Acute Decompensated Heart FailureCAT-HFNCT01953874
Cardiovascular Improvements With MV ASV Therapy in Heart Failure
A study testing MV ASV and Optimized Medical Treatment in people with Acute Decompensated Heart Failure and Sleep Disordered Breathing, run by ResMed at 15 sites in 2 countries.
Trial summary
The aim of the study is to compare the effects of MV targeted ASV in addition to optimized medical therapy versus optimized medical therapy alone at 6 months in patients with acute decompensated HF. The study will also assess changes in functional parameters, biomarkers, quality of life (QOL), and sleep. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure, Sleep Disordered Breathing
- What is being tested?
- MV ASV and Optimized Medical Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Dec 2013to Dec 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 21 years or older
- Patients with prior clinical diagnosis of heart failure (HFrEF or HFpEF), or de novo diagnosis of HFpEF indicated by a local BNP≥300 pg/mL or NT pro-BNP≥1200 pg/mL on admission without systolic blood pressure >180 mmHg or atrial fibrillation, or diagnosis of HFrEF indicated by documented evidence of prescribed beta-blockers and ACE-inhibitors or ARBs for at least 4 weeks prior to admission
- Hospital admission for acute decompensated HF as determined by:
- Dyspnea at rest or with minimal exertion
- AND At least two of the following signs and symptoms:
- Orthopnea
Show all 14Show fewer
- Pulmonary rales beyond basilar
- Chest congestion on x-ray
- BNP≥300pg/mL or NT pro-BNP≥1200pg/mL
- Pulmonary capillary wedge pressure (PCWP) ≥25mmHg during current hospitalization
- Presented to hospital or clinic at least 24 hours prior to consent
- Patient stable enough to stop oxygen use for duration of polygraphy test or have access to dual lumen cannula for polygraphy test
- Sleep disordered breathing (SDB) documented by polygraphy with an AHI≥15 events/hour
- Patient is able to fully understand study information and sign a consent form
Who cannot join
- Right-sided heart failure without left-sided heart failure
- Sustained systolic blood pressure <80 mmHg at baseline
- Acute coronary syndrome within 1 months of randomization
- Active myocarditis
- Complex congenital heart disease
- Constrictive pericarditis
Show all 29Show fewer
- Non-cardiac pulmonary edema
- Clinical evidence of digoxin toxicity
- Need for mechanical hemodynamic support at time of randomization
- Oxygen saturation ≤85% at rest during the day or at start of nocturnal oximetry recording or regular use of oxygen therapy (day or night)
- COPD exacerbation as the primary reason for hospital admission
- Current use (within 4 weeks of study entry) of any PAP-therapy (eg, fixed, bi-level, or APAP)
- Life expectancy < 1 year for diseases unrelated to HF
- Transient ischemic attack (TIA) or Stroke within 3 months prior to randomization
- CABG procedure within 3 months prior to randomization, or planned to occur during study period
- CRT implant within 3 months prior to randomization , or planned to occur during study period
- VAD implant planned to occur during study period
- Heart transplant list Status 1a or 1b
- Status post-transplant or LVAD
- Prescribed inotrope therapy anticipated at discharge
- Chronic Dialysis
- Known amyloidosis, hypertrophic obstructive cardiomyopathy, arteriovenous fistulas
- Primary hemodynamically significant uncorrected valvular heart disease (obstructive or regurgitant) with planned intervention within 6 months of randomization
- Pregnant, or planning to become pregnant
- Cannot tolerate ASV treatment during run-in
- Cannot perform 6MWT at baseline
- Occupation as a commercial driver or pilot and plan to be performing these activities during the study period
- Inability to comply with planned study procedures
- Participation in pharmaceutical or treatment-related clinical study within 1 month of study enrollment
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
University of Maryland
Baltimore, Maryland, 21201
Northwestern University
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio, 45267
VA Medical Center
Denver, Colorado, 80220
Duke University Medical Center
Durham, North Carolina, 27710
Penn State Hershey
Hershey, Pennsylvania, 17033
The Heart Center
Huntsville, Alabama, 35801
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Mercer University
Macon, Georgia, 31201
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
Jefferson Heart Institute
Philadelphia, Pennsylvania, 19107
University of Washington
Seattle, Washington, 98195
Washington University School of Medicine
St Louis, Missouri, 63110
Germany1 site
Heart and Diabetes Center - North Rhine-Westphalia (HDZ-NRW)
Bad Oeynhausen
About this study
Official title: Cardiovascular Improvements With Minute Ventilation-targeted ASV Therapy in Heart Failure (CAT-HF)
The aim of the study is to compare the effects of MV targeted ASV in addition to optimized medical therapy versus optimized medical therapy alone at 6 months in patients with acute decompensated HF. The study will also assess changes in functional parameters, biomarkers, quality of life (QOL), and sleep.
