Heart Failure With Normal Ejection FractionCAT-PEFNCT03195660
Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study
A study testing ASV Therapy in people with Heart Failure With Normal Ejection Fraction and Sleep Apnea, run by ResMed at 4 sites in 2 countries.
Trial summary
This study is designed to demonstrate feasibility of study conduct and that acceptable adherence to adaptive servo-ventilation (ASV) therapy can be achieved in recently hospitalized HFpEF patients with moderate to severe sleep apnea. All subjects meeting the criteria will receive ASV therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Normal Ejection Fraction, Sleep Apnea
- What is being tested?
- ASV Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 26 Jun 2017to 15 Nov 2017
- 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
- Patients 18 years or older
- Patients with heart failure with preserved ejection fraction (HFpEF; LVEF ≥50%)
- 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:
Show all 9Show fewer
- Orthopnea ii. Pulmonary rales that do not clear with cough iii. Congestion on chest X-ray iv. Local BNP or NT pro-BNP level: A. No current atrial fibrillation (AFib): BNP≥100 pg/mL or NT pro- BNP≥300 pg/mL OR B. Current AFib: BNP≥150 pg/mL or NT pro-BNP≥450 pg/mL
- Sleep disordered breathing (SDB) documented by screening polygraphy with an AHI≥15 events/hour (e/hr)
- 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 study entry) of any PAP therapy (eg, 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 13Show fewer
- Transient ischemic attack (TIA) or Stroke within 3 months prior to study entry
- Definite clinically evident acute myocardial infarction within 3 months of study entry
- Known amyloidosis, hypertrophic obstructive cardiomyopathy, or arteriovenous fistulas
- Moderate or greater valvular heart disease as the primary reason for heart failure
- Pregnant, or planning to become pregnant during the study period
- In the opinion of the investigator, the index acute decompensated HF event was 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 States3 sites
Inova Heart and Vascular Institute
Falls Church, Virginia, 22042
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of California San Diego
San Diego, California, 92123
Germany1 site
Heart and Diabetes Center - West Rhine-Westphalia
Bad Oeynhausen
About this study
This study is designed to demonstrate feasibility of study conduct and that acceptable adherence to adaptive servo-ventilation (ASV) therapy can be achieved in recently hospitalized HFpEF patients with moderate to severe sleep apnea. All subjects meeting the criteria will receive ASV therapy.
Read the detailed description
Cardiovascular Improvements with Minute Ventilation-targeted ASV Therapy in Heart Failure Study (CAT-HF) was a randomized controlled clinical trial in the United States and Germany. It was designed to evaluate the effect of ASV in hospitalized heart failure (HFrEF and HFpEF) patients on a global rank endpoint of survival free from CV hospitalization and improvement in functional capacity measured by 6-minute walk distance. Analysis of the 126 subjects that were randomized showed a neutral result for the primary endpoint; however, in the pre-specified analysis of the primary endpoint by LVEF strata, there was a favorable statistically significant difference in the HFpEF subgroup (p=0.036).
Although the CAT-HF study showed a positive signal in the HFpEF subgroup, these patients represented a small percentage of the randomized subjects in the study. The current study aims to show that by applying newer technologies to support adherence, as well as focusing on the lessons learned in CAT-HF to identify and recruit HFpEF patients, acceptable adherence to ASV therapy can be achieved in HFpEF patients.
- Being tested
- ASV Therapy
- Keywords
- adaptive servo-ventilation, ASV, HFpEF
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASV TherapyDevice
Also called AirCurve 10 ASV
AirCurve 10 ASV device set up in AutoSet mode
| Study group | Role | What they receive |
|---|---|---|
| ASV Therapy | Experimental | ASV Therapy Receives: Device: ASV Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASV Adherence
Average hours used per day
Measured: 3 months
Secondary outcomes (3)
KCCQ-12
Change in KCCQ-12 score. Cardiomyopathy Questionnaire (Kansas City) (KCCQ-12) is a short questionnaire to evaluate quality of life in heart failure patients. All scores are scaled from 0-100 where low scares represent very poor health and high scores represent excellent health.
Measured: 3 months
Hospitalizations
Number of hospitalizations per subject
Measured: 3 months
Death
Number of deaths
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 posted22 Jun 2017
- Study start26 Jun 2017
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
Why it stopped: Funding for study was withdrawn
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 Failure With Normal Ejection FractionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm, un-blinded, multi-center
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher O'Connor, MD, Study chair, Inova Heart and Vascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195660
- Sponsor's protocol ID
- MA-16-12-01
- Acronym
- CAT-PEF
- Status last verified
- Apr 2021
- First submitted
- 20 Jun 2017
- Last updated
- 14 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study
- ClinicalTrials.gov ID
- NCT03195660
- Acronym / sponsor ID
- CAT-PEF / MA-16-12-01
- Keywords
- adaptive servo-ventilation, ASV, HFpEF
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding for study was withdrawn
- Enrolment
- 6 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Posted 14 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to demonstrate feasibility of study conduct and that acceptable adherence to adaptive servo-ventilation (ASV) therapy can be achieved in recently hospitalized HFpEF patients with moderate to severe sleep apnea. All subjects meeting the criteria will receive ASV therapy.
Detailed description
Cardiovascular Improvements with Minute Ventilation-targeted ASV Therapy in Heart Failure Study (CAT-HF) was a randomized controlled clinical trial in the United States and Germany. It was designed to evaluate the effect of ASV in hospitalized heart failure (HFrEF and HFpEF) patients on a global rank endpoint of survival free from CV hospitalization and improvement in functional capacity measured by 6-minute walk distance. Analysis of the 126 subjects that were randomized showed a neutral result for the primary endpoint; however, in the pre-specified analysis of the primary endpoint by LVEF strata, there was a favorable statistically significant difference in the HFpEF subgroup (p=0.036).
Although the CAT-HF study showed a positive signal in the HFpEF subgroup, these patients represented a small percentage of the randomized subjects in the study. The current study aims to show that by applying newer technologies to support adherence, as well as focusing on the lessons learned in CAT-HF to identify and recruit HFpEF patients, acceptable adherence to ASV therapy can be achieved in HFpEF patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm, un-blinded, multi-center
| Arm | Type | Receives |
|---|---|---|
| ASV Therapy | Experimental | Device: ASV TherapyASV Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients 18 years or older
- Patients with heart failure with preserved ejection fraction (HFpEF; LVEF ≥50%)
- Hospital admission or equivalent (such as ER visit alone or clinic visit alone) and acute decompensated HF as determined by:
- Sleep disordered breathing (SDB) documented by screening polygraphy with an AHI≥15 events/hour (e/hr)
- Patient is able to fully understand study information and sign informed consent
Key exclusion criteria (13 listed)
- Right-sided heart failure without left-sided failure
- Current chronic use (within 4 weeks of study entry) of any PAP therapy (eg, 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 |
|---|---|---|
| ASV TherapyAlso: AirCurve 10 ASVAirCurve 10 ASV device set up in AutoSet mode | Device | ASV Therapy |
Primary outcome
ASV Adherence
Time frame: 3 months
Average hours used per day
3 secondary outcomes
KCCQ-12
Time frame: 3 months
Hospitalizations
Time frame: 3 months
Death
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 14 May 2021.
- 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.
Christopher O'Connor, MD study chair
Inova Heart and Vascular Institute
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASV Therapy in people with Heart Failure With Normal Ejection Fraction and Sleep Apnea, run by ResMed 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 9 inclusion and 13 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 14 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?
Yes. Results are posted in the registry (first posted 14 May 2021). 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?
ASV Adherence (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 14 May 2021.