Clinical trial NCT01121107: Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy
Official title: Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Decompensated Heart Failure
Acute Decompensated Heart Failure
Hemodynamic Monitoring
Implantable Pressure Monitor
Left Atrial Pressure Monitoring
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-05-12
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this clinical study is to evaluate the safety and clinical effectiveness of use of a physician-directed, patient self-management system, guided by left atrial pressure measurements, for use in patients with heart failure. The system allows patients to adjust their HF medications daily based on a physician-directed prescription plan and their current HF status, similar to the manner in which diabetes patients manage their insulin therapy. The goal of the LAPTOP-HF study is to demonstrate reductions in episodes of worsening heart failure (HF) and hospitalizations in patients who are managed with the left atrial pressure (LAP) management system (treatment group) versus those who receive only the current standard of care (control group).

Detailed description: The Sponsor believes that direct measurements from your heart may provide an accurate, reliable and medically acceptable way of better managing your heart failure prior to your noticing symptoms or being hospitalized. This may enable you and your doctor to take preventative measures, by fine tuning your care including more frequently adjusting your medications with a goal of avoiding hospitalization.

Eligibility criteria: Inclusion Criteria:

* Have ischemic or non-ischemic cardiomyopathy with either a history of reduced or preserved ejection fraction and heart failure for at least 6 months.
* NYHA Class III documented at screening visit.
* Be receiving appropriate medical therapy for heart failure as per ACC/AHA guidelines (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and beta-blocker) for at least 3 months prior to the randomization visit. Subject has been on stable medications maximized to the subject's tolerance of ACE or ARB and beta-blockers as determined by the study investigator for at least 30 days prior to randomization. Stable is defined as no more than a 100% increase or 50% decrease in dose. These criteria may be waved if a subject is intolerant of ACE, ARB or beta-blockers, or these agents are not indicated under the Guidelines. Such intolerance or lack of indications must be documented.
* Have a minimum of one (1) prior hospital admission within the last 12 months for acute exacerbation of HF of at least one (1) calendar date change duration requiring intravenous or invasive HF therapy. If CRT device previously implanted, the heart failure hospitalization must be ≥ 30 days after CRT implantation. Alternatively, if patients have not had a heart failure hospitalization within the prior 12 months, they must have an elevated Brain Natriuretic Peptide (BNP) level of at least 400pg/ml or an N-terminal pro-BNP (NT-proBNP) level of at least 1,500pg/ml, according to local measurement at the time of screening (within 30 days of the screening visit/consent)
* Provide informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits.
* Are able to schedule Therapy Initiation within two weeks. Enrollment/Randomization may be delayed until this criterion is met.

Exclusion Criteria:

* Are under the age of 18 years.
* Are pregnant.
* Have intractable HF with resting symptoms despite maximal medical therapy (persistent NYHA Class IV and ACC/AHA HF Stage D). This includes patients receiving continuous or intermittent outpatient intravenous vasoactive medications (e.g., IV inotropes, IV vasodilators), patients treated with a ventricular assist device (VAD), and patients who have received a cardiac transplant or are listed for cardiac transplantation and likely to be transplanted within 12 months - even if their functional status has improved to NYHA Class III. Patients listed for cardiac transplantation who are not likely to be transplanted within 12 months and who have improved to NYHA Class III without outpatient IV vasoactive medications or a VAD are eligible for the study, if they meet the other inclusion/exclusion criteria.
* Have a resting systolic blood pressure \< 80 or \> 180 mmHg.
* Have an acute MI, Acute Coronary Syndrome, Percutaneous Coronary Intervention (PCI), new cardiac rhythm management device (Pacemaker, ICD, and CRT), CRM system revision, lead extraction or cardiac or other major surgery within 40 days.
* Have known coexisting, untreated, hemodynamically severe stenotic valve lesions, vegetations, hypertrophic cardiomyopathy with significant resting or provoked subaortic gradient, acute myocarditis, tamponade, or large pericardial effusion.
* Have an Atrial Septal Defect or Patent Foramen Ovale (with more than trace shunting on color Doppler or intravenous bubble study) or surgical correction of significant congenital heart disease involving atrial septum such as PFO or ASD closure device.
* Have a Stroke or Transient Ischemic Attack within 6 months.
* Have inadequate vascular access for device implantation.
* Have baseline 2-D echocardiographic evidence of, or history of, unresolved left atrial or ventricular thrombus.
* Have a recent (within 6 months) or persistent deep venous thrombosis, pulmonary or systemic thromboembolism.
* Have a life expectancy \< 1 year due to another illness.
* Have coagulopathy or uninterruptible anticoagulation therapy or contraindication for all of the forms of antiplatelet/anticoagulant treatments anticipated in the protocol.
* Have an Estimated Glomerular Filtration Rate that remains \< 30 ml/min/1.73 M2 by the MDRD method.
* Have a Liver Function Test \> 3 times upper limit of normal.
* Have Severe Pulmonary Disease producing frequent hospitalizations for respiratory distress and requiring continuous home oxygen.
* Have pulmonary hypertension with a pulmonary artery systolic pressure of greater than or equal to 80 mm/Hg on screening echocardiogram.
* Have an active infection requiring systemic antibiotics.
* Have a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.
* Are currently participating in a clinical investigation that includes an active treatment arm.
* Are unable to demonstrate understanding and capability of using the PAM patient advisory module appropriately.
* Patient does not have access to a telephone line usable for remote PAM follow-up or electrical outlet for recharging PAM.

