Hemodynamic-GUIDEd Management of Heart Failure (NCT03387813) | Clinical Trial Compass
CompletedNot Applicable
Hemodynamic-GUIDEd Management of Heart Failure
United States2,358 participantsStarted 2018-03-15
Plain-language summary
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMSâ„¢ 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.
Who can participate
Age range18 Years
SexALL
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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:
✓. 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:
✓. 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
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)
What they're measuring
1
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality
Timeframe: 12 months post-implantation (395 days after implant date)
2
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]
Timeframe: 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).
3
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]
Timeframe: 12 Months Post Implantation
4
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]
Timeframe: 12 Months Post-Implantation
5
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality
Timeframe: 12 months post-implantation (395 days after implant date)
6
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]
Timeframe: 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).