Study Results
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View full resultsBasic Information
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COMPLETED
NA
2358 participants
INTERVENTIONAL
2018-03-15
2023-05-17
Brief Summary
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Detailed Description
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The trial includes patients with New York Heart Association (NYHA) Class II, III, or IV HF who have an elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or an elevated Brain Natriuretic Peptide (BNP)) and/or a prior HF hospitalization (HFH).
The GUIDE-HF IDE trial will include approximately 3600 subjects at approximately 140 North American sites and consists of two arms: a Randomized Arm and a Single Arm.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Randomized Arm - Treatment Group
Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System.
All subjects will receive a CardioMEMS™ HF System.
CardioMEMS™ HF System
The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
Randomized Arm - Control Group
Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System.
All subjects will receive a CardioMEMS™ HF System.
CardioMEMS™ HF System
The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
Single Arm
Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System.
All subjects will receive a CardioMEMS™ HF System.
CardioMEMS™ HF System
The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
Interventions
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CardioMEMS™ HF System
The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
a. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented.
2. GUIDE-HF Randomized Arm Only: NYHA Class II, III or IV HF symptoms documented within 30 days prior to consent.
3. GUIDE-HF Single Arm Only: NYHA Class III HF symptoms documented within 30 days prior to consent.
4. HF hospitalization (HFH) within 12 months prior to consent and/or elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) within 30 days prior to consent defined as:
1. Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).
2. Subjects with LVEF \> 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL).
3. Thresholds for NT-proBNP and BNP (for both LVEF ≤ 40% and LVEF \> 40%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
5. ≥ 18 years of age
6. Chest circumference of \< 65 inches, if BMI is \> 35 kg/m2
7. Written informed consent obtained from subject
8. Willing and able to upload pulmonary artery (PA) pressure information and comply with the follow-up requirements
Exclusion Criteria
2. ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
3. Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 12 months
4. NYHA Class IV HF patients with:
1. Continuous or chronic use of scheduled intermittent inotropic therapy for HF and an INTERMACS level of ≤ 4, OR
2. Persistence of fluid overload with maximum (or dose equivalent) diuretic intervention
5. Glomerular Filtration Rate (eGFR) \< 25 mL/min and non-responsive to diuretic therapy, or receiving chronic dialysis
6. Inability to tolerate or receive dual antiplatelet therapy or anticoagulation therapy for one month post-implantation
7. Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS™ PA Sensor
8. Implanted with mechanical right heart valve(s)
9. Unrepaired severe valvular disease
10. Pregnant or planning to become pregnant in the next 12 months
11. An active, ongoing infection, defined as being febrile, an elevated white blood cell count, on intravenous antibiotics, and/or positive cultures (blood, sputum or urine).
12. History of current or recurrent (≥ 2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thrombosis
13. Major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent
14. Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to consent
15. Enrollment into another trial with an active treatment arm
16. Anticipated life expectancy of \< 12 months
17. Any condition that, in the opinion of the Investigator, would not allow for utilization of the CardioMEMS™ HF System to manage the subject using information gained from hemodynamic measurements to adjust medications, including the presence of unexpectedly severe pulmonary hypertension (e.g., trans-pulmonary gradient \>15) at implant right heart catheterization (RHC), a history of non-compliance, or any condition that would preclude CardioMEMS™ PA Sensor implantation
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Nessa Johnson, PhD
Role: STUDY_DIRECTOR
Abbott
Locations
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Banner-University Medical Center Phoenix
Phoenix, Arizona, United States
Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Washington Regional Medical Center
Fayetteville, Arkansas, United States
Baptist Health Medical Center
Little Rock, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
John Muir Medical Center
Concord, California, United States
Adventist Health St. Helena
Deer Park, California, United States
Scripps Health
La Jolla, California, United States
University of California at San Diego (UCSD) Medical Center
La Jolla, California, United States
USC University Hospital
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Sutter Medical Center, Sacramento
Sacramento, California, United States
Mercy Medical Group - Cardiology
Sacramento, California, United States
San Diego Cardiac Center
San Diego, California, United States
California Pacific Medical Center - Van Ness Campus
San Francisco, California, United States
Ventura Cardiology Consultants
Ventura, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
South Denver Cardiology Associates PC
Littleton, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
George Washington University Hospital
Washington D.C., District of Columbia, United States
Bethesda Memorial Hospital
Boynton Beach, Florida, United States
Morton Plant Hospital
Clearwater, Florida, United States
Memorial Regional Hospital
Hollywood, Florida, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Memorial Hospital Jacksonville
Jacksonville, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Piedmont Athens Regional Medical Center
Athens, Georgia, United States
University Hospital
Augusta, Georgia, United States
WellStar Kennestone Hospital
Marietta, Georgia, United States
Northshore University HealthSystem
Evanston, Illinois, United States
Advocate Health and Hospitals Corporation
Oakbrook Terrace, Illinois, United States
St. Vincent Hospital
Indianapolis, Indiana, United States
Heart Center of Lake County
Merrillville, Indiana, United States
Iowa Heart Center
West Des Moines, Iowa, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Advanced Cardiovascular Specialists
Shreveport, Louisiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
McLaren Health Care Corporation
Auburn Hills, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
MidMichigan Medical Center-Midland
Midland, Michigan, United States
Providence Hospital
Southfield, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Cloud Hospital
Saint Cloud, Minnesota, United States
St. Luke's Hospital
Kansas City, Missouri, United States
North Kansas City Hospital
North Kansas City, Missouri, United States
Mercy Hospital St. Louis
St Louis, Missouri, United States
BryanLGH Heart Institute
Lincoln, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Renown Regional Medical Center
Reno, Nevada, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Lourdes Cardiology Services
Voorhees Township, New Jersey, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
New York University Hospital
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
New York-Presbyterian/Columbia University
New York, New York, United States
Hudson Valley Cardiovascular Practice, P.C.
