ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01953874
Recruitment Status : Terminated (SERVE-HF results showed ASV increased CV mortality in patients with reduced LVEF)
First Posted : October 1, 2013
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
ResMed Foundation
Information provided by (Responsible Party):
ResMed

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 Phase
Acute Decompensated Heart Failure Sleep Disordered Breathing Device: MV ASV Drug: Optimized Medical Treatment Not Applicable

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 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
Actual Primary Completion Date : December 2015
Actual 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. 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.


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

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

  3. Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Change from Baseline to 6 months ]
    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.

  4. Biomarkers - Inflammation [ Time Frame: Change from Baseline to 6 months ]
    Biomarkers of inflammation reported as troponin I ultra-sensitive

  5. Biomarkers - Cardiovascular [ Time Frame: Change from Baseline to 6 months ]
    Biomarkers of cardiovascular function reported as hs-CRP

  6. Biomarkers - Renal Function [ Time Frame: Change from Baseline to 6 months ]
    Biomarkers of renal function reported as creatinine

  7. ECHO Parameters - LVEF [ Time Frame: Change from Baseline to 6 months ]
    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).

  8. ECHO Parameters - LVESVI [ Time Frame: Change from Baseline to 6 months ]
    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).

  9. ECHO Parameters - E/e' Ratio [ Time Frame: Change from Baseline to 6 months ]
    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).

  10. 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.

  11. Sleep Parameters [ Time Frame: Change from Baseline to 6 months ]
    Sleep and sleep disordered breathing parameters (AHI, nocturnal hypoxemia)

  12. Number of Subjects With 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

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

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

  15. DASI [ Time Frame: Change from Baseline to 6 months ]
    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.

  16. EQ-5D-5L Index [ Time Frame: Change from Baseline to 6 months ]
    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.

  17. PHQ-9 [ Time Frame: Change from Baseline to 6 months ]
    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.

  18. PSQI [ Time Frame: Change from Baseline to 6 months ]
    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.

  19. ESS [ Time Frame: Change from Baseline to 6 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


Locations
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
Saint 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
Germany
Heart and Diabetes Center - North Rhine-Westphalia (HDZ-NRW)
Bad Oeynhausen, Germany
Sponsors and Collaborators
ResMed
ResMed Foundation
Investigators
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
Results First Posted: February 28, 2018
Last Update Posted: February 28, 2018
Last Verified: January 2018

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