Sleep Apnea, ObstructiveASAP-HFNCT02963597
Auto-PAP for Pulmonary Hypertension Treatment in Decompensated HF Patients With Sleep Apnea.
A study testing AirSense™ 10 AutoSet and Standard Medical Therapy in people with Sleep Apnea, Obstructive and Hypertension, Pulmonary, run by Albert Einstein Healthcare Network at 2 sites in 2 countries.
Trial summary
The objective of the study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Hypertension, Pulmonary, Heart Failure
- What is being tested?
- AirSense™ 10 AutoSet and Standard Medical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2016to 15 Aug 2018
- 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
- Age 18 years or more
- Decompensated Congestive Heart Failure with systolic Pulmonary Artery pressures of ≥50 mmHg (including Right Atrial pressure)
- Prior clinical diagnosis of heart failure
- Moderate to Severe predominately obstructive sleep disordered breathing documented by polygraphy with Apnea Hypopnea Index (AHI) ≥20e/h and 5% of the time spent <90% O2 Sat (minimum 2hr recording time)
- Patient is able to fully understand study information and sign informed consent
Who cannot join
- Chronic renal insufficiency (Hemodialysis or serum creatinine > 2)
- Hemodynamically significant valvular disease
- Severe arthritis or inability to complete 6 Minute Walk Test
- Left Ventricular Assist Device/ heart transplant or hemodynamically unstable
- Patient taking any Pulmonary vasodilators, including home oxygen.
- Known diagnosis of Obstructive Sleep Apnea (OSA) and on active therapy
Show all 10Show fewer
- 80% of the respiratory events being central/Cheyne-Stokes breathing
- Recent cardiac surgery (within 30 days of admission)
- Recent stroke (within 30 days of admission or with persistent neurological deficits)
- Severe Chronic Obstructive Pulmonary Disease defined as forced expiratory volume at one second (FEV1) < 50%
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
Germany1 site
Heart and Diabetes Center NRW
Bad Oeynhausen, North Rhine-Westphalia, 32545
About this study
Official title: Auto-PAP for Pulmonary Hypertension Treatment in Decompensated Heart Failure Patients With Obstructive Sleep Apnea: A Two Center Pilot Study
The objective of the study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters.
Read the detailed description
The ASAP-HF study is a prospective, randomized, controlled, two-center, study with a parallel group design, with subjects randomized to either control (no APAP) or active treatment (APAP) in a 1:1 ratio. Group A (active): standard medical therapy plus treatment with continuous APAP for 48hrs, or Group B (control): standard medical therapy only.
Many people who have heart failure (HF) also have sleep-disordered breathing (SDB), which is breathing irregularities during sleep. These irregularities may interrupt the sleep as well as increase the rate of progression of Heart Failure. The ASAP-HF study is being done to see if certain clinical outcomes are improved in acute decompensated heart failure (HF) patients with SDB by using a non-invasive breathing device continuously for a short period of time (48 hours) while patient is still in the hospital. The device is called AirSense™ 10 AutoSet (AutoSet). It consists of an air flow generator, air tubing, an air humidifier, and a mask. As the patient breathe through the mask, the AutoSet monitors breathing.
The primary objective of this pilot study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters . This device is not currently used to diagnose sleep apnea and its utility is not well studied. This study will establish the utility of the device in diagnosing sleep apnea.
- Being tested
- AirSense™ 10 AutoSet, Standard Medical Therapy
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension, Pulmonary, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirSense™ 10 AutoSetDevice
The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.
Standard Medical TherapyOther
Standard medical therapy according to current guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. Receives: Device: AirSense™ 10 AutoSet; Other: Standard Medical Therapy |
| Group B | Placebo comparator | Standard medical therapy only. Receives: Other: Standard Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Artery Systolic Pressure.
The primary objective of this pilot study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with severe obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters.
Measured: 48 hours
Secondary outcomes (7)
Functional Parameters (6 Minute Walk Test) From Baseline to 48hrs
6-minute walk tests were performed on admission and repeated after 48 hours from the initial. The walked distance was measured in meters.
Measured: 48 hours
N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline to 48hrs
To compare changes in N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) measured at baseline and compared to 48hrs after.
Measured: 48 hours
Length of Stay
The total stay in the hospital during the admission will be measured by days.
Measured: 1 year
Blood Oxygenation.
Changes in arterial blood oxygenation will be compared via arterial blood gas analysis performed at baseline and after 48h to assess arterial pressure of oxygen.
Measured: 48 hours
Heart Failure Symptoms
Heart failure symptoms as assessed by the New York Heart Association scale (NYHA) classification at baseline and after 48 hours. NYHA scale ranges from Class I to IV. Higher classes are associated with worst outcomes.
Class I: No symptoms and no limitation in ordinary physical activity. Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity.Comfortable only at rest.
Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Measured: 48 hours
Fluid Retention
Change in fluid retention as measured by weight at baseline and after 48 hours.
Measured: 48 hours
E/e' as an Assumption of LVEDP.
Measurement of E/e' in 2D echocardiography as an assumption of LVEDP and PV acceleration time comparing baseline and after 48hrs.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start1 Oct 2016
- Primary completionAug 2017
- Study completion15 Aug 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CPAP Device
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Collaborators
- Resmed Inc
- Responsible party
- Sponsor
- Investigators
- Sunil Sharma, MD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963597
- Sponsor's protocol ID
- 4889
- Acronym
- ASAP-HF
- Status last verified
- Mar 2019
- First submitted
- 10 Nov 2016
- Last updated
- 30 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sharma S, Fox H, Aguilar F, Mukhtar U, Willes L, Bozorgnia B, Bitter T, Oldenburg O. Auto positive airway pressure therapy reduces pulmonary pressures in adults admitted for acute heart failure with pulmonary hypertension and obstructive sleep apnea. The ASAP-HF Pilot Trial. Sleep. 2019 Jul 8;42(7):zsz100. doi: 10.1093/sleep/zsz100.
PubMed 31004141
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auto-PAP for Pulmonary Hypertension Treatment in Decompensated Heart Failure Patients With Obstructive Sleep Apnea: A Two Center Pilot Study
- ClinicalTrials.gov ID
- NCT02963597
- Acronym / sponsor ID
- ASAP-HF / 4889
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Collaborators
- Resmed Inc
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Posted 30 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters.
Detailed description
The ASAP-HF study is a prospective, randomized, controlled, two-center, study with a parallel group design, with subjects randomized to either control (no APAP) or active treatment (APAP) in a 1:1 ratio. Group A (active): standard medical therapy plus treatment with continuous APAP for 48hrs, or Group B (control): standard medical therapy only.
Many people who have heart failure (HF) also have sleep-disordered breathing (SDB), which is breathing irregularities during sleep. These irregularities may interrupt the sleep as well as increase the rate of progression of Heart Failure. The ASAP-HF study is being done to see if certain clinical outcomes are improved in acute decompensated heart failure (HF) patients with SDB by using a non-invasive breathing device continuously for a short period of time (48 hours) while patient is still in the hospital. The device is called AirSense™ 10 AutoSet (AutoSet). It consists of an air flow generator, air tubing, an air humidifier, and a mask. As the patient breathe through the mask, the AutoSet monitors breathing.
The primary objective of this pilot study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters . This device is not currently used to diagnose sleep apnea and its utility is not well studied. This study will establish the utility of the device in diagnosing sleep apnea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- CPAP Device
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: AirSense™ 10 AutoSet, Other: Standard Medical TherapyStandard medical therapy plus AirSense™ 10 AutoSet for 48hrs. |
| Group B | Placebo comparator | Other: Standard Medical TherapyStandard medical therapy only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or more
- Decompensated Congestive Heart Failure with systolic Pulmonary Artery pressures of ≥50 mmHg (including Right Atrial pressure)
- Prior clinical diagnosis of heart failure
- Moderate to Severe predominately obstructive sleep disordered breathing documented by polygraphy with Apnea Hypopnea Index (AHI) ≥20e/h and 5% of the time spent <90% O2 Sat (minimum 2hr recording time)
- Patient is able to fully understand study information and sign informed consent
Key exclusion criteria (10 listed)
- Chronic renal insufficiency (Hemodialysis or serum creatinine > 2)
- Hemodynamically significant valvular disease
- Severe arthritis or inability to complete 6 Minute Walk Test
- Left Ventricular Assist Device/ heart transplant or hemodynamically unstable
- Patient taking any Pulmonary vasodilators, including home oxygen.
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 |
|---|---|---|
| AirSense™ 10 AutoSetThe AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water. | Device | Group A |
| Standard Medical TherapyStandard medical therapy according to current guidelines. | Other | Group A, Group B |
Primary outcome
Pulmonary Artery Systolic Pressure.
Time frame: 48 hours
The primary objective of this pilot study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with severe obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters.
7 secondary outcomes
Functional Parameters (6 Minute Walk Test) From Baseline to 48hrs
Time frame: 48 hours
N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline to 48hrs
Time frame: 48 hours
Length of Stay
Time frame: 1 year
Blood Oxygenation.
Time frame: 48 hours
Heart Failure Symptoms
Time frame: 48 hours
Fluid Retention
Time frame: 48 hours
E/e' as an Assumption of LVEDP.
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31004141Sharma S, Fox H, Aguilar F, Mukhtar U, Willes L, Bozorgnia B, Bitter T, Oldenburg O. Auto positive airway pressure therapy reduces pulmonary pressures in adults admitted for acute heart failure with pulmonary hypertension and obstructive sleep apnea. The ASAP-HF Pilot Trial. Sleep. 2019 Jul 8;42(7):zsz100. doi: 10.1093/sleep/zsz100.
- 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.
Sunil Sharma, MD principal investigator
Albert Einstein Healthcare Network
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AirSense™ 10 AutoSet and Standard Medical Therapy in people with Sleep Apnea, Obstructive and Hypertension, Pulmonary, run by Albert Einstein Healthcare Network at 2 sites in 2 countries.
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 5 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 30 Mar 2020. 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, Germany. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2020). 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?
Pulmonary Artery Systolic Pressure. (time frame: 48 hours). 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 NCT02963597, which also lists 1 linked publication.
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 30 Mar 2020.