Hemodynamic-GUIDEd Management of Heart Failure

Heart Failure Clinical Trial

— GUIDE-HF  

Official title:

Hemodynamic-GUIDEd Management of Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387813
• Other study ID #: CIP-10170
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: May 17, 2023

Study information

• Verified date: August 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2358
• Est. completion date: May 17, 2023
• Est. primary completion date: May 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure NYHA Class II
• Heart Failure NYHA Class III
• Heart Failure NYHA Class IV
• Heart Failure With Normal Ejection Fraction
• Heart Failure With Reduced Ejection Fraction
• Heart Failure, Diastolic
• Heart Failure, Systolic
• Heart Failure,Congestive
• Heart Failure; With Decompensation

Intervention

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.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Vancouver General Hospital (U of BC)	Vancouver	British Columbia
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Akron City Hospital	Akron	Ohio
United States	New Mexico Heart Institute	Albuquerque	New Mexico
United States	University of Michigan	Ann Arbor	Michigan
United States	Piedmont Athens Regional Medical Center	Athens	Georgia
United States	McLaren Health Care Corporation	Auburn Hills	Michigan
United States	University Hospital	Augusta	Georgia
United States	University of Colorado Hospital	Aurora	Colorado
United States	Acension Texas Cardiovascular	Austin	Texas
United States	Austin Heart	Austin	Texas
United States	Our Lady of the Lake Hospital	Baton Rouge	Louisiana
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Bethesda Memorial Hospital	Boynton Beach	Florida
United States	Deborah Heart and Lung Center	Browns Mills	New Jersey
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Morton Plant Hospital	Clearwater	Florida
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Prisma Health-Midlands	Columbia	South Carolina
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Ohio State University	Columbus	Ohio
United States	John Muir Medical Center	Concord	California
United States	Baylor University Hospital	Dallas	Texas
United States	Adventist Health St. Helena	Deer Park	California
United States	Henry Ford Hospital	Detroit	Michigan
United States	Northshore University HealthSystem	Evanston	Illinois
United States	Providence Everett Medical Center	Everett	Washington
United States	Virginia Heart - The Cardiovascular Group, P.C.	Falls Church	Virginia
United States	Washington Regional Medical Center	Fayetteville	Arkansas
United States	John Peter Smith Hospital	Fort Worth	Texas
United States	North Colorado Medical Center	Greeley	Colorado
United States	Greenville Health System	Greenville	South Carolina
United States	Vidant Medical Center	Greenville	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Pinnacle Health System	Harrisburg	Pennsylvania
United States	Hartford Hospital	Hartford	Connecticut
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Memorial Regional Hospital	Hollywood	Florida
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	CHI St. Luke's Health Baylor College of Medicine Med. Ctr.	Houston	Texas
United States	Memorial Hermann Hospital	Houston	Texas
United States	Park Plaza Hospital	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	Memorial Hospital Jacksonville	Jacksonville	Florida
United States	Kansas University Medical Center	Kansas City	Kansas
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Tennova Healthcare - Turkey Creek Medical Center	Knoxville	Tennessee
United States	Scripps Health	La Jolla	California
United States	University of California at San Diego (UCSD) Medical Center	La Jolla	California
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	BryanLGH Heart Institute	Lincoln	Nebraska
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Baptist Health Medical Center	Little Rock	Arkansas
United States	South Denver Cardiology Associates PC	Littleton	Colorado
United States	Saint Barnabas Medical Center	Livingston	New Jersey
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	USC University Hospital	Los Angeles	California
United States	Catholic Medical Center	Manchester	New Hampshire
United States	WellStar Kennestone Hospital	Marietta	Georgia
United States	Methodist University Hospital	Memphis	Tennessee
United States	Heart Center of Lake County	Merrillville	Indiana
United States	Mercy Hospital	Miami	Florida
United States	MidMichigan Medical Center-Midland	Midland	Michigan
United States	Aurora Medical Group	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
United States	Midwest Cardiovascular Institute	Naperville	Illinois
United States	St Thomas Hospital	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Louisiana State University Health Sciences Center	New Orleans	Louisiana
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Mount Sinai Hospital	New York	New York
United States	New York University Hospital	New York	New York
United States	New York-Presbyterian/Columbia University	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	North Kansas City Hospital	North Kansas City	Missouri
United States	Advocate Health and Hospitals Corporation	Oakbrook Terrace	Illinois
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	Oklahoma Heart Hospital South	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Advent Health Orlando	Orlando	Florida
United States	Orlando Regional Medical Center	Orlando	Florida
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Arizona Cardiovascular Research Center	Phoenix	Arizona
United States	Banner-University Medical Center Phoenix	Phoenix	Arizona
United States	Phoenix Cardiovascular Research Group	Phoenix	Arizona
United States	Allegheny General Hospital - ASRI	Pittsburgh	Pennsylvania
United States	Providence Heart and Vascular	Portland	Oregon
United States	Hudson Valley Cardiovascular Practice, P.C.	Poughkeepsie	New York
United States	Rhode Island Hospital	Providence	Rhode Island
United States	NC Heart and Vascular Research	Raleigh	North Carolina
United States	WakeMed Hospital	Raleigh	North Carolina
United States	Eisenhower Medical Center	Rancho Mirage	California
United States	Renown Regional Medical Center	Reno	Nevada
United States	Bon Secours Heart & Vascular Institute	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Rochester General Hospital	Rochester	New York
United States	St. Francis Hospital	Roslyn	New York
United States	Mercy Medical Group - Cardiology	Sacramento	California
United States	Sutter Medical Center, Sacramento	Sacramento	California