Primary outcomes:
measure: Freedom from study-related major adverse cardiovascular and neurological events (MACNE)
timeFrame: 12 months
measure: Reduction in Relative Risk of Heart Failure Hospitalization
timeFrame: event driven
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cardiovascular Consultants Ltd
state: Arizona
city: Fullerton
country: United States
facility: St. Jude Hospital
state: California
city: Glendale
country: United States
facility: Glendale Memorial Hospital and Medical Center
state: California
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Memorial Hospital
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: Santa Rosa
country: United States
facility: Radiant Research
state: California
city: Jacksonville
country: United States
facility: Shands Jacksonville
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: The Emory Clinic - Crawford Long Hospital
state: Georgia
city: Atlanta
country: United States
facility: St. Joseph's Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Advocate Health and Hospitals Corporation
state: Illinois
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Kansas City
country: United States
facility: Mid-America Cardiology Associates, PC
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusettts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Trinity Health - Michigan d/b/a Michigan Heart
state: Michigan
city: Midland
country: United States
facility: MidMichigan Physicians Group
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital, Royal Oak
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lincoln
country: United States
facility: Bryan LGH Heart Institute
state: Nebraska
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Newark
country: United States
facility: University of Medicine & Dentistry of New Jersey
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Charlotte
country: United States
facility: Sanger Clinic
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Akron
country: United States
facility: Northeast Ohio Cardiovascular
state: Ohio
city: Cincinnati
country: United States
facility: The Linder Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Cleveland
country: United States
facility: VA Medical Center Cleveland
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research Group
state: Oklahoma
city: Portland
country: United States
facility: Providence Heart and Vascular Institute
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster Heart Foundation
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Singer Research Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
city: Wynnewood
country: United States
facility: Main Line Health Heart Center: Lankenau Hospitals
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: Methodist Hospital Research Institute
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Murray
country: United States
facility: Intermountain Heart Rhythm Specialists
state: Utah
city: Ogden
country: United States
facility: McKay-Dee Heart Services
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Norfolk
country: United States
facility: Sentara Hospitals and Sentara Cardiovascular Research Institute
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Sinai Medical Center
state: Wisconsin
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
Study officials:
affiliation: University of Rochester, Strong Memorial Hospital, Rochester, NY
name: Leway Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: USC University Hospital, Los Angeles, CA
name: Leslie Saxon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Glendale Memorial Hospital and Medical Center, Glendale, CA
name: John P. McKenzie III, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Iowa Heart Center, Des Moines, IA
name: Steven Bailin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mid-America Cardiology Associates, PC, Kansas City, KS
name: Dhanunjaya Lakkireddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ochsner Health System
name: Hamang Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Ayesha Hasan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oklahoma Cardiovascular Research Group, Oklahoma City, OK
name: Philip B. Adamson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shands Jacksonville, Jacksonville, FL
name: Steve Hsu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia Medical Center, Charlottesville, VA
name: John Ferguson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bryan LGH Heart Institute, Lincoln, NE
name: Steven Krueger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Heart Institute, Houston, TX
name: Andrew Civitello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts Medical Center, Worcester, MA
name: Theo Meyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Research, Santa Rosa, CA
name: Stephen W Halpern, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Intermountain Heart Rhythm Specialists, Murray, UT
name: Rami Alharethi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northeast Ohio Cardiovascular Specialists, Akron, OH
