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Cardiovascular Improvements With MV ASV Therapy in Heart Failure (CAT-HF)

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ClinicalTrials.gov Identifier: NCT01953874
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : January 5, 2016
ResMed Foundation
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment
Acute Decompensated Heart Failure Sleep Disordered Breathing Device: MV ASV Drug: Optimized Medical Treatment

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Cardiovascular Improvements With Minute Ventilation-targeted ASV Therapy in Heart Failure (CAT-HF)
Study Start Date : December 2013
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: MV ASV+OMT
Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment
Device: MV ASV
Minute ventilation-targeted servo-ventilation therapy.
Other Names:
  • VPAP Adapt
  • AutoSet CS
Drug: 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
Active Comparator: 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.
Drug: 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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Six-minute Walk Distance [ Time Frame: Baseline, 6 months ]
    Change in functional parameters as measured by 6-minute walk test (6MWT)

  2. NT pro-BNP [ Time Frame: Baseline, 1 month, 6 months ]
    Change in neurohumoral activation as measured by N-terminal pro b-type natriuretic peptide

  3. KCCQ [ Time Frame: Baseline, 3 months, 6 months ]
    Patient-reported outcome of disease specific quality of life

  4. Biomarkers [ Time Frame: Baseline, 1 month, 6 months ]
    Biomarkers of inflammation, cardiovascular and renal function (troponin I ultra-sensitive, hs-CRP, creatinine)

  5. ECHO parameters [ Time Frame: Baseline, 6 months ]
    Echocardiographic parameters, including LVEF and LVESVI for patients with HFrEF, and E/e' for patients with HFpEF

  6. Win Ratio [ Time Frame: 6 months ]
    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.

  7. Sleep parameters [ Time Frame: 1 week, 1, 3, and 6 months ]
    Sleep and sleep disordered breathing parameters (AHI, nocturnal hypoxemia, CSR cycle length)

  8. HF Hospitalization [ Time Frame: 2 days, 1 week, 1, 2, 3, and 6 months ]
    Rates of hospitalization or urgent clinic visit for worsening of heart failure and for any reason

  9. Death [ Time Frame: 2 days, 1 week, 1, 2, 3, and 6 months ]
    Rate of Cardiovascular and all-cause death

  10. Time dead/hospitalized [ Time Frame: 6 months ]
    Total days dead or hospitalized at study end

  11. DASI [ Time Frame: Baseline, 6 months ]
    Patient-reported outcome of disease specific quality of life

  12. EQ-5D-5L [ Time Frame: Baseline, 6 months ]
    Standardized self-report questionnaire that is used as a measure of general health outcome

  13. PHQ-9 [ Time Frame: Baseline, 6 months ]
    Self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression

  14. PSQI [ Time Frame: Baseline, 3 months, 6 months ]
    A subjective measurement of the quality and patterns of sleep in the older adult

  15. ESS [ Time Frame: Baseline, 3 months, 6 months ]
    A self-administered questionnaire which provides a measurement of the general level of daytime sleepiness

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
    • 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:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953874

United States, Alabama
The Heart Center
Huntsville, Alabama, United States, 35801
United States, California
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
United States, Colorado
VA Medical Center
Denver, Colorado, United States, 80220
United States, Georgia
Mercer University
Macon, Georgia, United States, 31201
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Missouri
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Penn State Hershey
Hershey, Pennsylvania, United States, 17033
Jefferson Heart Institute
Philadelphia, Pennsylvania, United States, 19107
United States, Virginia
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States, 23507
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Heart and Diabetes Center - North Rhine-Westphalia (HDZ-NRW)
Bad Oeynhausen, Germany
Sponsors and Collaborators
ResMed Foundation
Principal Investigator: Christopher O'Connor, MD Duke University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01953874     History of Changes
Other Study ID Numbers: MA-12-12-01
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016

Keywords provided by ResMed:
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

Additional relevant MeSH terms:
Heart Failure
Respiratory Aspiration
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes