Cardiovascular Improvements With MV ASV Therapy in Heart Failure

NCT01953874 | Terminated Results DMC

• 1 other identifier: MA-12-12-01
• Study Type: interventional
• Target: 126
• Locations: 2 countries
• Sites: 15

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.

Conditions

Acute Decompensated Heart Failure; Sleep Disordered Breathing

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 months

Secondary Outcomes (19)

• Six-minute Walk Distance

  Change from Baseline to 6 months

• NT Pro-BNP

  Change from Baseline to 6 months

• Kansas City Cardiomyopathy Questionnaire (KCCQ)

  Change from Baseline to 6 months

• Biomarkers - Inflammation

  Change from Baseline to 6 months

• Biomarkers - Cardiovascular

  Change from Baseline to 6 months

Study Arms (2)

MV ASV+OMT

EXPERIMENTAL

Minute Ventilation-targeted adaptive servo-ventilation therapy plus optimized medical treatment

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.

Drug: Optimized Medical Treatment

Interventions

MV ASV DEVICE

Minute ventilation-targeted servo-ventilation therapy.

Also known as: VPAP Adapt, AutoSet CS

MV ASV+OMT

Optimized Medical Treatment DRUG

Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated

MV ASV+OMT; OMT only

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead
• ResMed Foundation: collaborator

Study Sites (15)

The Heart Center

Huntsville, Alabama, 35801, United States

Location

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

VA Medical Center

Denver, Colorado, 80220, United States

Location

Mercer University

Macon, Georgia, 31201, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Penn State Hershey

Hershey, Pennsylvania, 17033, United States

Location

Jefferson Heart Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Heart and Diabetes Center - North Rhine-Westphalia (HDZ-NRW)

Bad Oeynhausen, Germany

Location

Related Publications (3)

• 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.

  PMID: 30059750 DERIVED

• 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.

  PMID: 28335841 DERIVED

• 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.

  PMID: 26806668 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Heart Failure; Sleep Apnea, Central; Sleep Apnea, Obstructive; Cheyne-Stokes Respiration

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The trial was terminated early because of the unexpected safety signal reported in SERVE-HF.

Results Point of Contact

• Title: Adam Benjafield
• Organization: ResMed

adam.benjafield@resmed.com

(858)836-6782

Study Officials

• Christopher O'Connor, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: October 1, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 28, 2018
• Results First Posted: February 28, 2018

Record last verified: 2018-01

Locations

DE (1); US (14)