AzTrials
AzTrials

Heart FailureGUIDE-HFNCT03387813

Hemodynamic-GUIDEd Management of Heart Failure

A study testing CardioMEMS™ HF System in people with Heart Failure and Heart Failure, Systolic, run by Abbott Medical Devices at 129 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CardioMEMS™ HF System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,358 participants
Where
129 sitesin 2 countries
Study dates
15 Mar 2018to 17 May 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis and treatment for heart failure (HF) (regardless of left ventricular ejection fraction (LVEF)) for > 90 days prior to the date of consent:
  • 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.
  • GUIDE-HF Randomized Arm Only: NYHA Class II, III or IV HF symptoms documented within 30 days prior to consent.
  • GUIDE-HF Single Arm Only: NYHA Class III HF symptoms documented within 30 days prior to consent.
  • 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:
  • Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).
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  • Subjects with LVEF > 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL).
  • 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
  • ≥ 18 years of age
  • Chest circumference of < 65 inches, if BMI is > 35 kg/m2
  • Written informed consent obtained from subject
  • Willing and able to upload pulmonary artery (PA) pressure information and comply with the follow-up requirements

Who cannot join

  • Intolerance to all neuro-hormonal antagonists (i.e., intolerance to angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNi), hydralazine/isosorbide dinitrate and beta-blockers)
  • ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
  • Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 12 months
  • NYHA Class IV HF patients with:
  • Continuous or chronic use of scheduled intermittent inotropic therapy for HF and an INTERMACS level of ≤ 4, OR
  • Persistence of fluid overload with maximum (or dose equivalent) diuretic intervention
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  • Glomerular Filtration Rate (eGFR) < 25 mL/min and non-responsive to diuretic therapy, or receiving chronic dialysis
  • Inability to tolerate or receive dual antiplatelet therapy or anticoagulation therapy for one month post-implantation
  • Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS™ PA Sensor
  • Implanted with mechanical right heart valve(s)
  • Unrepaired severe valvular disease
  • Pregnant or planning to become pregnant in the next 12 months
  • 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).
  • History of current or recurrent (≥ 2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thrombosis
  • Major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent
  • Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to consent
  • Enrollment into another trial with an active treatment arm
  • Anticipated life expectancy of < 12 months
  • 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

Trial locations and contacts

129 sites in 2 countries.

129 sites in 2 countries

United States125 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Akron City Hospital

    Akron, Ohio, 44309

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102

  • University of Michigan

    Ann Arbor, Michigan, 48104

  • Piedmont Athens Regional Medical Center

    Athens, Georgia, 30606

  • McLaren Health Care Corporation

    Auburn Hills, Michigan, 48326

  • University Hospital

    Augusta, Georgia, 30901

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Acension Texas Cardiovascular

    Austin, Texas, 78705

  • Austin Heart

    Austin, Texas, 78756

  • Our Lady of the Lake Hospital

    Baton Rouge, Louisiana, 70808

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Bethesda Memorial Hospital

    Boynton Beach, Florida, 33466

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Prisma Health-Midlands

    Columbia, South Carolina, 29203

  • Ohio State University

    Columbus, Ohio, 43210

  • Ohio Health Research Institute

    Columbus, Ohio, 43214

  • John Muir Medical Center

    Concord, California, 94520

  • Baylor University Hospital

    Dallas, Texas, 75246

  • Adventist Health St. Helena

    Deer Park, California, 94574

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Northshore University HealthSystem

    Evanston, Illinois, 60201

  • Providence Everett Medical Center

    Everett, Washington, 98206

  • Virginia Heart - The Cardiovascular Group, P.C.

    Falls Church, Virginia, 22042

  • Washington Regional Medical Center

    Fayetteville, Arkansas, 72703

  • John Peter Smith Hospital

    Fort Worth, Texas, 76104

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Vidant Medical Center

    Greenville, North Carolina, 27835

  • Greenville Health System

    Greenville, South Carolina, 29605

  • Pinnacle Health System

    Harrisburg, Pennsylvania, 17105

  • Hartford Hospital

    Hartford, Connecticut, 06106

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Memorial Regional Hospital

    Hollywood, Florida, 33020

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70361

  • Park Plaza Hospital

    Houston, Texas, 77004

  • CHI St. Luke's Health Baylor College of Medicine Med. Ctr.

    Houston, Texas, 77030

  • Memorial Hermann Hospital

    Houston, Texas, 77030

  • The Methodist Hospital

    Houston, Texas, 77030

  • St. Vincent Hospital

    Indianapolis, Indiana, 46240

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32216

  • Memorial Hospital Jacksonville

    Jacksonville, Florida, 32216

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Tennova Healthcare - Turkey Creek Medical Center

    Knoxville, Tennessee, 37920

  • Scripps Health

    La Jolla, California, 92037

  • University of California at San Diego (UCSD) Medical Center

    La Jolla, California, 92037

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17603

  • BryanLGH Heart Institute

    Lincoln, Nebraska, 68506

  • Baptist Health Medical Center

    Little Rock, Arkansas, 72205

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • South Denver Cardiology Associates PC

    Littleton, Colorado, 80120

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • USC University Hospital

    Los Angeles, California, 90033

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • Catholic Medical Center

    Manchester, New Hampshire, 03102

  • WellStar Kennestone Hospital

    Marietta, Georgia, 30060

  • Methodist University Hospital

    Memphis, Tennessee, 38104

  • Heart Center of Lake County

    Merrillville, Indiana, 46410

  • MidMichigan Medical Center-Midland

    Midland, Michigan, 48640

  • Aurora Medical Group

    Milwaukee, Wisconsin, 53215

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • University of Minnesota Medical Center Fairview

    Minneapolis, Minnesota, 55455

  • St Thomas Hospital

    Nashville, Tennessee, 37205

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • Louisiana State University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • New York University Hospital

    New York, New York, 10016

  • Mount Sinai Hospital

    New York, New York, 10019

  • New York-Presbyterian/Columbia University

    New York, New York, 10032

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • Advocate Health and Hospitals Corporation

    Oakbrook Terrace, Illinois, 60181

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • Oklahoma Heart Hospital South

    Oklahoma City, Oklahoma, 73135

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Advent Health Orlando

    Orlando, Florida, 32803

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Banner-University Medical Center Phoenix

    Phoenix, Arizona, 85006

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona, 85016

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona, 85018

  • Allegheny General Hospital - ASRI

    Pittsburgh, Pennsylvania, 15212

  • Providence Heart and Vascular

    Portland, Oregon, 97225

  • Hudson Valley Cardiovascular Practice, P.C.

    Poughkeepsie, New York, 12601

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • NC Heart and Vascular Research

    Raleigh, North Carolina, 27607

  • WakeMed Hospital

    Raleigh, North Carolina, 27610

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Bon Secours Heart & Vascular Institute

    Richmond, Virginia, 23226

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Rochester General Hospital

    Rochester, New York, 14621

  • St. Francis Hospital

    Roslyn, New York, 11576

  • Sutter Medical Center, Sacramento

    Sacramento, California, 95816

  • Mercy Medical Group - Cardiology

    Sacramento, California, 95819

  • St. Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Methodist Healthcare System of San Antonio

    San Antonio, Texas, 78229

  • San Diego Cardiac Center

    San Diego, California, 92123

  • California Pacific Medical Center - Van Ness Campus

    San Francisco, California, 94109

  • Swedish Medical Center - Heart & Vascular

    Seattle, Washington, 98122

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Advanced Cardiovascular Specialists

    Shreveport, Louisiana, 71105

  • Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117

  • Providence Hospital

    Southfield, Michigan, 48075

  • Mercy Hospital St. Louis

    St Louis, Missouri, 63141

  • Tampa General Hospital

    Tampa, Florida, 33606

  • University of Arizona

    Tucson, Arizona, 85719

  • Oklahoma Heart Institute at Utica

    Tulsa, Oklahoma, 74133

  • Ventura Cardiology Consultants

    Ventura, California, 93003

  • Lourdes Cardiology Services

    Voorhees Township, New Jersey, 08043

  • George Washington University Hospital

    Washington D.C., District of Columbia, 20037

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Aspirus Wausau Hospital

    Wausau, Wisconsin, 54401

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

  • The Reading Hospital and Medical Center

    West Reading, Pennsylvania, 19611

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, 67226

  • Winchester Medical Center

    Winchester, Virginia, 22601

  • University of Massachusetts

    Worcester, Massachusetts, 01655

  • Main Line Health Center/Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • St. Elizabeth Health Center

    Youngstown, Ohio, 44501

Other trials in United States

Canada4 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N2T9

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Vancouver General Hospital (U of BC)

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.

Read the detailed description

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality.

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.

Being tested
CardioMEMS™ HF System
Keywords
Heart Failure, Hemodynamic Monitoring, CardioMEMS, Pulmonary Artery Pressure
Medical subject headings
Heart Failure, Heart Failure, Systolic, Heart Failure, Diastolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CardioMEMS™ HF SystemDevice

    Also called CardioMEMS, CardioMEMS PA Sensor, 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.

Study groups in NCT03387813
Study groupRoleWhat they receive
Randomized Arm - Treatment GroupExperimentalManagement of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.
Receives: Device: CardioMEMS™ HF System
Randomized Arm - Control GroupExperimentalManagement 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.
Receives: Device: CardioMEMS™ HF System
Single ArmExperimentalManagement of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.
Receives: Device: CardioMEMS™ HF System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality

    The composite of:

    1. The number of recurrent heart failure hospitalizations (HFHs)
    2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP)
    3. The number of deaths of any cause added together with equal weighting into a total number of events

    Measured: 12 months post-implantation (395 days after implant date)

  2. (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]

    The composite of:

    1. The number of recurrent heart failure hospitalizations (HFHs)
    2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP)
    3. The number of deaths of any cause added together with equal weighting into a total number of events.

    Measured: The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).

  3. (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]

    The composite of:

    1. The number of recurrent heart failure hospitalizations (HFHs)
    2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP)
    3. The number of deaths of any cause added together with equal weighting into a total number of events.

    Measured: 12 Months Post Implantation

  4. (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]

    The composite of:

    1. The number of recurrent heart failure hospitalizations (HFHs)
    2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP)
    3. The number of deaths of any cause added together with equal weighting into a total number of events.

    Measured: 12 Months Post-Implantation

  5. (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality

    The composite outcome of:

    1. The number of recurrent heart failure hospitalizations (HFHs)
    2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
    3. The number of deaths of any cause added together with equal weighting into a total number of events

    Measured: 12 months post-implantation (395 days after implant date)

  6. (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]

    The composite outcome of:

    1. The number of recurrent heart failure hospitalizations (HFHs)
    2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
    3. The number of deaths of any cause added together with equal weighting into a total number of events

    Measured: Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).

  7. (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]

    The composite outcome of:

    1. The number of recurrent heart failure hospitalizations (HFHs)
    2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
    3. The number of deaths of any cause added together with equal weighting into a total number of events

    Measured: 12 Months Post Implantation

  8. (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]

    The composite outcome of:

    1. The number of recurrent heart failure hospitalizations (HFHs)
    2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
    3. The number of deaths of any cause added together with equal weighting into a total number of events

    Measured: 12 Months Post Implantation

Secondary outcomes (43)

  1. (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits

    The composite outcome of:

    1. The number of recurrent heart failure hospitalizations (HFHs)
    2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events

    Measured: 12 months post-implantation

  2. (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis)

    The composite outcome of:

    1. The number of recurrent heart failure hospitalizations (HFHs)
    2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events

    Measured: The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).

  3. (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis)

    The composite outcome of:

    1. The number of recurrent heart failure hospitalizations (HFHs)
    2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events

    Measured: 12 Months Post Implantation

  4. (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis)

    The composite outcome of:

    1. The number of recurrent heart failure hospitalizations (HFHs)
    2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events

    Measured: 12 Months Post Implantation

  5. (Randomized Arm) HFHs

    The number of recurrent HFHs

    Measured: 12 months post-implantation

  6. (Randomized Arm) HFHs [Follow-up Based COVID-19 Sensitivity Analysis]

    The number of recurrent HFHs

    Measured: The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).

  7. (Randomized Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis]

    The number of recurrent HFHs

    Measured: 12 Months Post-Implantation

  8. (Randomized Arm) HFHs [Event Based COVID-19 Sensitivity Analysis]

    The number of recurrent HFHs

    Measured: 12 Months Post Implantation

  9. (Randomized Arm) Intravenous Diuretic Visits

    The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

    Measured: 12 months post-implantation

  10. (Randomized Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]

    The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

    Measured: The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).

  11. (Randomized Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]

    The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

    Measured: 12 Months Post Implantation

  12. (Randomized Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]

    The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

    Measured: 12 Months Post-Implantation

  13. (Randomized Arm) All-cause Mortality

    The number of deaths of any cause

    Measured: 12 months post-implantation

  14. (Randomized Arm) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]

    The number of deaths of any cause

    Measured: The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).

  15. (Randomized Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]

    The number of deaths of any cause

    Measured: 12 Months Post-Implantation

  16. (Randomized Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]

    The number of deaths of any cause

    Measured: 12 Months Post-Implantation

  17. (Randomized Arm) KCCQ-12

    Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status.

    Change from baseline KCCQ-12 scores were evaluated at 6 and 12-month visits.

    Measured: Baseline, 6, and 12 months post-implantation

  18. (Randomized Arm) KCCQ-12 (Subject Based COVID-19 Sensitivity Analysis)

    Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status.

    Descriptive statistics of KCCQ-12 scores at baseline, 6 and 12-month visits were reported.

    Measured: Baseline, 6, and 12 months post-implantation

  19. (Randomized Arm) EQ-5D-5L

    Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire

    The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life.