United States	St. Cloud Hospital	Saint Cloud	Minnesota
United States	Mercy Hospital St. Louis	Saint Louis	Missouri
United States	Methodist Healthcare System of San Antonio	San Antonio	Texas
United States	San Diego Cardiac Center	San Diego	California
United States	California Pacific Medical Center - Van Ness Campus	San Francisco	California
United States	Swedish Medical Center - Heart & Vascular	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	Advanced Cardiovascular Specialists	Shreveport	Louisiana
United States	Sanford USD Medical Center	Sioux Falls	South Dakota
United States	Providence Hospital	Southfield	Michigan
United States	Tampa General Hospital	Tampa	Florida
United States	University of Arizona	Tucson	Arizona
United States	Oklahoma Heart Institute at Utica	Tulsa	Oklahoma
United States	Ventura Cardiology Consultants	Ventura	California
United States	Lourdes Cardiology Services	Voorhees	New Jersey
United States	George Washington University Hospital	Washington	District of Columbia
United States	Waukesha Memorial Hospital	Waukesha	Wisconsin
United States	Aspirus Wausau Hospital	Wausau	Wisconsin
United States	Iowa Heart Center	West Des Moines	Iowa
United States	The Reading Hospital and Medical Center	West Reading	Pennsylvania
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas
United States	Winchester Medical Center	Winchester	Virginia
United States	University of Massachusetts	Worcester	Massachusetts
United States	Main Line Health Center/Lankenau Hospital	Wynnewood	Pennsylvania
United States	St. Elizabeth Health Center	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	(Randomized Arm) Cardiovascular mortality	The number of deaths with cardiovascular cause	12 months post-implantation
Other	(Randomized Arm) All-cause hospitalizations	The number of hospitalizations of any cause	12 months post-implantation
Other	(Randomized Arm) Frequency of subject PA pressure uploads	The frequency of subject uploads of PA pressure	12 months post-implantation
Other	(Randomized Arm) Frequency of clinician review of subject PA pressure uploads	The frequency of clinician review of subject uploads of PA pressure	12 months post-implantation
Other	(Randomized Arm) HF medication changes	The number of changes in HF medications	12 months post-implantation
Other	(Randomized Arm) PA pressure measurements	PA pressure measurements	Baseline through 12 months post-implantation
Other	(Randomized Arm) NT-proBNP (or BNP)	NT-proBNP (or BNP) measurements	Baseline, 6, and 12 months post-implantation
Other	(Randomized Arm) HFHs post- vs. pre-implantation	The number of HFHs at 12 months post-implantation compared to the num ber of HFHs in the 12 months prior to implantation	12 months post-implantation
Other	(Single Arm) EQ-5D-5L	Health status as assessed by the EQ-5D-5L Questionnaire	Baseline, 6, and 12 months post-implantation
Other	(Single Arm) KCCQ-12	Health status as assessed by the KCCQ-12	Baseline, 6, and 12 months post-implantation
Other	(Single Arm) 6MHW Test	6MHW Test Distance	Baseline, 6, and 12 months post-implantation
Other	(Single Arm) Cardiovascular mortality	The number of deaths of cardiovascular cause	12 months post-implantation
Other	(Single Arm) All-cause hospitalizations	The number of hospitalizations of any cause	12 months post-implantation
Other	(Single Arm) Frequency of subject PA pressure uploads	The frequency of subject uploads of PA pressure	12 months post-implantation
Other	(Single Arm) Frequency of clinician review of subject PA pressure uploads	The frequency of clinician review of subject uploads of PA pressure	12 months post-implantation
Other	(Single Arm) HF medication changes	The number of changes in HF medications	12 months post-implantation
Other	(Single Arm) PA pressure measurements	PA pressure measurements	Baseline through 12 months post-implantation
Other	(Single Arm) NT-proBNP (or BNP)	NT-proBNP (or BNP) measurements	Baseline, 6, and 12 months post-implantation
Primary	(Randomized Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality	The composite of: The number of recurrent HFHs; The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy; The number of deaths of any cause; added together with equal weighting into a total number of events	12 months post-implantation
Primary	(Single Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality	The composite outcome of: The number of recurrent HFHs; The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy; The number of deaths of any cause; added together with equal weighting into a total number of events	12 months post-implantation
Secondary	(Randomized Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits	The composite outcome of: The number of recurrent HFHs; The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy; added together with equal weighting into a total number of events	12 months post-implantation
Secondary	(Randomized Arm) EQ-5D-5L	Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire	Baseline, 6, and 12 months post-implantation
Secondary	(Randomized Arm) KCCQ-12	Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)	Baseline, 6, and 12 months post-implantation
Secondary	(Randomized Arm) 6MHW Test	Six Minute Hall Walk (6MHW) Test Distance	Baseline, 6, and 12 months post-implantation
Secondary	(Randomized Arm) HFHs	The number of recurrent HFHs	12 months post-implantation
Secondary	(Randomized Arm) Intravenous diuretic visits	The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy	12 months post-implantation
Secondary	(Randomized Arm) All-cause mortality	The number of deaths of any cause	12 months post-implantation
Secondary	(Randomized Arm) Safety: Freedom from DSRCs	Freedom from device/system related complications (DSRCs)	12 months post-implantation
Secondary	(Single Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits	The composite outcome of: The number of recurrent HFHs; The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy; added together with equal weighting into a total number of events	12 months post-implantation
Secondary	(Single Arm) HFHs post- vs. pre-implantation	The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation	12 months post-implantation
Secondary	(Single Arm) HFHs	The number of HFHs	12 months post-implantation
Secondary	(Single Arm) Intravenous diuretic visits	The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy	12 months post-implantation
Secondary	(Single Arm) All-cause mortality	The number of deaths of any cause	12 months post-implantation
Secondary	(Single Arm) Safety: Freedom from DSRCs	Freedom from DSRCs	12 months post-implantation