Poughkeepsie, New York, United States
Rochester General Hospital
Rochester, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Vidant Medical Center
Greenville, North Carolina, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
WakeMed Hospital
Raleigh, North Carolina, United States
Akron City Hospital
Akron, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
St. Elizabeth Health Center
Youngstown, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital South
Oklahoma City, Oklahoma, United States
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma, United States
Providence Heart and Vascular
Portland, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Pinnacle Health System
Harrisburg, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, United States
The Reading Hospital and Medical Center
West Reading, Pennsylvania, United States
Main Line Health Center/Lankenau Hospital
Wynnewood, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Prisma Health-Midlands
Columbia, South Carolina, United States
Greenville Health System
Greenville, South Carolina, United States
Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, United States
Methodist University Hospital
Memphis, Tennessee, United States
St Thomas Hospital
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Acension Texas Cardiovascular
Austin, Texas, United States
Austin Heart
Austin, Texas, United States
Baylor University Hospital
Dallas, Texas, United States
John Peter Smith Hospital
Fort Worth, Texas, United States
Park Plaza Hospital
Houston, Texas, United States
CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
Houston, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Methodist Healthcare System of San Antonio
San Antonio, Texas, United States
Virginia Heart - The Cardiovascular Group, P.C.
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Bon Secours Heart & Vascular Institute
Richmond, Virginia, United States
Winchester Medical Center
Winchester, Virginia, United States
Providence Everett Medical Center
Everett, Washington, United States
Swedish Medical Center - Heart & Vascular
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Aurora Medical Group
Milwaukee, Wisconsin, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Aspirus Wausau Hospital
Wausau, Wisconsin, United States
Foothills Medical Centre
Calgary, Alberta, Canada
Vancouver General Hospital (U of BC)
Vancouver, British Columbia, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Countries
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References
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Zile MR, Abraham WT, Stevenson LW, Costanzo MR, Angermann CE, Mehra MR, Desai AS, Ducharme A, Johnson N, Henderson J, Lindenfeld J. Relationship Between Remote, Ambulatory Pulmonary Artery Pressures, and All-Cause Mortality in Patients With Chronic Heart Failure. Circ Heart Fail. 2025 Jun;18(6):e012754. doi: 10.1161/CIRCHEARTFAILURE.124.012754. Epub 2025 Apr 14.
Desai AS, Maisel A, Mehra MR, Zile MR, Ducharme A, Paul S, Sears SF, Smart F, Bhatt K, Krim S, Henderson J, Johnson N, Adamson PB, Costanzo MR, Lindenfeld J; GUIDE-HF Investigators. Hemodynamic-Guided Heart Failure Management in Patients With Either Prior HF Hospitalization or Elevated Natriuretic Peptides. JACC Heart Fail. 2023 Jun;11(6):691-698. doi: 10.1016/j.jchf.2023.01.007. Epub 2023 Apr 12.
Zile MR, Mehra MR, Ducharme A, Sears SF, Desai AS, Maisel A, Paul S, Smart F, Grafton G, Kumar S, Nossuli TO, Johnson N, Henderson J, Adamson PB, Costanzo MR, Lindenfeld J. Hemodynamically-Guided Management of Heart Failure Across the Ejection Fraction Spectrum: The GUIDE-HF Trial. JACC Heart Fail. 2022 Dec;10(12):931-944. doi: 10.1016/j.jchf.2022.08.012. Epub 2022 Oct 12.
Zile MR, Desai AS, Costanzo MR, Ducharme A, Maisel A, Mehra MR, Paul S, Sears SF, Smart F, Chien C, Guha A, Guichard JL, Hall S, Jonsson O, Johnson N, Sood P, Henderson J, Adamson PB, Lindenfeld J. The GUIDE-HF trial of pulmonary artery pressure monitoring in heart failure: impact of the COVID-19 pandemic. Eur Heart J. 2022 Jul 14;43(27):2603-2618. doi: 10.1093/eurheartj/ehac114.
Lindenfeld J, Zile MR, Desai AS, Bhatt K, Ducharme A, Horstmanshof D, Krim SR, Maisel A, Mehra MR, Paul S, Sears SF, Sauer AJ, Smart F, Zughaib M, Castaneda P, Kelly J, Johnson N, Sood P, Ginn G, Henderson J, Adamson PB, Costanzo MR. Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial. Lancet. 2021 Sep 11;398(10304):991-1001. doi: 10.1016/S0140-6736(21)01754-2. Epub 2021 Aug 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CIP-10170
Identifier Type: -
Identifier Source: org_study_id
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