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

About MANAGE-HF1,2

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.

 

 

Safe Integration into Clinical Practice

 

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.

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 rate
  • NTproBNP levels significantly decreased from median 1316 pg/mL at baseline to 743 pg/mL at 12 months (p<0.001)
  • 1.76 alert case/patient-year shown in MANAGE-HF Phase I was consistent with expectations based on alert case rate previously reported in MultiSENSE3
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).
 

 

Phase II: Enrolling Early 2022

 
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.
 

 
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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.

3. 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.

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