Cardiovascular Improvements With MV ASV Therapy in Heart Failure
NCT ID: NCT01953874
Last Updated: 2018-02-28
Study Results
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View full resultsBasic Information
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TERMINATED
NA
126 participants
INTERVENTIONAL
2013-12-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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MV ASV+OMT
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
MV ASV
Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment
Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
OMT only
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.
Optimized Medical Treatment
Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
Interventions
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MV ASV
Minute ventilation-targeted servo-ventilation therapy.
Optimized Medical Treatment
Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* Sustained systolic blood pressure \<80 mmHg at baseline
* Acute coronary syndrome within 1 months of randomization
* Active myocarditis
* Complex congenital heart disease
* Constrictive pericarditis
* 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
21 Years
ALL
No
Sponsors
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ResMed Foundation
OTHER
ResMed
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher O'Connor, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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The Heart Center
Huntsville, Alabama, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
VA Medical Center
Denver, Colorado, United States
Mercer University
Macon, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Maryland
Baltimore, Maryland, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Penn State Hershey
Hershey, Pennsylvania, United States
Jefferson Heart Institute
Philadelphia, Pennsylvania, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
University of Washington
Seattle, Washington, United States
Heart and Diabetes Center - North Rhine-Westphalia (HDZ-NRW)
Bad Oeynhausen, , Germany
Countries
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References
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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.
O'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.
Fiuzat 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.
Other Identifiers
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MA-12-12-01
Identifier Type: -
Identifier Source: org_study_id
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