Sleep Disorder; Breathing-RelatedPEP-ASVNCT04133350
Patients With Heart Failure With Preserved Ejection Fraction Adherence to ASV Therapy (PEP ASV)
A study testing Active Patient Engagement in people with Sleep Disorder; Breathing-Related and Heart Failure, run by Thomas Jefferson University at 4 sites in 2 countries.
Trial summary
This is a prospective, single-arm, unblinded pilot study and registry that aims to demonstrate adherence to adaptive servo-ventilation (ASV) therapy in patients with moderate to severe sleep disordered breathing who have been recently hospitalized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorder; Breathing-Related, Heart Failure
- What is being tested?
- Active Patient Engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 16 Oct 2019to 1 Feb 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients 18 years or older 2. Patients with heart failure with preserved ejection fraction (HFpEF; LVEF ≥50%) 3. Hospital admission or equivalent (such as ER visit alone or clinic visit alone) and acute decompensated HF as determined by:
- Dyspnea at rest or with minimal exertion AND
- Treatment with at least one dose of IV diuretic or ultrafiltration AND
- At least two of the following signs and symptoms:
- Orthopnea ii. Pulmonary rales that do not clear with cough iii. Congestion on chest X-ray iv. Local BNP or NT pro-BNP level:
- No current AFib: BNP≥100 pg/mL or NT pro-BNP≥300 pg/mL OR
- Current AFib: BNP≥150 pg/mL or NT pro-BNP≥450 pg/mL 4. Sleep disordered breathing (SDB) documented by screening polygraphy with an AHI≥15 events/hour (e/hr) 5. Patient is able to fully understand study information and sign informed consent
Who cannot join
- Right-sided heart failure without left-sided failure
- Current chronic use (within 4 weeks of registry entry) of any PAP therapy (e.g., CPAP, APAP, or bi-level) or contraindicated for PAP therapy
- Sustained systolic blood pressure <80 mmHg at baseline
- Complex congenital heart disease
- Constrictive pericarditis
- Chronic hypoxemia as evidenced by sustained oxygen saturation ≤ 85% at rest during the day or at start of nocturnal oximetry recording or regular use of oxygen therapy (day or night)
Show all 12Show fewer
- Transient ischemic attack (TIA) or Stroke within 3 months prior to registry entry
- Definite clinically evident acute myocardial infarction within 3 months of registry entry
- Known amyloidosis, hypertrophic obstructive cardiomyopathy, or arteriovenous fistulas
- Moderate or greater valvular heart disease as the primary reason for heart failure
- In the opinion of the investigator, the index acute decompensated HF event was not due primarily to uncontrolled AFib with fast ventricular response rate
- Inability to comply with planned study procedures
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
INOVA (Inova Heart and Vascular Institute, Inova Fairfax Hospital)
Falls Church, Virginia, 22042
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Germany2 sites
Herz- und Diabeteszentrum, Nordrhein-Westfalen
Bad Oeynhausen, Ruhr-Universität Bochum
Ludgerus Clinic, Department of Cardiology, Clemens Hospital
Münster
About this study
Official title: Patients With Heart Failure With Preserved Ejection Fraction Adherence to ASV Therapy Pilot Registry (PEP ASV Pilot Registry)
This is a prospective, single-arm, unblinded pilot study and registry that aims to demonstrate adherence to adaptive servo-ventilation (ASV) therapy in patients with moderate to severe sleep disordered breathing who have been recently hospitalized. ASV therapy has been linked to improved outcomes in this population, but adherence to therapy is low. The AirCurve 10 ASV device that will be used for this study employs newer technologies, such as web-based monitoring and provides patients feedback, which may increase therapy adherence and therefore improve patient outcomes.
- Conditions
- Sleep Disorder; Breathing-Related, Heart Failure
- Being tested
- Active Patient Engagement
- Medical subject headings
- Sleep Wake Disorders, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Patient EngagementBehavioural
The APE intervention will be delivered through a patient-facing application and website called myAir, which provides patients with access to their own usage data, educational tips, and coaching.
| Study group | Role | What they receive |
|---|---|---|
| Active Patient Engagement | Experimental | All patients are enrolled into the Active Patient Engagement (APE) arm. This arm will receive the APE intervention. Receives: Behavioral: Active Patient Engagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence (hours/night)
Demonstrate acceptable adherence to ASV therapy can be achieved in patients with moderate to severe SDB in a recently hospitalized population of Heart Failure patients with preserved ejection fraction (HFpEF).