Read the detailed description
This study is a randomized, unblinded, multi-center trial with parallel group design, with subjects randomized to either control (optimized medical therapy for chronic heart failure) or active treatment (optimized medical therapy plus use of MV-targeted ASV) in a 1:1 ratio.
- Being tested
- MV ASV, Optimized Medical Treatment
- Keywords
- heart failure, congestive heart failure, acute decompensated heart failure, chronic heart failure, left-sided heart failure, heart failure decompensation, sleep apnea, sleep disordered breathing, central sleep apnea, obstructive sleep apnea, cheyne-stokes respiration
- Medical subject headings
- Sleep Apnea Syndromes, Heart Failure, Sleep Apnea, Central, Sleep Apnea, Obstructive, Cheyne-Stokes Respiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MV ASVDevice
Also called VPAP Adapt, AutoSet CS
Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical TreatmentDrug
Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
| Study group | Role | What they receive |
|---|---|---|
| MV ASV+OMT | Experimental | Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment Receives: Device: MV ASV; Drug: Optimized Medical Treatment |
| OMT only | Active comparator | Optimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines. Receives: Drug: Optimized Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Rank Endpoint
A rank order response based on survival free from CV hospitalization and improvement in functional capacity measured by 6MWD. All participants were first ranked by time to death, then ranked by time to CV hospitalization, and then ranked by percentage change in 6MWD. For time to event measures (time to death and time to hospitalization), the shorter the amount of time, the lower the rank assigned to that participant. For percentage changes in 6MWD, the smaller the percentage change, the lower the rank assigned to that participant. Each component was then combined to create a rank value that ranged between 0 and 100. Overall, higher rank values are associated with better outcomes.
Measured: Baseline, 6 months
Secondary outcomes (19)
Six-minute Walk Distance
Change in functional parameters as measured by 6-minute walk test (6MWT)
Measured: Change from Baseline to 6 months
NT Pro-BNP
Change in neurohumoral activation as measured by N-terminal pro b-type natriuretic peptide.
Measured: Change from Baseline to 6 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)
The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: Change from Baseline to 6 months
Biomarkers - Inflammation
Biomarkers of inflammation reported as troponin I ultra-sensitive
Measured: Change from Baseline to 6 months
Biomarkers - Cardiovascular
Biomarkers of cardiovascular function reported as hs-CRP
Measured: Change from Baseline to 6 months
Biomarkers - Renal Function
Biomarkers of renal function reported as creatinine
Measured: Change from Baseline to 6 months
ECHO Parameters - LVEF
Echocardiographic parameters, including LVEF (left ventricular ejection fraction) and LVESVI (left ventricular end-systolic volume index) for patients with HFrEF (heart failure with reduced ejection fraction), and E/e' (ratio between early mitral inflow velocity and mitral annular early diastolic velocity) for patients with HFrEF or HFpEF (heart failure with preserved ejection fraction).
Measured: Change from Baseline to 6 months
ECHO Parameters - LVESVI
Echocardiographic parameters, including LVEF (left ventricular ejection fraction) and LVESVI (left ventricular end-systolic volume index) for patients with HFrEF (heart failure with reduced ejection fraction), and E/e' (ratio between early mitral inflow velocity and mitral annular early diastolic velocity) for patients with HFrEF or HFpEF (heart failure with preserved ejection fraction).
