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.

Study Timeline

• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-22
• Study First Posted: 2018-01-02
• Study Start: 2018-03-15
• Status Verified: 2022-08
• Primary Completion: 2023-05-17
• Study Completion: 2023-05-17
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2358

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

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	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
(Single Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality	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

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 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
(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
(Randomized Arm) 6MHW Test	Baseline, 6, and 12 months post-implantation	Six Minute Hall Walk (6MHW) Test Distance
(Randomized Arm) Intravenous diuretic visits	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) Safety: Freedom from DSRCs	12 months post-implantation	Freedom from device/system related complications (DSRCs)
(Single Arm) HFHs	12 months post-implantation	The number of HFHs
(Single Arm) HFHs post- vs. pre-implantation	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
(Single Arm) Intravenous diuretic visits	12 months post-implantation	The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
(Single Arm) All-cause mortality	12 months post-implantation	The number of deaths of any cause
(Single Arm) Safety: Freedom from DSRCs	12 months post-implantation	Freedom from DSRCs
(Randomized Arm) HFHs	12 months post-implantation	The number of recurrent HFHs
(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
(Randomized Arm) KCCQ-12	Baseline, 6, and 12 months post-implantation	Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

Trial Locations

Locations (134)

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

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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