional impairment or other severe, uncontrolled medical problems that may impair ability to participate in the study exams, based on medical history and review of medical records
- Severe chronic insomnia, with reported usual sleep duration <4 hours
- Severe daytime sleepiness, defined as Epworth Sleepiness Scale score 18 or higher or a report of falling asleep driving during the previous year, and deemed a safety risk by study physician
- Awake resting oxyhemoglobin saturation <89%
- Pregnancy
- Smoking by subject or other person in the subject's bedroom, or other open flame in bedroom
- Current use of a positive airway pressure device (including continuous or bi-level positive airway pressure or adaptive servo-ventilation) or supplemental oxygen therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516
About this study
Official title: Oxygen Versus PAP for Treatment of Sleep Apnea in Chronic Heart Failure
The purpose of this study is to compare three treatment modalities for central, or mixed obstructive and central, sleep apnea in patients with chronic heart failure and reduced ejection fraction. The modalities to be tested are nocturnal supplemental oxygen (NSO) and continuous positive airway pressure (CPAP). The main outcome measures will be left ventricular ejection fraction on echocardiogram and peak oxygen consumption on cardiopulmonary exercise testing.
Read the detailed description
Chronic heart failure (HF) is a highly prevalent disease, with a lifetime risk of approximately 20%. Sleep apnea is a common co-morbid condition, occurring in approximately half of patients with chronic HF, and often has predominantly central or mixed obstructive and central characteristics. Although it is associated with increased mortality in patients with HF, sleep apnea is usually asymptomatic and patients are therefore often unwilling to accept standard therapy with positive airway pressure. At the outset of this study, there were three treatment modalities currently recommended by the American Academy of Sleep Medicine for the treatment of predominantly central sleep apnea in HF patients: nocturnal supplemental oxygen (NSO), continuous positive airway pressure (CPAP) and adaptive servo-ventilation (ASV). Recently, ASV was found to increase mortality in patients with heart failure with reduced ejection fraction and central sleep apnea. There are only limited data on the comparative efficacy and tolerability of these three modalities. The present study is designed to compare these modalities with respect to effects on ventricular function, exercise capacity, and other measures of cardiovascular risk.
- Conditions
- Heart Failure, Sleep Apnea Syndromes
- Being tested
- Continuous positive airway pressure, Nocturnal supplemental oxygen, Healthy Lifestyle and Sleep Education
- Keywords
- Heart Failure, Sleep Apnea, Ventricular Ejection Fraction, Exercise Test
- Medical subject headings
- Heart Failure, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureDevice
Also called CPAP
Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index
Nocturnal supplemental oxygenDevice
Also called NSO
Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia
Healthy Lifestyle and Sleep EducationBehavioural
Also called HLSE
A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Experimental | Nocturnal continuous positive airway pressure Receives: Device: Continuous positive airway pressure; Behavioral: Healthy Lifestyle and Sleep Education |
| NSO | Experimental | Nocturnal supplemental oxygen Receives: Device: Nocturnal supplemental oxygen; Behavioral: Healthy Lifestyle and Sleep Education |
| HLSE | Other | Healthy lifestyle and sleep education control Receives: Behavioral: Healthy Lifestyle and Sleep Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction
Standard transthoracic 2-dimensional and Doppler echocardiography will be performed. M-mode measurements of LV dimensions will be performed and analyzed according to the American Society of Echocardiography recommendations and LVEF measured using the modified Simpson's method. Measurement is change from baseline in LVEF.
Measured: 3 months
Secondary outcomes (2)
Peak Oxygen Consumption (VO2 Peak)
Treadmill exercise testing will be performed using a motor-driven treadmill and a modified Naughton protocol, with a lightweight disposable pneumotach device positioned in the participant's mouth interfaced with a metabolic cart. Change in VO2 peak between baseline and final visit will be the co-primary outcome of the study. Secondary outcome measures from cardiopulmonary exercise testing include VO2 at anaerobic threshold and VE/VCO2 slope.
Measured: 3 months
24-hour Ambulatory Blood Pressure
24-hour blood pressure will be measured using a blood pressure cuff that is connected by rubber tubing to a small pressure monitoring device, programmed to measure BP at 20 minute intervals during the day and 30 minute intervals at night (11 PM to 7 AM) for a period of 24 hours. The investigators will assess 24-hour mean arterial pressure as the primary blood pressure outcome, with additional assessment of nocturnal versus diurnal blood pressure effects.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study start23 Jun 2014
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
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 VA Office of Research and DevelopmentThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Continuous positive airway pressure (CPAP) and supplemental oxygen
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Daniel J Gottlieb, MD MPH, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807897
- Sponsor's protocol ID
- CLIN-008-12S
- Acronym
- OPTIMAL-HF
- Status last verified
- Dec 2022
- First submitted
- 1 Mar 2013
- Last updated
- 25 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Versus PAP for Treatment of Sleep Apnea in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01807897
- Acronym / sponsor ID
- OPTIMAL-HF / CLIN-008-12S
- Conditions
- Heart Failure, Sleep Apnea Syndromes
- Keywords
- Heart Failure, Sleep Apnea, Ventricular Ejection Fraction, Exercise Test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 23 Jun 2014 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Posted 25 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare three treatment modalities for central, or mixed obstructive and central, sleep apnea in patients with chronic heart failure and reduced ejection fraction. The modalities to be tested are nocturnal supplemental oxygen (NSO) and continuous positive airway pressure (CPAP). The main outcome measures will be left ventricular ejection fraction on echocardiogram and peak oxygen consumption on cardiopulmonary exercise testing.
Detailed description
Chronic heart failure (HF) is a highly prevalent disease, with a lifetime risk of approximately 20%. Sleep apnea is a common co-morbid condition, occurring in approximately half of patients with chronic HF, and often has predominantly central or mixed obstructive and central characteristics. Although it is associated with increased mortality in patients with HF, sleep apnea is usually asymptomatic and patients are therefore often unwilling to accept standard therapy with positive airway pressure. At the outset of this study, there were three treatment modalities currently recommended by the American Academy of Sleep Medicine for the treatment of predominantly central sleep apnea in HF patients: nocturnal supplemental oxygen (NSO), continuous positive airway pressure (CPAP) and adaptive servo-ventilation (ASV). Recently, ASV was found to increase mortality in patients with heart failure with reduced ejection fraction and central sleep apnea. There are only limited data on the comparative efficacy and tolerability of these three modalities. The present study is designed to compare these modalities with respect to effects on ventricular function, exercise capacity, and other measures of cardiovascular risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Continuous positive airway pressure (CPAP) and supplemental oxygen
| Arm | Type | Receives |
|---|---|---|
| CPAP | Experimental | Device: Continuous positive airway pressure, Behavioral: Healthy Lifestyle and Sleep EducationNocturnal continuous positive airway pressure |
| NSO | Experimental | Device: Nocturnal supplemental oxygen, Behavioral: Healthy Lifestyle and Sleep EducationNocturnal supplemental oxygen |
| HLSE | Other | Behavioral: Healthy Lifestyle and Sleep EducationHealthy lifestyle and sleep education control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Veteran receiving care within the Veterans Health Administration healthcare system
- Age 18 years
- Physician diagnosis of chronic heart failure, American Heart Association Stage C-D
- LVEF <45%
- No change in active cardiac medications for 4 weeks prior to randomization
Key exclusion criteria (14 listed)
- Hospitalization for acute decompensated HF within previous 30 days
- Hospitalization for myocardial infarction or cardiac surgery within previous 90 days
- Presence of a left ventricular assist device
- History of heart transplantation
- Poorly controlled hypertension (>170/>110)
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 |
|---|---|---|
| Continuous positive airway pressureAlso: CPAPNocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index | Device | CPAP |
| Nocturnal supplemental oxygenAlso: NSONocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia | Device | NSO |
| Healthy Lifestyle and Sleep EducationAlso: HLSEA 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle | Behavioural | CPAP, HLSE, NSO |
Primary outcome
Left Ventricular Ejection Fraction
Time frame: 3 months
Standard transthoracic 2-dimensional and Doppler echocardiography will be performed. M-mode measurements of LV dimensions will be performed and analyzed according to the American Society of Echocardiography recommendations and LVEF measured using the modified Simpson's method. Measurement is change from baseline in LVEF.
2 secondary outcomes
Peak Oxygen Consumption (VO2 Peak)
Time frame: 3 months
24-hour Ambulatory Blood Pressure
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Daniel J Gottlieb, MD MPH principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous positive airway pressure, Nocturnal supplemental oxygen and Healthy Lifestyle and Sleep Education in people with Heart Failure and Sleep Apnea Syndromes, run by VA Office of Research and Development at 2 sites 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 7 inclusion and 14 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 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2023). 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 (time frame: 3 months). 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 25 Jan 2023.