Measured: Change from Baseline to 6 months
ECHO Parameters - E/e' Ratio
Echocardiographic parameters, including LVEF (left ventricular ejection fraction) and LVESVI (left ventricular end-systolic volume index) for patients with HFrEF (heart failure with reduced ejection fraction), and E/e' (ratio between early mitral inflow velocity and mitral annular early diastolic velocity) for patients with HFpEF (heart failure with preserved ejection fraction).
Measured: Change from Baseline to 6 months
Win Ratio
Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labeled a 'winner' or a 'loser' depending on who had a CV death first. If that is not known, they are labeled a 'winner' or 'loser' depending on who had a HF hospitalization first. Otherwise they are considered tied. The win ratio is the total number of winners divided by the total numbers of losers.
Measured: 6 months
Sleep Parameters
Sleep and sleep disordered breathing parameters (AHI, nocturnal hypoxemia)
Measured: Change from Baseline to 6 months
Number of Subjects With HF Hospitalization
Rates of hospitalization or urgent clinic visit for worsening of heart failure and for any reason
Measured: 2 days, 1 week, 1, 2, 3, and 6 months
Death
Rate of Cardiovascular and all-cause death
Measured: 2 days, 1 week, 1, 2, 3, and 6 months
Time Dead/Hospitalized
Total days dead or hospitalized at study end
Measured: 6 months
DASI
The Duke Activity Status Index is a 12-item patient-reported outcome validated for the assessment of functional capacity based on the ability to perform everyday activities. With a total range of 0 to 58.20, a higher score indicates better quality of life.
Measured: Change from Baseline to 6 months
EQ-5D-5L Index
The EQ-5D-5L is a standardized self-report questionnaire that is used as a measure of health outcome. The EQ-5D-5L questionnaire is comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses were indexed using the EQ-5D-5L US value set to scale the 5 dimensions. A score of -0.109 indicates extreme problems for all dimensions and a score of 1.000 indicates no problems for all dimensions. Therefore, a higher score indicates better general health.
Measured: Change from Baseline to 6 months
PHQ-9
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The tool rates the frequency of the symptoms which factors into the following scoring severity index: 0 - Not at all, 1 - Several Days, 2 - More than Half the Days, 3 - Nearly Every Day. Total score can range from 0 to 27. A higher score indicates increased severity.
Measured: Change from Baseline to 6 months
PSQI
The Pittsburgh Sleep Quality Index is a 19-item subjective measurement of sleep. It is an effective instrument used to measure the quality and patterns of sleep in the older adult. It differentiates "poor" from "good" sleep by measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction over the last month. The subject self-rates each of these seven areas of sleep. The seven component scores are then added to yield a total score with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
Measured: Change from Baseline to 6 months
ESS
The Epworth Sleepiness Scale is a simple, 8-item self-administered questionnaire which provides a measurement of the subject's general level of daytime sleepiness. The individual is asked on a scale of 0-3 to score the likelihood of falling asleep in eight various situations. With a total range of 0 to 24, a higher score indicates increased severity.
Measured: Change from Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: SERVE-HF results showed ASV increased CV mortality in patients with reduced LVEF
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 (3)Papers the sponsor has linked to this study.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by ResMedThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ResMed Foundation
- Responsible party
- Sponsor
- Investigators
- Christopher O'Connor, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953874
- Sponsor's protocol ID
- MA-12-12-01
- Acronym
- CAT-HF
- Status last verified
- Jan 2018
- First submitted
- 23 Sep 2013
- Last updated
- 28 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Piccini JP, Pokorney SD, Anstrom KJ, Oldenburg O, Punjabi NM, Fiuzat M, Tasissa G, Whellan DJ, Lindenfeld J, Benjafield A, Woehrle H, Blase A, O'Connor CM. Adaptive servo-ventilation reduces atrial fibrillation burden in patients with heart failure and sleep apnea. Heart Rhythm. 2019 Jan;16(1):91-97. doi: 10.1016/j.hrthm.2018.07.027. Epub 2018 Jul 27.
PubMed 30059750O'Connor CM, Whellan DJ, Fiuzat M, Punjabi NM, Tasissa G, Anstrom KJ, Benjafield AV, Woehrle H, Blase AB, Lindenfeld J, Oldenburg O. Cardiovascular Outcomes With Minute Ventilation-Targeted Adaptive Servo-Ventilation Therapy in Heart Failure: The CAT-HF Trial. J Am Coll Cardiol. 2017 Mar 28;69(12):1577-1587. doi: 10.1016/j.jacc.2017.01.041.
PubMed 28335841Fiuzat M, Oldenberg O, Whellan DJ, Woehrle H, Punjabi NM, Anstrom KJ, Blase AB, Benjafield AV, Lindenfeld J, O'Connor CM. Lessons learned from a clinical trial: Design, rationale, and insights from The Cardiovascular Improvements with Minute Ventilation-targeted Adaptive Sero-Ventilation (ASV) Therapy in Heart Failure (CAT-HF) Study. Contemp Clin Trials. 2016 Mar;47:158-64. doi: 10.1016/j.cct.2016.01.001. Epub 2016 Jan 19.
PubMed 26806668
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Improvements With Minute Ventilation-targeted ASV Therapy in Heart Failure (CAT-HF)
- ClinicalTrials.gov ID
- NCT01953874
- Acronym / sponsor ID
- CAT-HF / MA-12-12-01
- Keywords
- heart failure, congestive heart failure, acute decompensated heart failure, chronic heart failure, left-sided heart failure, heart failure decompensation, sleep apnea, sleep disordered breathing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: SERVE-HF results showed ASV increased CV mortality in patients with reduced LVEF
- Enrolment
- 126 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Collaborators
- ResMed Foundation
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Posted 28 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare the effects of MV targeted ASV in addition to optimized medical therapy versus optimized medical therapy alone at 6 months in patients with acute decompensated HF. The study will also assess changes in functional parameters, biomarkers, quality of life (QOL), and sleep.
Detailed description
This study is a randomized, unblinded, multi-center trial with parallel group design, with subjects randomized to either control (optimized medical therapy for chronic heart failure) or active treatment (optimized medical therapy plus use of MV-targeted ASV) in a 1:1 ratio.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MV ASV+OMT | Experimental | Device: MV ASV, Drug: Optimized Medical TreatmentMinute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment |
| OMT only | Active comparator | Drug: Optimized Medical TreatmentOptimized Medical Treatment for heart failure in accordance with applicable guidelines (ACCF/AHA Guideline for the Management of Heart Failure and HFSA Heart Failure Guidelines. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients 21 years or older
- Patients with prior clinical diagnosis of heart failure (HFrEF or HFpEF), or de novo diagnosis of HFpEF indicated by a local BNP≥300 pg/mL or NT pro-BNP≥1200 pg/mL on admission without systolic blood pressure >180 mmHg or atrial fibrillation, or diagnosis of HFrEF indicated by documented evidence of prescribed beta-blockers and ACE-inhibitors or ARBs for at least 4 weeks prior to admission
- Hospital admission for acute decompensated HF as determined by:
- Presented to hospital or clinic at least 24 hours prior to consent
- Patient stable enough to stop oxygen use for duration of polygraphy test or have access to dual lumen cannula for polygraphy test
Key exclusion criteria (29 listed)
- Right-sided heart failure without left-sided heart failure
- Sustained systolic blood pressure <80 mmHg at baseline
- Acute coronary syndrome within 1 months of randomization
- Active myocarditis
- Complex congenital heart disease
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 |
|---|---|---|
| MV ASVAlso: VPAP Adapt, AutoSet CSMinute ventilation-targeted servo-ventilation therapy. | Device | MV ASV+OMT |
| Optimized Medical TreatmentBeta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated | Drug | MV ASV+OMT, OMT only |
Primary outcome
Global Rank Endpoint
Time frame: Baseline, 6 months
A rank order response based on survival free from CV hospitalization and improvement in functional capacity measured by 6MWD. All participants were first ranked by time to death, then ranked by time to CV hospitalization, and then ranked by percentage change in 6MWD. For time to event measures (time to death and time to hospitalization), the shorter the amount of time, the lower the rank assigned to that participant. For percentage changes in 6MWD, the smaller the percentage change, the lower the rank assigned to that participant. Each component was then combined to create a rank value that ranged between 0 and 100. Overall, higher rank values are associated with better outcomes.
19 secondary outcomes
Six-minute Walk Distance
Time frame: Change from Baseline to 6 months
NT Pro-BNP
Time frame: Change from Baseline to 6 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Change from Baseline to 6 months
Biomarkers - Inflammation
Time frame: Change from Baseline to 6 months
Biomarkers - Cardiovascular
Time frame: Change from Baseline to 6 months
Biomarkers - Renal Function
Time frame: Change from Baseline to 6 months
ECHO Parameters - LVEF
Time frame: Change from Baseline to 6 months
ECHO Parameters - LVESVI
Time frame: Change from Baseline to 6 months
ECHO Parameters - E/e' Ratio
Time frame: Change from Baseline to 6 months
Win Ratio
Time frame: 6 months
Sleep Parameters
Time frame: Change from Baseline to 6 months
Number of Subjects With HF Hospitalization
Time frame: 2 days, 1 week, 1, 2, 3, and 6 months
Death
Time frame: 2 days, 1 week, 1, 2, 3, and 6 months
Time Dead/Hospitalized
Time frame: 6 months
DASI
Time frame: Change from Baseline to 6 months
EQ-5D-5L Index
Time frame: Change from Baseline to 6 months
PHQ-9
Time frame: Change from Baseline to 6 months
PSQI
Time frame: Change from Baseline to 6 months
ESS
Time frame: Change from Baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30059750Piccini JP, Pokorney SD, Anstrom KJ, Oldenburg O, Punjabi NM, Fiuzat M, Tasissa G, Whellan DJ, Lindenfeld J, Benjafield A, Woehrle H, Blase A, O'Connor CM. Adaptive servo-ventilation reduces atrial fibrillation burden in patients with heart failure and sleep apnea. Heart Rhythm. 2019 Jan;16(1):91-97. doi: 10.1016/j.hrthm.2018.07.027. Epub 2018 Jul 27.
- Derived from this study: PubMed 28335841O'Connor CM, Whellan DJ, Fiuzat M, Punjabi NM, Tasissa G, Anstrom KJ, Benjafield AV, Woehrle H, Blase AB, Lindenfeld J, Oldenburg O. Cardiovascular Outcomes With Minute Ventilation-Targeted Adaptive Servo-Ventilation Therapy in Heart Failure: The CAT-HF Trial. J Am Coll Cardiol. 2017 Mar 28;69(12):1577-1587. doi: 10.1016/j.jacc.2017.01.041.
- Derived from this study: PubMed 26806668Fiuzat M, Oldenberg O, Whellan DJ, Woehrle H, Punjabi NM, Anstrom KJ, Blase AB, Benjafield AV, Lindenfeld J, O'Connor CM. Lessons learned from a clinical trial: Design, rationale, and insights from The Cardiovascular Improvements with Minute Ventilation-targeted Adaptive Sero-Ventilation (ASV) Therapy in Heart Failure (CAT-HF) Study. Contemp Clin Trials. 2016 Mar;47:158-64. doi: 10.1016/j.cct.2016.01.001. Epub 2016 Jan 19.
Related trials for Acute Decompensated Heart Failure
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
Acute Decompensated Heart Failure (ADHF)
Recruiting
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
Recruiting
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Acute Decompensated Heart Failure
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 principal investigator
Duke University
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MV ASV and Optimized Medical Treatment in people with Acute Decompensated Heart Failure and Sleep Disordered Breathing, run by ResMed at 15 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 14 inclusion and 29 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 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 28 Feb 2018). 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?
Global Rank Endpoint (time frame: Baseline, 6 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 NCT01953874, which also lists 3 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 28 Feb 2018.