Cardiovascular DiseasePhase 2HeartBEATNCT01086800
Heart Biomarker Evaluation in Apnea Treatment
A Phase 2 study testing Healthy Lifestyles and Sleep Education plus PAP, Healthy Lifestyles and Sleep Education plus Supplemental Oxygen and Healthy Lifestyles and Sleep Education in people with Cardiovascular Disease and Obstructive Sleep Apnea, run by Brigham and Women's Hospital at 4 sites in United States.
Trial summary
This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Cardiovascular Disease, Obstructive Sleep Apnea, Coronary Artery Disease
- What is being tested?
- Healthy Lifestyles and Sleep Education plus PAP, Healthy Lifestyles and Sleep Education plus Supplemental Oxygen and Healthy Lifestyles and Sleep Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2010to Aug 2012
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- established Coronary Artery Disease or established cardiovascular disease risk factors
- home sleep test that showed moderately severe sleep apnea
Who cannot join
- poorly controlled health
- currently using supplemental oxygen or PAP for OSA
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21224
Partners HealthCare
Boston, Massachusetts, 02115
VA Boston Healthcare System
Boston, Massachusetts, 02132
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: Phase II Trial of Sleep Apnea Treatment to Reduce Cardiovascular Morbidity
This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.
Read the detailed description
This is a Phase II randomized controlled trial that will evaluate the effects of supplemental nocturnal oxygen or Positive Airway Pressure (PAP) therapy, compared to optimal medical preventive therapy for Cardiovascular Disease (CVD) risk, on biomarkers of CVD risk in Obstructive Sleep Apnea (OSA) patients at high risk for CVD events. The study will focus on patients with moderate to severe OSA but only mild OSA symptoms.
Eligible participants have a history or symptoms of heart disease AND have symptoms of sleep apnea or snoring. Participants will be contributing to medical knowledge about different options that can be used to improve heart disease in people with sleep apnea.
- Being tested
- Healthy Lifestyles and Sleep Education plus PAP, Healthy Lifestyles and Sleep Education plus Supplemental Oxygen, Healthy Lifestyles and Sleep Education
- Medical subject headings
- Cardiovascular Diseases, Sleep Apnea, Obstructive, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Lifestyles and Sleep Education plus PAPOther
Participants randomized to this arm will be educated on PAP and then use PAP for 3 months. They will also receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines.
Healthy Lifestyles and Sleep Education plus Supplemental OxygenOther
Participants randomized to this arm will be educated on nocturnal supplemental oxygen and then use oxygen for 3 months. They also will receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines.
Healthy Lifestyles and Sleep EducationOther
Participants randomized to this arm will receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines.
| Study group | Role | What they receive |
|---|---|---|
| HLSE plus PAP | Other | Not described Receives: Other: Healthy Lifestyles and Sleep Education plus PAP |
| HLSE plus Oxygen | Other | Not described Receives: Other: Healthy Lifestyles and Sleep Education plus Supplemental Oxygen |
| Healthy Lifestyles and Sleep Education | Other | Not described Receives: Other: Healthy Lifestyles and Sleep Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effects of nocturnal supplemental oxygen and PAP versus optimized medical management on biomarkers of cardiovascular risk, including:
- 24 hour blood pressure (BP) profile
- Markers of systemic inflammation
- Markers of oxidative stress
- Prothrombotic markers
- Sympathetic nervous system activity
- Cardiac rhythm, impulse generation and ischemia
- Dyslipidemia
- Glucose regulation
- Myocardial stress
Measured: 3 months
Secondary outcomes (2)
Compare the effects of nocturnal supplemental oxygen and PAP versus standard care on patient-reported outcomes, including:
- vitality
- self reported sleepiness
Measured: 3 months
Compare nocturnal supplemental oxygen and PAP on measures of:
- efficacy (AHI, hypoxemia)
- adherence
- side 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 posted15 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, Partners HealthCare, Johns Hopkins University, VA Boston Healthcare System
- Responsible party
- Principal investigator, Susan Redline, Brigham and Women's Hospital
- Investigators
- Susan Redline, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086800
- Sponsor's protocol ID
- 1RC2HL101417-01
- Acronym
- HeartBEAT
- Status last verified
- Feb 2013
- First submitted
- 12 Mar 2010
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hilmisson H, Thomas RJ, Magnusdottir S. Cardiopulmonary coupling-calculated sleep stability and nocturnal heart rate kinetics as a potential indicator for cardiovascular health: a relationship with blood pressure dipping. Front Sleep. 2024 Aug 1;3:1230958. doi: 10.3389/frsle.2024.1230958. eCollection 2024.
