Hemodynamic-GUIDEd Management of Heart Failure

Abbott Medical Devices2,358 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

2,358

Conditions

Heart Failure Heart Failure, Systolic Heart Failure, Diastolic

Interventions

CardioMEMS™ HF SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Fayetteville, Arkansas, United States

Outcomes

Primary Outcomes

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

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

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

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

Time frame: 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).

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

Time frame: 12 Months Post Implantation

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

Time frame: 12 Months Post-Implantation

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

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

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

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

Time frame: 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).

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

Time frame: 12 Months Post Implantation

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

Time frame: 12 Months Post Implantation

Secondary Outcomes

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

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

Time frame: 12 months post-implantation

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

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

Time frame: 12 Months Post Implantation

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

Time frame: 12 Months Post Implantation

(Randomized Arm) HFHs

The number of recurrent HFHs

Time frame: 12 months post-implantation

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

The number of recurrent HFHs

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

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

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

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

Time frame: 12 Months Post Implantation

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

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

Time frame: 12 Months Post-Implantation

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

The number of deaths of any cause

(Randomized Arm) KCCQ-12

Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. Change from baseline KCCQ-12 scores were evaluated at 6 and 12-month visits.

Time frame: Baseline, 6, and 12 months post-implantation

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

Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. Descriptive statistics of KCCQ-12 scores at baseline, 6 and 12-month visits were reported.

Time frame: Baseline, 6, and 12 months post-implantation

(Randomized Arm) EQ-5D-5L

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

Time frame: Baseline, 6, and 12 months post-implantation

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

Time frame: Baseline, 6, and 12 months post-implantation

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

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

Time frame: 12 months post-implantation

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

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

Time frame: 12 Months Post Implantation

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

Time frame: 12 Months Post Implantation

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

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

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

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

Time frame: 12 months post-implantation

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

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

Time frame: 12 Months Post Implantation

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

The number of heart failure hospitalizations (HFHs)

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

The number of deaths of any cause

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

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

Time frame: 12 months post-implantation vs 12 months pre-implantation

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

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

Time frame: 12 months post-implantation vs 12 months pre-implantation

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

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

Time frame: 12 months post-implantation vs 12 months pre-implantation