N/A
N=2,358
Hemodynamic-GUIDEd Management of Heart Failure
Heart Failure · Heart Failure, Systolic · Heart Failure, Diastolic · Heart Failure NYHA Class II · Heart Failure NYHA Class III
Bottom Line
View on ClinicalTrials.gov: NCT03387813 ↗Enrolled (actual)
2,358
Serious AEs
58.3%
Results posted
Aug 2025
Primary outcome: Primary: (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality — 0.563; 0.640 events per patient-year — p=0.1624
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CardioMEMS™ HF System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality |
0.563; 0.640 | 0.1624 |
| PRIMARY (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis] |
0.553; 0.682; 0.597; 0.536 | — |
| PRIMARY (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis] |
0.710; 0.864; 0.508; 0.539 | — |
| PRIMARY (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis] |
0.563; 0.633; 0.558; 0.619 | — |
| PRIMARY (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality |
0.394; 0.771 | — |
| PRIMARY (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis] |
0.263; 0.861; 0.418; 0.744 | — |
| PRIMARY (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis] |
0.582; 1.853; 0.391; 0.698 | — |
| PRIMARY (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis] |
0.381; 0.746; 0.377; 0.737 | — |
| SECONDARY (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits |
0.474; 0.557 | 0.0958 |
| SECONDARY (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis) |
0.450; 0.595; 0.539; 0.455 | — |
| SECONDARY (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis) |
0.529; 0.729; 0.465; 0.488 | — |
| SECONDARY (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis) |
0.474; 0.551; 0.472; 0.545 | — |
| SECONDARY (Randomized Arm) HFHs |
0.410; 0.497 | 0.0644 |
| SECONDARY (Randomized Arm) HFHs [Follow-up Based COVID-19 Sensitivity Analysis] |
0.380; 0.525; 0.490; 0.414 | — |
| SECONDARY (Randomized Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis] |
0.467; 0.666; 0.399; 0.428 | — |
| SECONDARY (Randomized Arm) HFHs [Event Based COVID-19 Sensitivity Analysis] |
0.411; 0.490; 0.409; 0.484 | — |
| SECONDARY (Randomized Arm) Intravenous Diuretic Visits |
0.065; 0.063 | 0.8867 |
| SECONDARY (Randomized Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis] |
0.074; 0.073; 0.048; 0.041 | — |
| SECONDARY (Randomized Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis] |
0.067; 0.071; 0.067; 0.060 | — |
| SECONDARY (Randomized Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis] |
0.065; 0.063; 0.065; 0.063 | — |
| SECONDARY (Randomized Arm) All-cause Mortality |
0.094; 0.086 | 0.7119 |
| SECONDARY (Randomized Arm) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis] |
0.110; 0.088; 0.067; 0.085 | — |
| SECONDARY (Randomized Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis] |
0.200; 0.161; 0.044; 0.053 | — |
| SECONDARY (Randomized Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis] |
0.094; 0.086; 0.090; 0.079 | — |
| SECONDARY (Randomized Arm) KCCQ-12 |
7.36; 6.01; 4.77; 4.14 | 0.3484 |
| SECONDARY (Randomized Arm) KCCQ-12 (Subject Based COVID-19 Sensitivity Analysis) |
54.8; 56.4; 65.1; 63.6; 62.0; 62.9 | — |
| SECONDARY (Randomized Arm) EQ-5D-5L |
3.18; 3.20; 1.02; 2.50 | 0.9901 |
| SECONDARY (Randomized Arm) EQ-5D-5L (Subject Based COVID-19 Sensitivity Analysis) |
66.5; 67.3; 71.7; 71.2; 68.3; 71.5 | — |
| SECONDARY (Randomized Arm) 6MHW Test |
-1.13; 3.01; -13.02; -10.09 | 0.5741 |
| SECONDARY (Randomized Arm) 6MHW Test (Subject Based COVID-19 Sensitivity Analysis) |
227; 243.8; 239.3; 260.8; 230.4; 245.1 | — |
| SECONDARY (Randomized Arm) Safety: Freedom From DSRCs |
494; 498 | — |
| SECONDARY (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits |
0.288; 0.630 | — |
| SECONDARY (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis] |
0.211; 0.677; 0.303; 0.616 | — |
| SECONDARY (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis] |
0.436; 1.520; 0.286; 0.583 | — |
| SECONDARY (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis] |
0.282; 0.624; 0.277; 0.617 | — |
| SECONDARY (Single Arm) Intravenous Diuretic Visits |
0.027; 0.077; 0.123 | <0.0001 sig |
| SECONDARY (Single Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis] |
0.055; 0.064; 0.199; 0.024; 0.088; 0.114 | — |
| SECONDARY (Single Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis] |
0.213; 0.082; 0.422; 0.021; 0.080; 0.101 | — |
| SECONDARY (Single Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis] |
0.027; 0.077; 0.123; 0.027; 0.075; 0.119 | — |
| SECONDARY (Single Arm) HFHs |
0.263; 0.557; 0.797 | <0.0001 sig |
| SECONDARY (Single Arm) HFHs [Follow-Up Based COVID-19 Sensitivity Analysis] |
0.214; 0.804; 1.211; 0.280; 0.529; 0.732 | — |
| SECONDARY (Single Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis] |
0.175; 1.132; 1.660; 0.269; 0.510; 0.719 | — |
| SECONDARY (Single Arm) HFHs [Event Based COVID-19 Sensitivity Analysis] |
0.257; 0.552; 0.790; 0.252; 0.545; 0.749 | — |
| SECONDARY (Single Arm) All-cause Mortality |
0.113; 0.146; 0.243 | 0.0001 sig |
| SECONDARY (Single Arm) All-cause Mortality [Follow-Up Based COVID-19 Sensitivity Analysis] |
0.050; 0.182; 0.272; 0.123; 0.135; 0.233 | — |
| SECONDARY (Single Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis] |
0.147; 0.384; 0.583; 0.113; 0.120; 0.202 | — |
| SECONDARY (Single Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis] |
0.105; 0.125; 0.231; 0.105; 0.123; 0.227 | — |
| SECONDARY (Single Arm) Safety: Freedom From DSRCs |
451; 548; 342 | — |
| SECONDARY (Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP Only Group] |
0; 0.265 | — |
| SECONDARY (Single Arm) HFHs Post- vs. Pre-implantation [Previous HF Hospitalization Only Group] |
1.170; 0.540 | <0.0001 sig |
| SECONDARY (Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP and Previous HF Hospitalization Group] |
1.380; 0.874 | <0.001 sig |
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.
Eligibility Criteria
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 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) 15) at implant right heart catheterization (RHC), a history of non-compliance, or any condition that would preclude CardioMEMS™ PA Sensor implantation
Data sourced from ClinicalTrials.gov (NCT03387813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.