PubMed 41424523Ni YN, Lei F, Tang X, Liang Z, Thomas RJ. The association between the effective apnea-hypopnea index and blood pressure reduction efficacy following CPAP/oxygen treatment. Sleep Med. 2024 May;117:46-52. doi: 10.1016/j.sleep.2024.02.046. Epub 2024 Mar 13.
PubMed 38507976Schmickl CN, Orr JE, Sands SA, Alex RM, Azarbarzin A, McGinnis L, White S, Mazzotti DR, Nokes B, Owens RL, Gottlieb DJ, Malhotra A. Loop Gain as a Predictor of Blood Pressure Response in Patients Treated for Obstructive Sleep Apnea: Secondary Analysis of a Clinical Trial. Ann Am Thorac Soc. 2024 Feb;21(2):296-307. doi: 10.1513/AnnalsATS.202305-437OC.
PubMed 37938917Magnusdottir S, Thomas RJ, Hilmisson H. Can improvements in sleep quality positively affect serum adiponectin-levels in patients with obstructive sleep apnea? Sleep Med. 2021 Aug;84:324-333. doi: 10.1016/j.sleep.2021.05.032. Epub 2021 May 29.
PubMed 34225174Magnusdottir S, Hilmisson H, Thomas RJ. Cardiopulmonary coupling-derived sleep quality is associated with improvements in blood pressure in patients with obstructive sleep apnea at high-cardiovascular risk. J Hypertens. 2020 Nov;38(11):2287-2294. doi: 10.1097/HJH.0000000000002553.
PubMed 32649638Gottlieb DJ, Punjabi NM, Mehra R, Patel SR, Quan SF, Babineau DC, Tracy RP, Rueschman M, Blumenthal RS, Lewis EF, Bhatt DL, Redline S. CPAP versus oxygen in obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2276-85. doi: 10.1056/NEJMoa1306766.
PubMed 24918372
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Sleep Apnea Treatment to Reduce Cardiovascular Morbidity
- ClinicalTrials.gov ID
- NCT01086800
- Acronym / sponsor ID
- HeartBEAT / 1RC2HL101417-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Case Western Reserve University, Partners HealthCare, Johns Hopkins University, VA Boston Healthcare System
- Study start
- Feb 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Mar 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.
This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.
Detailed description
This is a Phase II randomized controlled trial that will evaluate the effects of supplemental nocturnal oxygen or Positive Airway Pressure (PAP) therapy, compared to optimal medical preventive therapy for Cardiovascular Disease (CVD) risk, on biomarkers of CVD risk in Obstructive Sleep Apnea (OSA) patients at high risk for CVD events. The study will focus on patients with moderate to severe OSA but only mild OSA symptoms.
