Hemodynamic-GUIDEd Management of Heart Failure

Not Applicable

Completed

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

Registration Number: NCT03387813

Lead Sponsor: Abbott Medical Devices

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2358

Inclusion Criteria

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.
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:
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
≥ 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

Exclusion Criteria

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:
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
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality	12 months post-implantation (395 days after implant date)	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
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]	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).	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.
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]	12 Months Post Implantation	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.
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]	12 Months Post-Implantation	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.
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality	12 months post-implantation (395 days after implant date)	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
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]	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).	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
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]	12 Months Post Implantation	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
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]	12 Months Post Implantation	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

Secondary Outcome Measures

Name	Time	Method
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits	12 months post-implantation	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
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis)	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).	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
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis)	12 Months Post Implantation	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
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis)	12 Months Post Implantation	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
(Randomized Arm) HFHs	12 months post-implantation	The number of recurrent HFHs
(Randomized Arm) HFHs [Follow-up Based COVID-19 Sensitivity Analysis]	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).	The number of recurrent HFHs
(Randomized Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis]	12 Months Post-Implantation	The number of recurrent HFHs
(Randomized Arm) HFHs [Event Based COVID-19 Sensitivity Analysis]	12 Months Post Implantation	The number of recurrent HFHs
(Randomized Arm) Intravenous Diuretic Visits	12 months post-implantation	The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
(Randomized Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]	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).	The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
(Randomized Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]	12 Months Post Implantation	The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
(Randomized Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]	12 Months Post-Implantation	The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
(Randomized Arm) All-cause Mortality	12 months post-implantation	The number of deaths of any cause
(Randomized Arm) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]	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).	The number of deaths of any cause
(Randomized Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]	12 Months Post-Implantation	The number of deaths of any cause
(Randomized Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]	12 Months Post-Implantation	The number of deaths of any cause
(Randomized Arm) KCCQ-12	Baseline, 6, and 12 months post-implantation	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.
(Randomized Arm) KCCQ-12 (Subject Based COVID-19 Sensitivity Analysis)	Baseline, 6, and 12 months post-implantation	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.
(Randomized Arm) EQ-5D-5L	Baseline, 6, and 12 months post-implantation	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.
(Randomized Arm) EQ-5D-5L (Subject Based COVID-19 Sensitivity Analysis)	Baseline, 6, and 12 months post-implantation	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.
(Randomized Arm) 6MHW Test	Baseline, 6, and 12 months post-implantation	Six Minute Hall Walk (6MHW) Test Distance
(Randomized Arm) 6MHW Test (Subject Based COVID-19 Sensitivity Analysis)	Baseline, 6, and 12 months post-implantation	Six Minute Hall Walk (6MHW) Test Distance
(Randomized Arm) Safety: Freedom From DSRCs	12 months post-implantation	Freedom from device/system related complications (DSRCs)
(Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits	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
(Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]	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).	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
(Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]	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
(Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]	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
(Single Arm) Intravenous Diuretic Visits	12 months post-implantation	The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy
(Single Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]	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).	The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy
(Single Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]	12 months post-implantation	The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy
(Single Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]	12 Months Post Implantation	The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy
(Single Arm) HFHs	12 months post-implantation	The number of HFHs
(Single Arm) HFHs [Follow-Up Based COVID-19 Sensitivity Analysis]	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).	The number of heart failure hospitalizations (HFHs)
(Single Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis]	12 Months Post Implantation	The number of heart failure hospitalizations (HFHs)
(Single Arm) HFHs [Event Based COVID-19 Sensitivity Analysis]	12 Months Post Implantation	The number of heart failure hospitalizations (HFHs)
(Single Arm) All-cause Mortality	12 months post-implantation	The number of deaths of any cause
(Single Arm) All-cause Mortality [Follow-Up Based COVID-19 Sensitivity Analysis]	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).	The number of deaths of any cause
(Single Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]	12 Months Post Implantation	The number of deaths of any cause
(Single Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]	12 Months Post Implantation	The number of deaths of any cause
(Single Arm) Safety: Freedom From DSRCs	12 months post-implantation	Proportion of subjects with freedom from device/system related complications (DSRCs)
(Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP Only Group]	12 months post-implantation vs 12 months pre-implantation	The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation
(Single Arm) HFHs Post- vs. Pre-implantation [Previous HF Hospitalization Only Group]	12 months post-implantation vs 12 months pre-implantation	The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation
(Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP and Previous HF Hospitalization Group]	12 months post-implantation vs 12 months pre-implantation	The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation

Trial Locations

Locations (129): Banner-University Medical Center Phoenix
🇺🇸
Phoenix, Arizona, United States
Arizona Cardiovascular Research Center
🇺🇸
Phoenix, Arizona, United States
Phoenix Cardiovascular Research Group
🇺🇸
Phoenix, Arizona, United States
University of Arizona
🇺🇸
Tucson, Arizona, United States
Washington Regional Medical Center
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Fayetteville, Arkansas, United States
Baptist Health Medical Center
🇺🇸
Little Rock, Arkansas, United States
Arkansas Heart Hospital
🇺🇸
Little Rock, Arkansas, United States
John Muir Medical Center
🇺🇸
Concord, California, United States
Adventist Health St. Helena
🇺🇸
Deer Park, California, United States
Scripps Health
🇺🇸
La Jolla, California, United States
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Banner-University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States