    Measured: Baseline, 6, and 12 months post-implantation

  20. (Randomized Arm) EQ-5D-5L (Subject Based COVID-19 Sensitivity Analysis)

    Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life.

    Measured: Baseline, 6, and 12 months post-implantation

  21. (Randomized Arm) 6MHW Test

    Six Minute Hall Walk (6MHW) Test Distance

    Measured: Baseline, 6, and 12 months post-implantation

  22. (Randomized Arm) 6MHW Test (Subject Based COVID-19 Sensitivity Analysis)

    Six Minute Hall Walk (6MHW) Test Distance

    Measured: Baseline, 6, and 12 months post-implantation

  23. (Randomized Arm) Safety: Freedom From DSRCs

    Freedom from device/system related complications (DSRCs)

    Measured: 12 months post-implantation

  24. (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits

    The composite outcome of:

    1. The number of recurrent HFHs
    2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events

    Measured: 12 months post-implantation

  25. (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]

    The composite outcome of:

    1. The number of recurrent HFHs
    2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events

    Measured: Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).

  26. (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]

    The composite outcome of:

    1. The number of recurrent HFHs
    2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events

    Measured: 12 Months Post Implantation

  27. (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]

    The composite outcome of:

    1. The number of recurrent HFHs
    2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events

    Measured: 12 Months Post Implantation

  28. (Single Arm) Intravenous Diuretic Visits

    The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy

    Measured: 12 months post-implantation

  29. (Single Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]

    The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy

    Measured: Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).

  30. (Single Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]

    The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy

    Measured: 12 months post-implantation

  31. (Single Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]

    The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy

    Measured: 12 Months Post Implantation

  32. (Single Arm) HFHs

    The number of HFHs

    Measured: 12 months post-implantation

  33. (Single Arm) HFHs [Follow-Up Based COVID-19 Sensitivity Analysis]

    The number of heart failure hospitalizations (HFHs)

    Measured: Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).

  34. (Single Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis]

    The number of heart failure hospitalizations (HFHs)

    Measured: 12 Months Post Implantation

  35. (Single Arm) HFHs [Event Based COVID-19 Sensitivity Analysis]

    The number of heart failure hospitalizations (HFHs)

    Measured: 12 Months Post Implantation

  36. (Single Arm) All-cause Mortality

    The number of deaths of any cause

    Measured: 12 months post-implantation

  37. (Single Arm) All-cause Mortality [Follow-Up Based COVID-19 Sensitivity Analysis]

    The number of deaths of any cause

    Measured: Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).

  38. (Single Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]

    The number of deaths of any cause

    Measured: 12 Months Post Implantation

  39. (Single Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]

    The number of deaths of any cause

    Measured: 12 Months Post Implantation

  40. (Single Arm) Safety: Freedom From DSRCs

    Proportion of subjects with freedom from device/system related complications (DSRCs)

    Measured: 12 months post-implantation

  41. (Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP Only Group]

    The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation

    Measured: 12 months post-implantation vs 12 months pre-implantation

  42. (Single Arm) HFHs Post- vs. Pre-implantation [Previous HF Hospitalization Only Group]

    The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation

    Measured: 12 months post-implantation vs 12 months pre-implantation

  43. (Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP and Previous HF Hospitalization Group]

    The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation

    Measured: 12 months post-implantation vs 12 months pre-implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2018
  2. Study start15 Mar 2018
  3. Primary completion17 May 2023
  4. Study completion17 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
2,358 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03387813
Sponsor's protocol ID
CIP-10170
Acronym
GUIDE-HF
Status last verified
Jul 2025
First submitted
12 Dec 2017
Last updated
7 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Desai AS, Zile MR, Ducharme A, Mehra MR, Maisel AS, Sears SF, Costanzo MR, Smart FW, Chien CV, Jonsson O, Hall S, Nie H, Lee FS, Lindenfeld J. Changes in Pulmonary Artery Pressure Following Initiation of Guideline-Directed Medical Therapies in Patients With Heart Failure: Insights From GUIDE-HF. Circ Heart Fail. 2026 Jun;19(6):e013877. doi: 10.1161/CIRCHEARTFAILURE.125.013877. Epub 2026 May 28.

    PubMed 42206402

  • 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.

    PubMed 40223608

  • 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.

    PubMed 37286262

  • 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.

    PubMed 36456066

  • 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.

    PubMed 35266003

  • 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.

    PubMed 34461042

Questions about this trial

What is this clinical trial studying?

A study testing CardioMEMS™ HF System in people with Heart Failure and Heart Failure, Systolic, run by Abbott Medical Devices at 129 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality (time frame: 12 months post-implantation (395 days after implant date)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03387813, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.

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