Clinical trial NCT03387813: Hemodynamic-GUIDEd Management of Heart Failure
Official title: Hemodynamic-GUIDEd Management of Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: Heart Failure
Hemodynamic Monitoring
CardioMEMS
Pulmonary Artery Pressure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2018-01-02
Enrollment: 2358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: (Randomized Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality
timeFrame: 12 months post-implantation
measure: (Single Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality
timeFrame: 12 months post-implantation
Secondary outcomes:
measure: (Randomized Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits
timeFrame: 12 months post-implantation
measure: (Randomized Arm) EQ-5D-5L
timeFrame: Baseline, 6, and 12 months post-implantation
measure: (Randomized Arm) KCCQ-12
timeFrame: Baseline, 6, and 12 months post-implantation
measure: (Randomized Arm) 6MHW Test
timeFrame: Baseline, 6, and 12 months post-implantation
measure: (Randomized Arm) HFHs
timeFrame: 12 months post-implantation
measure: (Randomized Arm) Intravenous diuretic visits
timeFrame: 12 months post-implantation
measure: (Randomized Arm) All-cause mortality
timeFrame: 12 months post-implantation
measure: (Randomized Arm) Safety: Freedom from DSRCs
timeFrame: 12 months post-implantation
measure: (Single Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits
timeFrame: 12 months post-implantation
measure: (Single Arm) HFHs post- vs. pre-implantation
timeFrame: 12 months post-implantation
measure: (Single Arm) HFHs
timeFrame: 12 months post-implantation
measure: (Single Arm) Intravenous diuretic visits
timeFrame: 12 months post-implantation
measure: (Single Arm) All-cause mortality
timeFrame: 12 months post-implantation
measure: (Single Arm) Safety: Freedom from DSRCs
timeFrame: 12 months post-implantation
Other outcomes:
measure: (Randomized Arm) Cardiovascular mortality
timeFrame: 12 months post-implantation
measure: (Randomized Arm) All-cause hospitalizations
timeFrame: 12 months post-implantation
measure: (Randomized Arm) Frequency of subject PA pressure uploads
timeFrame: 12 months post-implantation
measure: (Randomized Arm) Frequency of clinician review of subject PA pressure uploads
timeFrame: 12 months post-implantation
measure: (Randomized Arm) HF medication changes
timeFrame: 12 months post-implantation
measure: (Randomized Arm) PA pressure measurements
timeFrame: Baseline through 12 months post-implantation
measure: (Randomized Arm) NT-proBNP (or BNP)
timeFrame: Baseline, 6, and 12 months post-implantation
measure: (Randomized Arm) HFHs post- vs. pre-implantation
timeFrame: 12 months post-implantation
measure: (Single Arm) EQ-5D-5L
timeFrame: Baseline, 6, and 12 months post-implantation
measure: (Single Arm) KCCQ-12
timeFrame: Baseline, 6, and 12 months post-implantation
measure: (Single Arm) 6MHW Test
timeFrame: Baseline, 6, and 12 months post-implantation
measure: (Single Arm) Cardiovascular mortality
timeFrame: 12 months post-implantation
measure: (Single Arm) All-cause hospitalizations
timeFrame: 12 months post-implantation
measure: (Single Arm) Frequency of subject PA pressure uploads
timeFrame: 12 months post-implantation
measure: (Single Arm) Frequency of clinician review of subject PA pressure uploads
timeFrame: 12 months post-implantation
measure: (Single Arm) HF medication changes
timeFrame: 12 months post-implantation
measure: (Single Arm) PA pressure measurements
timeFrame: Baseline through 12 months post-implantation
measure: (Single Arm) NT-proBNP (or BNP)
timeFrame: Baseline, 6, and 12 months post-implantation
Locations:
city: Phoenix
country: United States
facility: Banner-University Medical Center Phoenix
state: Arizona
city: Phoenix
country: United States
facility: Arizona Cardiovascular Research Center
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Fayetteville
country: United States
facility: Washington Regional Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: Baptist Health Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Concord
country: United States
facility: John Muir Medical Center
state: California
city: Deer Park
country: United States
facility: Adventist Health St. Helena
state: California
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: La Jolla
country: United States
facility: University of California at San Diego (UCSD) Medical Center
state: California
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center, Sacramento
state: California
city: Sacramento
country: United States
facility: Mercy Medical Group - Cardiology
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - Van Ness Campus
state: California
city: Ventura
country: United States
facility: Ventura Cardiology Consultants
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Greeley
country: United States
facility: North Colorado Medical Center
state: Colorado
city: Littleton
country: United States
facility: South Denver Cardiology Associates PC
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Boynton Beach
country: United States
facility: Bethesda Memorial Hospital
state: Florida
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Jacksonville
country: United States
facility: Memorial Hospital Jacksonville
state: Florida
city: Miami
country: United States
facility: Mercy Hospital
state: Florida
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Athens
country: United States
facility: Piedmont Athens Regional Medical Center
state: Georgia
city: Augusta
country: United States
facility: University Hospital
state: Georgia
city: Marietta
country: United States
facility: WellStar Kennestone Hospital
state: Georgia
city: Evanston
country: United States
facility: Northshore University HealthSystem
state: Illinois
city: Naperville
country: United States
facility: Midwest Cardiovascular Institute
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Advocate Health and Hospitals Corporation
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Merrillville
country: United States
facility: Heart Center of Lake County
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Wichita
country: United States
facility: Cardiovascular Research Institute of Kansas
state: Kansas
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Hospital
state: Louisiana
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
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: Shreveport
country: United States
facility: Advanced Cardiovascular Specialists
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Auburn Hills
country: United States
facility: McLaren Health Care Corporation
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Midland
country: United States
facility: MidMichigan Medical Center-Midland
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center Fairview
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Cloud
country: United States
facility: St. Cloud Hospital
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: North Kansas City
country: United States
facility: North Kansas City Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
city: Lincoln
country: United States
facility: BryanLGH Heart Institute
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: Voorhees
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: New York
country: United States
facility: New York University Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: New York-Presbyterian/Columbia University
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Cardiovascular Practice, P.C.
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Greenville
country: United States
facility: Vidant Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Hospital
state: North Carolina
city: Akron
country: United States
facility: Akron City Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Youngstown
country: United States
facility: St. Elizabeth Health Center
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital South
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Heart Institute at Utica
state: Oklahoma
city: Portland
country: United States
facility: Providence Heart and Vascular
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health System
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital - ASRI
state: Pennsylvania
city: West Reading
country: United States
facility: The Reading Hospital and Medical Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Main Line Health Center/Lankenau Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Columbia
country: United States
facility: Prisma Health-Midlands
state: South Carolina
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
city: Knoxville
country: United States
facility: Tennova Healthcare - Turkey Creek Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Nashville
country: United States
facility: St Thomas Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Acension Texas Cardiovascular
state: Texas
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Dallas
country: United States
facility: Baylor University Hospital
state: Texas
city: Fort Worth
country: United States
facility: John Peter Smith Hospital
state: Texas
city: Houston
country: United States
facility: Park Plaza Hospital
state: Texas
city: Houston
country: United States
facility: CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare System of San Antonio
state: Texas
city: Falls Church
country: United States
facility: Virginia Heart - The Cardiovascular Group, P.C.
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Heart & Vascular Institute
state: Virginia
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Everett
country: United States
facility: Providence Everett Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center - Heart & Vascular
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Wausau Hospital
state: Wisconsin
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital (U of BC)
state: British Columbia
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Abbott
name: Nessa Johnson, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.