Open Actively Recruiting

Hemodynamic-GUIDEd Management of Heart Failure

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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:
    • Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).
    • Subjects with LVEF > 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL).
    • 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:
    • Continuous or chronic use of scheduled intermittent inotropic therapy for HF and an INTERMACS level of ≤ 4, OR
    • 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

Join this Trial

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Study Stats
Protocol No.
18-001272
Category
Cardiology
Contact
Sandra Rodriguez
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03387813
For detailed technical eligibility, visit ClinicalTrials.gov.