name: Otfried Neidermaier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Trinity Health-Michigan d/b/a Michigan Heart, Ann Arbor, MI
name: Marlo Leonen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pacific Heart Institute, Santa Monica, CA
name: Peter Pak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Advocate Health and Hospitals Corporation, Oakbrook Terrace, IL
name: Maria Rosa Costanzo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aurora Sinai Medical Center, Milwaukee, WI
name: Nasir Sulemanjee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky, Lexington, KY
name: John Gurley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Minneapolis Heart Institute, Minneapolis, MN
name: Barry Cabuay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Morristown Memorial Hospital, Morristown, NJ
name: Stephen Winters, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic Foundation, Cleveland, OH
name: Wilson Tang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Kimberly Parks, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University Hospital, Atlanta, GA
name: David Delurgio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph's Hospital, Atlanta, GA
name: Niraj Sharma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Memorial Hospital, Memphis, TN
name: Frank McGrew, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Lindner Center, Cincinnati, OH
name: Thomas O'Brien, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MidMichigan Physicians Group, Midland, MI
name: Peter Fattal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beaumont Hospital, Royal Oak, MI
name: Aaron Berman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sentara Norfolk General Hospital, Norfolk, VA
name: John Herre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Medicine & Dentistry of New Jersey, Newark, NJ
name: James Maher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Michael Craig, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern Memorial Hospital, Chicago, IL
name: Robert Gordon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Hospital, Nashville, TN
name: Daniel J Lenihan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scripps Green Hospital, La Jolla, CA
name: Thomas J. Heywood, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanger Clinic, Charlotte, NC
name: Rohit Mehta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Jude Hospital, Fullerton, CA
name: Daniel Landa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital, Boston, MA
name: Anju Nohria, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Hospital, Kansas City, MO
name: Mark Everley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christchurch Hospital, Christchurch, New Zealand
name: Richard Troughton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Allegheny Singer Research Institute, Pittsburgh, PA
name: George Sokos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Austin Heart, Austin, TX
name: Paul Coffeen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular Consultants Ltd, Phoenix, AZ
name: Ashish Gupta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center, Los Angeles, CA
name: Lawrence Czer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University Medical Center, Durham, NC
name: Joseph Rogers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital, Lancaster, PA
name: Tarek Nossuli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Main Line Health Center/Lankenau Hospital, Wynnewood, PA
name: Dusan Kocovic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State Milton S. Hershey Medical Center, Hershey, PA
name: John Boehmer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Cardiac Arrhythmia, Austin, TX
name: Jason Zagrodzky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Methodist Hospital, Houston, TX
name: Jerry Estep, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Medical Center Cleveland, Cleveland, OH
name: Mauricio Hong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Palo Alto Medical Center, Palo Alto, CA
name: Michael Pham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Pittsburgh Healthcare System, Pittsburgh, PA
name: Alaa Shalaby, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sutter Memorial Hospital, Sacramento, CA
name: Zi-Juan Xu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California at San Francisco
name: Liviu Klein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McKay-Dee Heart Services, Ogden, UT
name: Jerry John, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Hermann Hospital, Houston, TX
name: Pranav Loyalka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Greg Ewald, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampa General Hospital, Tampa, FL
name: Debbie A. Rinde-Hoffman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Louisiana State University Health Sciences Center, New Orleans, LA
name: Frank Smart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jewish Hospital, Louisville, KY
name: Kelly McCants, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Providence Heart and Vascular Institute, Portland, OR
name: Jacob Abraham, MD
role: PRINCIPAL_INVESTIGATOR
References: