Clinical trial NCT03579641: Precision Event Monitoring for Patients With Heart Failure Using HeartLogic
Official title: Precision Event Monitoring for Patients With Heart Failure Using HeartLogic: PREEMPT-HF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Defibrillators, Implantable
Monitoring, Physiologic
Cardiac Resynchronization Therapy
Cardiovascular Disease
Heart Disease
Keywords: Heart Failure
Implantable Cardioverter Defibrillator
Cardiac Resynchronization Therapy Defibrillator
Heart Failure Sensor Data
30-day Heart Failure Readmission
Ventricular Tachycardia/Ventricular Fibrillation Therapy
Non-Heart Failure Hospitalization
HeartLogic Feature
Latitude Remote Patient Monitor
Data Linkage
Sleep Incline Sensor
Respiratory Sensor
Decongestive Intravenous therapy
Decompensation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-07-06
Enrollment: 2184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Heart Failure implanted with Boston Scientific Cardiac Resynchronization Therapy Defibrillator or Implantable Cardioverter Defibrillator using HeartLogic

Brief summary: The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator. There are no primary safety and/or efficacy endpoints for this study.

Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet clinical need to slow the progression of Heart Failure and prevent hospitalizations. HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators, combines novel sensor parameters such as heart sounds and respiration with other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index for the early detection of worsening Heart Failure. However, there is limited data on the association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or for phenotyping the broad spectrum of Heart Failure patients.

Detailed description: Subjects will be followed for approximately 12 months after the baseline visit to collect the required number of clinical events to support the study objectives. These events are called Reviewable Clinical Events, and include all-cause hospitalizations and Heart Failure outpatient visits.

Clinical event definitions are as follows:

* Hospitalization (all-cause): the subject is admitted to inpatient hospital care and discharged on a different calendar date.
* Heart Failure Hospitalization: the subject is admitted with signs/symptoms of congestive heart failure and receives unscheduled augmented Heart Failure therapy with oral or intravenous medications, ultrafiltration therapy or other parenteral therapy.
* Heart Failure Readmission (30-day): the subject is admitted for an unplanned hospitalization for any cause within 30 days post discharge from a Heart Failure hospitalization.
* Heart Failure Outpatient Visit: the subject has signs/symptoms of Congestive Heart Failure, and receives unscheduled intravenous decongestive therapy (e.g., Intravenous diuretics, Intravenous inotropes, Intravenous vasoactive drugs, ultrafiltration) in a setting that does not involve a hospitalization (e.g., emergency room, Heart Failure clinic, primary care clinic, etc.).

Eligibility criteria: Inclusion Criteria:

* Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws.
* Subject has a documented diagnosis of heart failure.
* Subject has a Boston Scientific Cardiac Resynchronization Therapy Defibrillator or Implantable Cardioverter Defibrillator device implant that has HeartLogic, with Heart Failure Sensors turned ON, Respiratory Sensor turned ON, and Sleep Incline Sensor turned ON.
* Subject has an active bipolar right ventricle lead implant.
* Subject is enrolled in LATITUDE (NXT 5.0 or future version), and is willing to be remotely monitored from the baseline visit for approximately 12 months with HeartLogic disabled.

Exclusion Criteria:

* Subject has received or is scheduled to receive a heart transplant or ventricular assist device (VAD).
* Subject is enrolled in any concurrent clinical study without prior Boston Scientific written approval (excluding registries).
* Subject has a life expectancy of less than 12 months.
* Subject has a history of non-compliance to medical care or known inability to comply with requirements of the clinical study protocol

