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Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)

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ClinicalTrials.gov Identifier: NCT03387813
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

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.

Condition or disease Intervention/treatment Phase
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 Device: CardioMEMS™ HF System Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Hemodynamic-GUIDEd Management of Heart Failure
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Randomized Arm - Treatment Group

Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System.

All subjects will receive a CardioMEMS™ HF System.

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.
Other Names:
  • CardioMEMS
  • CardioMEMS PA Sensor
  • CardioMEMS HF System

Experimental: Randomized Arm - Control Group

Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System.

All subjects will receive a CardioMEMS™ HF System.

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.
Other Names:
  • CardioMEMS
  • CardioMEMS PA Sensor
  • CardioMEMS HF System

Experimental: Single Arm

Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System.

All subjects will receive a CardioMEMS™ HF System.

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.
Other Names:
  • CardioMEMS
  • CardioMEMS PA Sensor
  • CardioMEMS HF System




Primary Outcome Measures :
  1. (Randomized Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality [ Time Frame: 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


  2. (Single Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality [ Time Frame: 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 :
  1. (Randomized Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits [ Time Frame: 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


  2. (Randomized Arm) EQ-5D-5L [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire

  3. (Randomized Arm) KCCQ-12 [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

  4. (Randomized Arm) 6MHW Test [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    Six Minute Hall Walk (6MHW) Test Distance

  5. (Randomized Arm) HFHs [ Time Frame: 12 months post-implantation ]
    The number of recurrent HFHs

  6. (Randomized Arm) Intravenous diuretic visits [ Time Frame: 12 months post-implantation ]
    The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

  7. (Randomized Arm) All-cause mortality [ Time Frame: 12 months post-implantation ]
    The number of deaths of any cause

  8. (Randomized Arm) Safety: Freedom from DSRCs [ Time Frame: 12 months post-implantation ]
    Freedom from device/system related complications (DSRCs)

  9. (Single Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits [ Time Frame: 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


  10. (Single Arm) HFHs post- vs. pre-implantation [ Time Frame: 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

  11. (Single Arm) HFHs [ Time Frame: 12 months post-implantation ]
    The number of HFHs

  12. (Single Arm) Intravenous diuretic visits [ Time Frame: 12 months post-implantation ]
    The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

  13. (Single Arm) All-cause mortality [ Time Frame: 12 months post-implantation ]
    The number of deaths of any cause

  14. (Single Arm) Safety: Freedom from DSRCs [ Time Frame: 12 months post-implantation ]
    Freedom from DSRCs


Other Outcome Measures:
  1. (Randomized Arm) Cardiovascular mortality [ Time Frame: 12 months post-implantation ]
    The number of deaths with cardiovascular cause

  2. (Randomized Arm) All-cause hospitalizations [ Time Frame: 12 months post-implantation ]
    The number of hospitalizations of any cause

  3. (Randomized Arm) Frequency of subject PA pressure uploads [ Time Frame: 12 months post-implantation ]
    The frequency of subject uploads of PA pressure

  4. (Randomized Arm) Frequency of clinician review of subject PA pressure uploads [ Time Frame: 12 months post-implantation ]
    The frequency of clinician review of subject uploads of PA pressure

  5. (Randomized Arm) HF medication changes [ Time Frame: 12 months post-implantation ]
    The number of changes in HF medications

  6. (Randomized Arm) PA pressure measurements [ Time Frame: Baseline through 12 months post-implantation ]
    PA pressure measurements

  7. (Randomized Arm) NT-proBNP (or BNP) [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    NT-proBNP (or BNP) measurements

  8. (Randomized Arm) HFHs post- vs. pre-implantation [ Time Frame: 12 months post-implantation ]
    The number of HFHs at 12 months post-implantation compared to the num ber of HFHs in the 12 months prior to implantation

  9. (Single Arm) EQ-5D-5L [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    Health status as assessed by the EQ-5D-5L Questionnaire

  10. (Single Arm) KCCQ-12 [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    Health status as assessed by the KCCQ-12

  11. (Single Arm) 6MHW Test [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    6MHW Test Distance

  12. (Single Arm) Cardiovascular mortality [ Time Frame: 12 months post-implantation ]
    The number of deaths of cardiovascular cause

  13. (Single Arm) All-cause hospitalizations [ Time Frame: 12 months post-implantation ]
    The number of hospitalizations of any cause

  14. (Single Arm) Frequency of subject PA pressure uploads [ Time Frame: 12 months post-implantation ]
    The frequency of subject uploads of PA pressure

  15. (Single Arm) Frequency of clinician review of subject PA pressure uploads [ Time Frame: 12 months post-implantation ]
    The frequency of clinician review of subject uploads of PA pressure

  16. (Single Arm) HF medication changes [ Time Frame: 12 months post-implantation ]
    The number of changes in HF medications

  17. (Single Arm) PA pressure measurements [ Time Frame: Baseline through 12 months post-implantation ]
    PA pressure measurements

  18. (Single Arm) NT-proBNP (or BNP) [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    NT-proBNP (or BNP) measurements



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387813


Contacts
Contact: Rebecca Apruzzese 818-493-4210 rebecca.apruzzese@abbott.com
Contact: Nessa Johnson, PhD 651-756-3738 nessa.johnson@abbott.com

  Show 45 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Director: Poornima Sood, MD, MBA Abbott

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT03387813     History of Changes
Other Study ID Numbers: CIP-10170
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by St. Jude Medical:
Heart Failure
Hemodynamic Monitoring
CardioMEMS
Pulmonary Artery Pressure

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases