Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)

• ClinicalTrials.gov Identifier: NCT03387813
• Recruitment Status: Active, not recruiting
• First Posted: January 2, 2018
• Last Update Posted: August 30, 2022
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Heart Failure; Heart Failure, Systolic; Heart Failure, Diastolic; Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure NYHA Class IV; Heart Failure，Congestive; Heart Failure With Reduced Ejection Fraction; Heart Failure With Normal Ejection Fraction; Heart Failure; With Decompensation	Device: CardioMEMS™ HF System	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2358 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Hemodynamic-GUIDEd Management of Heart Failure
• Actual Study Start Date: March 15, 2018
• Estimated Primary Completion Date: May 2023
• Estimated Study Completion Date: August 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: 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 Names: CardioMEMS; CardioMEMS PA Sensor; CardioMEMS HF System
Experimental: 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.	Device: 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 Names: CardioMEMS; CardioMEMS PA Sensor; CardioMEMS HF System
Experimental: Single Arm; Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.	Device: 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 Names: CardioMEMS; CardioMEMS PA Sensor; CardioMEMS HF System

Outcome Measures

Primary Outcome Measures :

1. (Randomized Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality [ Time Frame: 12 months post-implantation ]

   The composite of:

   1. The number of recurrent 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

2. (Single Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality [ Time Frame: 12 months post-implantation ]

   The composite outcome of:

   1. The number of recurrent 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

Secondary Outcome Measures :

1. (Randomized Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits [ Time Frame: 12 months post-implantation ]

   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

2. (Randomized Arm) EQ-5D-5L [ Time Frame: Baseline, 6, and 12 months post-implantation ]
   Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire
3. (Randomized Arm) KCCQ-12 [ Time Frame: Baseline, 6, and 12 months post-implantation ]
   Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
4. (Randomized Arm) 6MHW Test [ Time Frame: Baseline, 6, and 12 months post-implantation ]
   Six Minute Hall Walk (6MHW) Test Distance
5. (Randomized Arm) HFHs [ Time Frame: 12 months post-implantation ]
   The number of recurrent HFHs
6. (Randomized Arm) Intravenous diuretic visits [ Time Frame: 12 months post-implantation ]
   The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
7. (Randomized Arm) All-cause mortality [ Time Frame: 12 months post-implantation ]
   The number of deaths of any cause
8. (Randomized Arm) Safety: Freedom from DSRCs [ Time Frame: 12 months post-implantation ]
   Freedom from device/system related complications (DSRCs)
9. (Single Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits [ Time Frame: 12 months post-implantation ]

   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

10. (Single Arm) HFHs post- vs. pre-implantation [ Time Frame: 12 months post-implantation ]
    The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation
11. (Single Arm) HFHs [ Time Frame: 12 months post-implantation ]
    The number of HFHs
12. (Single Arm) Intravenous diuretic visits [ Time Frame: 12 months post-implantation ]
    The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
13. (Single Arm) All-cause mortality [ Time Frame: 12 months post-implantation ]
    The number of deaths of any cause
14. (Single Arm) Safety: Freedom from DSRCs [ Time Frame: 12 months post-implantation ]
    Freedom from DSRCs

Other Outcome Measures:

1. (Randomized Arm) Cardiovascular mortality [ Time Frame: 12 months post-implantation ]
   The number of deaths with cardiovascular cause
2. (Randomized Arm) All-cause hospitalizations [ Time Frame: 12 months post-implantation ]
   The number of hospitalizations of any cause
3. (Randomized Arm) Frequency of subject PA pressure uploads [ Time Frame: 12 months post-implantation ]
   The frequency of subject uploads of PA pressure
4. (Randomized Arm) Frequency of clinician review of subject PA pressure uploads [ Time Frame: 12 months post-implantation ]
   The frequency of clinician review of subject uploads of PA pressure
5. (Randomized Arm) HF medication changes [ Time Frame: 12 months post-implantation ]
   The number of changes in HF medications
6. (Randomized Arm) PA pressure measurements [ Time Frame: Baseline through 12 months post-implantation ]
   PA pressure measurements
7. (Randomized Arm) NT-proBNP (or BNP) [ Time Frame: Baseline, 6, and 12 months post-implantation ]
   NT-proBNP (or BNP) measurements
8. (Randomized Arm) HFHs post- vs. pre-implantation [ Time Frame: 12 months post-implantation ]
   The number of HFHs at 12 months post-implantation compared to the num ber of HFHs in the 12 months prior to implantation
9. (Single Arm) EQ-5D-5L [ Time Frame: Baseline, 6, and 12 months post-implantation ]
   Health status as assessed by the EQ-5D-5L Questionnaire
10. (Single Arm) KCCQ-12 [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    Health status as assessed by the KCCQ-12
11. (Single Arm) 6MHW Test [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    6MHW Test Distance
12. (Single Arm) Cardiovascular mortality [ Time Frame: 12 months post-implantation ]
    The number of deaths of cardiovascular cause
13. (Single Arm) All-cause hospitalizations [ Time Frame: 12 months post-implantation ]
    The number of hospitalizations of any cause
14. (Single Arm) Frequency of subject PA pressure uploads [ Time Frame: 12 months post-implantation ]
    The frequency of subject uploads of PA pressure
15. (Single Arm) Frequency of clinician review of subject PA pressure uploads [ Time Frame: 12 months post-implantation ]
    The frequency of clinician review of subject uploads of PA pressure
16. (Single Arm) HF medication changes [ Time Frame: 12 months post-implantation ]
    The number of changes in HF medications
17. (Single Arm) PA pressure measurements [ Time Frame: Baseline through 12 months post-implantation ]
    PA pressure measurements
18. (Single Arm) NT-proBNP (or BNP) [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    NT-proBNP (or BNP) measurements

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Diagnosis and treatment for heart failure (HF) (regardless of left ventricular ejection fraction (LVEF)) for > 90 days prior to the date of consent:

   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:

1. 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)
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

Contacts and Locations

Locations

United States, Arizona

Banner-University Medical Center Phoenix

Phoenix, Arizona, United States, 85006

Arizona Cardiovascular Research Center

Phoenix, Arizona, United States, 85016

Phoenix Cardiovascular Research Group

Phoenix, Arizona, United States, 85018

University of Arizona

Tucson, Arizona, United States, 85719

United States, Arkansas

Washington Regional Medical Center

Fayetteville, Arkansas, United States, 72703

Baptist Health Medical Center

Little Rock, Arkansas, United States, 72205

Arkansas Heart Hospital

Little Rock, Arkansas, United States, 72211

United States, California

John Muir Medical Center

Concord, California, United States, 94520

Adventist Health St. Helena

Deer Park, California, United States, 94574

Scripps Health

La Jolla, California, United States, 92037

University of California at San Diego (UCSD) Medical Center

La Jolla, California, United States, 92037

USC University Hospital

Los Angeles, California, United States, 90033

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States, 90095

Eisenhower Medical Center

Rancho Mirage, California, United States, 92270

Sutter Medical Center, Sacramento

Sacramento, California, United States, 95816

Mercy Medical Group - Cardiology

Sacramento, California, United States, 95819

San Diego Cardiac Center

San Diego, California, United States, 92123

California Pacific Medical Center - Van Ness Campus

San Francisco, California, United States, 94109

Ventura Cardiology Consultants

Ventura, California, United States, 93003

United States, Colorado

University of Colorado Hospital

Aurora, Colorado, United States, 80045

North Colorado Medical Center

Greeley, Colorado, United States, 80631

South Denver Cardiology Associates PC

Littleton, Colorado, United States, 80120

United States, Connecticut

Hartford Hospital

Hartford, Connecticut, United States, 06106

Yale New Haven Hospital

New Haven, Connecticut, United States, 06510

United States, District of Columbia

George Washington University Hospital

Washington, District of Columbia, United States, 20037

United States, Florida

Bethesda Memorial Hospital

Boynton Beach, Florida, United States, 33466

Morton Plant Hospital

Clearwater, Florida, United States, 33756

Memorial Regional Hospital

Hollywood, Florida, United States, 33020

First Coast Cardiovascular Institute

Jacksonville, Florida, United States, 32216

Memorial Hospital Jacksonville

Jacksonville, Florida, United States, 32216

Mercy Hospital

Miami, Florida, United States, 33133

Advent Health Orlando

Orlando, Florida, United States, 32803

Orlando Regional Medical Center

Orlando, Florida, United States, 32806

Tampa General Hospital

Tampa, Florida, United States, 33606

United States, Georgia

Piedmont Athens Regional Medical Center

Athens, Georgia, United States, 30606

University Hospital

Augusta, Georgia, United States, 30901

WellStar Kennestone Hospital

Marietta, Georgia, United States, 30060

United States, Illinois

Northshore University HealthSystem

Evanston, Illinois, United States, 60201

Midwest Cardiovascular Institute

Naperville, Illinois, United States, 60540

Advocate Health and Hospitals Corporation

Oakbrook Terrace, Illinois, United States, 60181

United States, Indiana

St. Vincent Hospital

Indianapolis, Indiana, United States, 46240

Heart Center of Lake County

Merrillville, Indiana, United States, 46410

United States, Iowa

Iowa Heart Center

West Des Moines, Iowa, United States, 50266

United States, Kansas

Kansas University Medical Center

Kansas City, Kansas, United States, 66160

Cardiovascular Research Institute of Kansas

Wichita, Kansas, United States, 67226

United States, Louisiana

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, United States, 70808

Cardiovascular Institute of the South

Houma, Louisiana, United States, 70361

Louisiana State University Health Sciences Center

New Orleans, Louisiana, United States, 70112

Ochsner Medical Center

New Orleans, Louisiana, United States, 70121

Advanced Cardiovascular Specialists

Shreveport, Louisiana, United States, 71105

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

University of Massachusetts

Worcester, Massachusetts, United States, 01655

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48104

McLaren Health Care Corporation

Auburn Hills, Michigan, United States, 48326

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Sparrow Clinical Research Institute

Lansing, Michigan, United States, 48912

MidMichigan Medical Center-Midland

Midland, Michigan, United States, 48640

Providence Hospital

Southfield, Michigan, United States, 48075

United States, Minnesota

Minneapolis Heart Institute

Minneapolis, Minnesota, United States, 55407

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, United States, 55455

Mayo Clinic

Rochester, Minnesota, United States, 55905

St. Cloud Hospital

Saint Cloud, Minnesota, United States, 56303

United States, Missouri

St. Luke's Hospital

Kansas City, Missouri, United States, 64111

North Kansas City Hospital

North Kansas City, Missouri, United States, 64116

Mercy Hospital St. Louis

Saint Louis, Missouri, United States, 63141

United States, Nebraska

BryanLGH Heart Institute

Lincoln, Nebraska, United States, 68506

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

United States, Nevada

Renown Regional Medical Center

Reno, Nevada, United States, 89502

United States, New Hampshire

Catholic Medical Center

Manchester, New Hampshire, United States, 03102

United States, New Jersey

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States, 08015

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Saint Barnabas Medical Center

Livingston, New Jersey, United States, 07039

Lourdes Cardiology Services

Voorhees, New Jersey, United States, 08043

United States, New Mexico

New Mexico Heart Institute

Albuquerque, New Mexico, United States, 87102

United States, New York

New York University Hospital

New York, New York, United States, 10016

Mount Sinai Hospital

New York, New York, United States, 10019

New York-Presbyterian/Columbia University

New York, New York, United States, 10032

Hudson Valley Cardiovascular Practice, P.C.

Poughkeepsie, New York, United States, 12601

Rochester General Hospital

Rochester, New York, United States, 14621

St. Francis Hospital

Roslyn, New York, United States, 11576

United States, North Carolina

Carolinas Medical Center

Charlotte, North Carolina, United States, 28203

Vidant Medical Center

Greenville, North Carolina, United States, 27835

NC Heart and Vascular Research

Raleigh, North Carolina, United States, 27607

WakeMed Hospital

Raleigh, North Carolina, United States, 27610

United States, Ohio

Akron City Hospital

Akron, Ohio, United States, 44309

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

The Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Ohio State University

Columbus, Ohio, United States, 43210

Ohio Health Research Institute

Columbus, Ohio, United States, 43214

St. Elizabeth Health Center

Youngstown, Ohio, United States, 44501

United States, Oklahoma

Integris Baptist Medical Center

Oklahoma City, Oklahoma, United States, 73112

Oklahoma Heart Hospital South

Oklahoma City, Oklahoma, United States, 73135

Oklahoma Heart Institute at Utica

Tulsa, Oklahoma, United States, 74133

United States, Oregon

Providence Heart and Vascular

Portland, Oregon, United States, 97225

United States, Pennsylvania

Abington Memorial Hospital

Abington, Pennsylvania, United States, 19001

Pinnacle Health System

Harrisburg, Pennsylvania, United States, 17105

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Lancaster General Hospital

Lancaster, Pennsylvania, United States, 17603

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States, 19141

Allegheny General Hospital - ASRI

Pittsburgh, Pennsylvania, United States, 15212

The Reading Hospital and Medical Center

West Reading, Pennsylvania, United States, 19611

Main Line Health Center/Lankenau Hospital

Wynnewood, Pennsylvania, United States, 19096

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

United States, South Carolina

Prisma Health-Midlands

Columbia, South Carolina, United States, 29203

Greenville Health System

Greenville, South Carolina, United States, 29605

United States, South Dakota

Sanford USD Medical Center

Sioux Falls, South Dakota, United States, 57117

United States, Tennessee

Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, United States, 37920

Methodist University Hospital

Memphis, Tennessee, United States, 38104

St Thomas Hospital

Nashville, Tennessee, United States, 37205

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

United States, Texas

Acension Texas Cardiovascular

Austin, Texas, United States, 78705

Austin Heart

Austin, Texas, United States, 78756

Baylor University Hospital

Dallas, Texas, United States, 75246

John Peter Smith Hospital

Fort Worth, Texas, United States, 76104

Park Plaza Hospital

Houston, Texas, United States, 77004

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

Houston, Texas, United States, 77030

Memorial Hermann Hospital

Houston, Texas, United States, 77030

The Methodist Hospital

Houston, Texas, United States, 77030

Methodist Healthcare System of San Antonio

San Antonio, Texas, United States, 78229

United States, Virginia

Virginia Heart - The Cardiovascular Group, P.C.

Falls Church, Virginia, United States, 22042

Sentara Norfolk General Hospital

Norfolk, Virginia, United States, 23507

Bon Secours Heart & Vascular Institute

Richmond, Virginia, United States, 23226

Winchester Medical Center

Winchester, Virginia, United States, 22601

United States, Washington

Providence Everett Medical Center

Everett, Washington, United States, 98206

Swedish Medical Center - Heart & Vascular

Seattle, Washington, United States, 98122

University of Washington Medical Center

Seattle, Washington, United States, 98195

United States, Wisconsin

Aurora Medical Group

Milwaukee, Wisconsin, United States, 53215

Waukesha Memorial Hospital

Waukesha, Wisconsin, United States, 53188

Aspirus Wausau Hospital

Wausau, Wisconsin, United States, 54401

Canada, Alberta

Foothills Medical Centre

Calgary, Alberta, Canada, T2N2T9

Canada, British Columbia

Vancouver General Hospital (U of BC)

Vancouver, British Columbia, Canada, V5Z 1M9

Canada, Ontario

Southlake Regional Health Centre

Newmarket, Ontario, Canada, L3Y 2P9

Toronto General Hospital

Toronto, Ontario, Canada, M5G 2C4

Sponsors and Collaborators

Abbott Medical Devices

Investigators

• Study Director: Nessa Johnson, PhD; Abbott

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03387813
• Other Study ID Numbers: CIP-10170
• First Posted: January 2, 2018
• Last Update Posted: August 30, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Abbott Medical Devices:

Heart Failure; Hemodynamic Monitoring; CardioMEMS; Pulmonary Artery Pressure

Additional relevant MeSH terms:

Heart Failure; Heart Failure, Systolic; Heart Failure, Diastolic; Heart Diseases; Cardiovascular Diseases