Eligible participants have a history or symptoms of heart disease AND have symptoms of sleep apnea or snoring. Participants will be contributing to medical knowledge about different options that can be used to improve heart disease in people with sleep apnea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HLSE plus PAP | Other | Other: Healthy Lifestyles and Sleep Education plus PAP |
| HLSE plus Oxygen | Other | Other: Healthy Lifestyles and Sleep Education plus Supplemental Oxygen |
| Healthy Lifestyles and Sleep Education | Other | Other: Healthy Lifestyles and Sleep Education |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- established Coronary Artery Disease or established cardiovascular disease risk factors
- home sleep test that showed moderately severe sleep apnea
Key exclusion criteria (2 listed)
- poorly controlled health
- currently using supplemental oxygen or PAP for OSA
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 |
|---|---|---|
| Healthy Lifestyles and Sleep Education plus PAPParticipants randomized to this arm will be educated on PAP and then use PAP for 3 months. They will also receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines. | Other | HLSE plus PAP |
| Healthy Lifestyles and Sleep Education plus Supplemental OxygenParticipants randomized to this arm will be educated on nocturnal supplemental oxygen and then use oxygen for 3 months. They also will receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines. | Other | HLSE plus Oxygen |
| Healthy Lifestyles and Sleep EducationParticipants randomized to this arm will receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines. | Other | Healthy Lifestyles and Sleep Education |
Primary outcome
To compare the effects of nocturnal supplemental oxygen and PAP versus optimized medical management on biomarkers of cardiovascular risk, including:
Time frame: 3 months
* 24 hour blood pressure (BP) profile * Markers of systemic inflammation * Markers of oxidative stress * Prothrombotic markers * Sympathetic nervous system activity * Cardiac rhythm, impulse generation and ischemia * Dyslipidemia * Glucose regulation * Myocardial stress
2 secondary outcomes
Compare the effects of nocturnal supplemental oxygen and PAP versus standard care on patient-reported outcomes, including:
Time frame: 3 months
Compare nocturnal supplemental oxygen and PAP on measures of:
Time frame: 3 months
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 25 Feb 2013.
- Derived from this study: PubMed 41424523Hilmisson H, Thomas RJ, Magnusdottir S. Cardiopulmonary coupling-calculated sleep stability and nocturnal heart rate kinetics as a potential indicator for cardiovascular health: a relationship with blood pressure dipping. Front Sleep. 2024 Aug 1;3:1230958. doi: 10.3389/frsle.2024.1230958. eCollection 2024.
- Derived from this study: PubMed 38507976Ni YN, Lei F, Tang X, Liang Z, Thomas RJ. The association between the effective apnea-hypopnea index and blood pressure reduction efficacy following CPAP/oxygen treatment. Sleep Med. 2024 May;117:46-52. doi: 10.1016/j.sleep.2024.02.046. Epub 2024 Mar 13.
- Derived from this study: PubMed 37938917Schmickl CN, Orr JE, Sands SA, Alex RM, Azarbarzin A, McGinnis L, White S, Mazzotti DR, Nokes B, Owens RL, Gottlieb DJ, Malhotra A. Loop Gain as a Predictor of Blood Pressure Response in Patients Treated for Obstructive Sleep Apnea: Secondary Analysis of a Clinical Trial. Ann Am Thorac Soc. 2024 Feb;21(2):296-307. doi: 10.1513/AnnalsATS.202305-437OC.
- Derived from this study: PubMed 34225174Magnusdottir S, Thomas RJ, Hilmisson H. Can improvements in sleep quality positively affect serum adiponectin-levels in patients with obstructive sleep apnea? Sleep Med. 2021 Aug;84:324-333. doi: 10.1016/j.sleep.2021.05.032. Epub 2021 May 29.
- Derived from this study: PubMed 32649638Magnusdottir S, Hilmisson H, Thomas RJ. Cardiopulmonary coupling-derived sleep quality is associated with improvements in blood pressure in patients with obstructive sleep apnea at high-cardiovascular risk. J Hypertens. 2020 Nov;38(11):2287-2294. doi: 10.1097/HJH.0000000000002553.
- Derived from this study: PubMed 24918372Gottlieb DJ, Punjabi NM, Mehra R, Patel SR, Quan SF, Babineau DC, Tracy RP, Rueschman M, Blumenthal RS, Lewis EF, Bhatt DL, Redline S. CPAP versus oxygen in obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2276-85. doi: 10.1056/NEJMoa1306766.
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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.
Susan Redline, MD, MPH principal investigator
Brigham and Women's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Healthy Lifestyles and Sleep Education plus PAP, Healthy Lifestyles and Sleep Education plus Supplemental Oxygen and Healthy Lifestyles and Sleep Education in people with Cardiovascular Disease and Obstructive Sleep Apnea, run by Brigham and Women's Hospital at 4 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 2 inclusion and 2 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 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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?
To compare the effects of nocturnal supplemental oxygen and PAP versus optimized medical management on biomarkers of cardiovascular risk, including: (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01086800, which also lists 6 linked publications.
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 Feb 2013.