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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by ResMed
Sponsor:
Collaborator:
ResMed Foundation
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT01953874
First received: September 23, 2013
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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 Intervention
Acute Decompensated Heart Failure
Sleep Disordered Breathing
Device: MV ASV
Drug: Optimized Medical Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Cardiovascular Improvements With Minute Ventilation-targeted ASV Therapy in Heart Failure (CAT-HF)

Resource links provided by NLM:


Further study details as provided by ResMed:

Primary Outcome Measures:
  • Global Rank Endpoint [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    A rank order response based on survival free from CV hospitalization and improvement in functional capacity measured by 6MWD.


Secondary Outcome Measures:
  • Six-minute Walk Distance [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Change in functional parameters as measured by 6-minute walk test (6MWT)

  • NT pro-BNP [ Time Frame: Baseline, 1 month, 6 months ] [ Designated as safety issue: No ]
    Change in neurohumoral activation as measured by N-terminal pro b-type natriuretic peptide

  • KCCQ [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    Patient-reported outcome of disease specific quality of life

  • Biomarkers [ Time Frame: Baseline, 1 month, 6 months ] [ Designated as safety issue: No ]
    Biomarkers of inflammation, cardiovascular and renal function (troponin I ultra-sensitive, hs-CRP, creatinine)

  • ECHO parameters [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Echocardiographic parameters, including LVEF and LVESVI for patients with HFrEF, and E/e' for patients with HFpEF

  • Win Ratio [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Sleep parameters [ Time Frame: 1 week, 1, 3, and 6 months ] [ Designated as safety issue: No ]
    Sleep and sleep disordered breathing parameters (AHI, nocturnal hypoxemia, CSR cycle length)

  • HF Hospitalization [ Time Frame: 2 days, 1 week, 1, 2, 3, and 6 months ] [ Designated as safety issue: Yes ]
    Rates of hospitalization or urgent clinic visit for worsening of heart failure and for any reason

  • Death [ Time Frame: 2 days, 1 week, 1, 2, 3, and 6 months ] [ Designated as safety issue: Yes ]
    Rate of Cardiovascular and all-cause death

  • Time dead/hospitalized [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Total days dead or hospitalized at study end

  • DASI [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Patient-reported outcome of disease specific quality of life

  • EQ-5D-5L [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Standardized self-report questionnaire that is used as a measure of general health outcome

  • PHQ-9 [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression

  • PSQI [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    A subjective measurement of the quality and patterns of sleep in the older adult

  • ESS [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    A self-administered questionnaire which provides a measurement of the general level of daytime sleepiness


Estimated Enrollment: 215
Study Start Date: December 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953874

Contacts
Contact: Lisa Hatch (919) 668-7516 lisa.hatch@duke.edu

Locations
United States, Colorado
VA Medical Center Recruiting
Denver, Colorado, United States, 80220
Principal Investigator: Brack Hattler, MD         
United States, Georgia
Mercer University Recruiting
Macon, Georgia, United States, 31201
Principal Investigator: Jalal Ghali, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Jonathan Rich, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Stephen Gottlieb, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Gregory Ewald, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Chetan Patel, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Principal Investigator: Stephanie Dunlap, MD         
United States, Pennsylvania
Penn State Hershey Recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: Barry Clemson, MD         
Jefferson Heart Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Paul Mather, MD         
Germany
Heart and Diabetes Center - North Rhine-Westphalia (HDZ-NRW) Recruiting
Bad Oeynhausen, Germany
Contact: Henrik Fox, MD         
Principal Investigator: Henrik Fox, MD         
Principal Investigator: Olaf Oldenburg, MD         
Sponsors and Collaborators
ResMed
ResMed Foundation
Investigators
Principal Investigator: Christopher O'Connor, MD Duke University
  More Information

No publications provided

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01953874     History of Changes
Other Study ID Numbers: MA-12-12-01
Study First Received: September 23, 2013
Last Updated: June 13, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

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:
Respiratory Aspiration
Heart Failure
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014