Measured: 3 months
Secondary outcomes (1)
Quality of Life Score -
Quality of life will be assessed using the KCCQ-12, a 12-item validated instrument that measures Quality of Life in heart failure patients on a scale of 0-100. Higher scores indicate higher Quality of Life
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 posted21 Oct 2019
- Study start16 Oct 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Why it stopped: Inability to Recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder; Breathing-RelatedStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Inova Fairfax Hospital, Heart and Diabetes Center North Rhine-Westphalia, CLEMENS HOSPITAL, Resmed Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133350
- Sponsor's protocol ID
- 19P.115
- Acronym
- PEP-ASV
- Status last verified
- May 2021
- First submitted
- 17 Oct 2019
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Heart Failure With Preserved Ejection Fraction Adherence to ASV Therapy Pilot Registry (PEP ASV Pilot Registry)
- ClinicalTrials.gov ID
- NCT04133350
- Acronym / sponsor ID
- PEP-ASV / 19P.115
- Conditions
- Sleep Disorder; Breathing-Related, Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to Recruit
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Inova Fairfax Hospital, Heart and Diabetes Center North Rhine-Westphalia, CLEMENS HOSPITAL, Resmed Inc
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 21 Oct 2019 (actual)
- 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 is a prospective, single-arm, unblinded pilot study and registry that aims to demonstrate adherence to adaptive servo-ventilation (ASV) therapy in patients with moderate to severe sleep disordered breathing who have been recently hospitalized. ASV therapy has been linked to improved outcomes in this population, but adherence to therapy is low. The AirCurve 10 ASV device that will be used for this study employs newer technologies, such as web-based monitoring and provides patients feedback, which may increase therapy adherence and therefore improve patient outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Patient Engagement | Experimental | Behavioral: Active Patient EngagementAll patients are enrolled into the Active Patient Engagement (APE) arm. This arm will receive the APE intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Patients 18 years or older 2. Patients with heart failure with preserved ejection fraction (HFpEF; LVEF ≥50%) 3. Hospital admission or equivalent (such as ER visit alone or clinic visit alone) and acute decompensated HF as determined by:
- No current AFib: BNP≥100 pg/mL or NT pro-BNP≥300 pg/mL OR
- Current AFib: BNP≥150 pg/mL or NT pro-BNP≥450 pg/mL 4. Sleep disordered breathing (SDB) documented by screening polygraphy with an AHI≥15 events/hour (e/hr) 5. Patient is able to fully understand study information and sign informed consent
Key exclusion criteria (12 listed)
- Right-sided heart failure without left-sided failure
- Current chronic use (within 4 weeks of registry entry) of any PAP therapy (e.g., CPAP, APAP, or bi-level) or contraindicated for PAP therapy
- Sustained systolic blood pressure <80 mmHg at baseline
- Complex congenital heart disease
- Constrictive pericarditis
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 |
|---|---|---|
| Active Patient EngagementThe APE intervention will be delivered through a patient-facing application and website called myAir, which provides patients with access to their own usage data, educational tips, and coaching. | Behavioural | Active Patient Engagement |
Primary outcome
Adherence (hours/night)
Time frame: 3 months
Demonstrate acceptable adherence to ASV therapy can be achieved in patients with moderate to severe SDB in a recently hospitalized population of Heart Failure patients with preserved ejection fraction (HFpEF).
1 secondary outcome
Quality of Life Score -
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Inability to Recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Patient Engagement in people with Sleep Disorder; Breathing-Related and Heart Failure, run by Thomas Jefferson University at 4 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 27 May 2021. 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, 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. 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 stopped early (reason given: Inability to Recruit). Results are not available in the source record.
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?
Adherence (hours/night) (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 27 May 2021.