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Electrophysiology / HeartLogic™ Heart Failure Diagnostic / Clinical Data / MANAGE-HF Study

About MANAGE-HF1,2,3

Overview

The MANAGE-HF study is a multi-center, global, prospective, open-label, multi-phase trial. Phase I enrolled 200 patients implanted with a CRT-D or ICD enabled with the HeartLogic™ Heart Failure Diagnostic.

Goals

The goal of Phase I was to evaluate and optimize the integration of HeartLogic into clinical practice for the treatment of heart failure (HF). Phase II of the MANAGE-HF study will evaluate the efficacy of augmented HF treatment in remotely monitored patients with HeartLogic alerts turned on compared to patients with alerts turned off.

Conclusions

In Phase I, HeartLogic was integrated into clinical care safely and early treatment augmentation was associated with more rapid recovery of the HeartLogic index compared to patients with no change in treatment following an alert.

Read the Manuscript
Infographic showing MANAGE-HF Phase I outcomes, including more rapid recovery of HeartLogic Index and lower NTproBNP levels.
 
Watch Adrian Hernandez, MD, MHS highlight the results of Phase I.
Hernandez video
 
 

Safe Integration into Clinical Practice

 
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Phase I of the MANAGE-HF study demonstrated the HeartLogic multisensor algorithm was safely integrated into clinical practice. In 333 patient-years of follow-up:2

  • 74% of alert cases prompted augmentation of HF medications relative to pre-alert dose
  • HF medications were augmented relative to pre-alert dose within 7 days of 54% of weekly alerts
  • 89% of HF medications augmented within seven days of weekly alerts were diuretics
  • Only five serious adverse events* (SAEs) in relation to alert-prompted medication changes were reported, which translates to 0.015 SAEs per patient-year

The low number of SAEs in the study suggests that alert-prompted medication changes did not result in overly aggressive heart failure management practices.

*SAEs above were classified as abnormal laboratory values, renal insufficiency/failure, dizziness, or syncope in response to an alert-prompted medication change.2

 
 

Early HF Treatment Augmentation

 

Early decongestive treatment in response to an alert was associated with more rapid recovery of the HeartLogic index compared to patients with no change in treatment following an alert. In addition, HeartLogic was associated with lower hospitalization rates and N-terminal pro b-type natriuretic peptide (NTproBNP) levels.2

MANAGE-HF: Phase I Study Highlights

  • HeartLogic was associated with a 67% reduction in heart failure hospitalizations compared to pre-study, 12-month HF hospitalization rate2
  • NTproBNP levels significantly decreased from median 1316 pg/mL at baseline to 743 pg/mL at 12 months (p<0.001)3
  • 1.76 alert case/patient-year shown in MANAGE-HF Phase I3 was consistent with expectations based on alert case rate previously reported in MultiSENSE4
Icon of three patients standing together.
200 PATIENTS

Enrolled in Phase I

Icon of a clock with the number “333” to illustrate 333 patient-years of follow-up.
333 PATIENT-YEARS

Of Follow-Up

Icon of a circle with 67% in the middle.
67% REDUCTION

In HF Hospitalizations Associated with HeartLogic**

**Compared with pre-study hospitalization rate (12 months).
 
Watch Carolyn Lam, MD, PhD discuss the MANAGE-HF Alert Management Guide including how investigators suggest responding to HeartLogic alerts.
Watch Carolyn Lam, MD, PhD discuss the MANAGE-HF Alert Management Guide including how investigators suggest responding to HeartLogic alerts.
 
Watch full MANAGE-HF webinar
 
 

Phase II: Enrolling 2023

 
Phase II of the MANAGE-HF study will enroll patients implanted with CRT-D or ICD devices enabled with HeartLogic. Phase II will evaluate the efficacy of augmented HF treatment in remotely monitored patients with HeartLogic alerts turned on compared to patients who have remote monitoring with HeartLogic alerts turned off.
See Enrollment Criteria
Infographic showing that Phase II will enroll remotely monitored ICD/CRT-D patients with HeartLogic alerts turned on or off.
 
 
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MultiSENSE Study
Explore the data showing that HeartLogic provides a sensitive and timely predictor of impending HF events.4
Real-World Evidence
See how HeartLogic consistently detected HF events in real-world analyses of nearly 500 patients in four studies.
 

LATITUDE NXT™ Remote Patient Management System: Indications, Safety and Warnings

RESONATE™ ICD: Indications, Safety and Warnings

RESONATE™ CRT-D: Indications, Safety and Warnings

References

1. Multiple Cardiac Sensors for the Management of Heart Failure (MANAGE-HF).
https://clinicaltrials.gov/ct2/show/NCT03237858.

2. Hernandez AF, Albert N, Allen L, et al. Multiple cardiac sensors for management of heart failure (MANAGE-HF) Phase I results. Abstract presented at: European Society of Heart Failure 2021 World Congress on Acute Heart Failure: June 29-July 1, 2021. Virtual. https://onlinelibrary.wiley.com/doi/epdf/10.1002/ejhf.2297 (Pg 159)

3. Hernandez AF, Albert N, Allen L, et al. Multiple cardiac sensors for management of Heart Failure (MANAGE-HF) – Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart Failure. JCF. 2022 April (in press). https://doi.org/10.1016/j.cardfail.2022.03.349

4. Boehmer JP, Hariharan R, Devecchi FG, et al. A multisensor algorithm predicts heart failure events in patients with implanted devices: results from the MultiSENSE study. JACC Heart Fail. 2017 Mar;5(3):216-225. doi: 10.1016/j.jchf.2016.12.011. https://www.jacc.org/doi/full/10.1016/j.jchf.2016.12.011

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