Primary outcomes:
measure: Association of HeartLogic sensors with 30-day HF re-admission
timeFrame: Heartlogic sensor data will be evaluated for the association to HF re-admission during the 30 days after the index event (e.g. the first HF hospitalization that occurs during the trial).
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Baptist Medical Center Princeton
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Jonesboro
country: United States
facility: Cardiology Associates of Northeast Arkansas
state: Arkansas
city: Little Rock
country: United States
facility: Baptist Health Medical Center (Little Rock)
state: Arkansas
city: Burbank
country: United States
facility: Providence St. Joseph Medical Center
state: California
city: Mission Viejo
country: United States
facility: Mission Hospital
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Newark
country: United States
facility: Cardiology Physicians, PA
state: Delaware
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center for Research, Inc.
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Winter Park
country: United States
facility: Florida Hospital
state: Florida
city: Chicago
country: United States
facility: CorVita Science Foundation (NFP)
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: Evanston Hospital
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: University of Maryland Medical System
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Leominster
country: United States
facility: Mass Heart and Rhythm
state: Massachusetts
city: Flint
country: United States
facility: Advanced Cardiovascular Clinic
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Duluth
country: United States
facility: St. Luke's Hospital-Duluth
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic, P.A.
state: Mississippi
city: Hattiesburg
country: United States
facility: Heart and Vascular Hattiesburg Clinic
state: Mississippi
city: Pontiac
country: United States
facility: St. Joseph Mercy Hospital Oakland
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Albany
country: United States
facility: Capital Cardiology Associates
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: Strong Memorial Hospital of the University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Medford
country: United States
facility: Southern Oregon Cardiology, LLC
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: St. Francis Health System - St. Francis Hospital
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Seton Medical Center
state: Texas
city: Dallas
country: United States
facility: The University of Texas, Southwestern Medical Center
state: Texas
city: Pasadena
country: United States
facility: Orion Medical
state: Texas
city: Tyler
country: United States
facility: Christus Trinity Mother Frances Health System
state: Texas
city: Newport News
country: United States
facility: Riverside Regional Medical Center
state: Virginia
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
city: Chermside
country: Australia
facility: Prince Charles Hospital
city: Aalst
country: Belgium
facility: OLVZ Aalst
city: Montréal
country: Canada
facility: CHUM
city: Ste-Foy
country: Canada
facility: IUCPQ
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Caen
country: France
facility: CHU de Caen
city: Nantes
country: France
facility: CHU de Nantes - Hôpital Laennec
city: Paris
country: France
facility: APHP - Hospital de la Pitie-Salpetriere
city: Saint-Priest-en-Jarez
country: France
facility: CHU de St. Etienne
city: Bochum
country: Germany
facility: Augusta Kranken Anstalt GmbH - Klinik für Kardiologie und Angiologie
city: Lübeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Aberdeen
country: Hong Kong
facility: Grantham Hospital
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Waterford
country: Ireland
facility: University Hospital Waterford
city: Catanzaro
country: Italy
facility: Az. Osp. G. Ciaccio Pontepiccolo
city: Naples
country: Italy
facility: Az. Osp. Monaldi
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore Don Calabria
city: Verona
country: Italy
facility: Azienda Osp Univ Integrata di Verona
city: Amsterdam
country: Netherlands
facility: AMC
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Las Palmas
country: Spain
facility: Hospital de Gran Canaria Dr. Negrin
city: Málaga
country: Spain
facility: Hospital Universitario Virgen De La Victoria
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Manchester
country: United Kingdom
facility: South Manchester University Hospital Trust
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Boston Scientific Corporation
name: Stephen Gaertner
role: STUDY_DIRECTOR
References:
citation: Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
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citation: Whellan DJ, Lindenfeld J. Easy to Predict, Difficult to Prevent. JACC Heart Fail. 2017 Mar;5(3):226-228. doi: 10.1016/j.jchf.2017.01.006. No abstract available.
citation: Desai AS. The three-phase terrain of heart failure readmissions. Circ Heart Fail. 2012 Jul 1;5(4):398-400. doi: 10.1161/CIRCHEARTFAILURE.112.968735. No abstract available.
citation: Dharmarajan K, Wang Y, Lin Z, Normand ST, Ross JS, Horwitz LI, Desai NR, Suter LG, Drye EE, Bernheim SM, Krumholz HM. Association of Changing Hospital Readmission Rates With Mortality Rates After Hospital Discharge. JAMA. 2017 Jul 18;318(3):270-278. doi: 10.1001/jama.2017.8444.
citation: Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, Bonow RO, Huang CC, Deo RC. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015 Jan 20;131(3):269-79. doi: 10.1161/CIRCULATIONAHA.114.010637. Epub 2014 Nov 14.