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Clinical Trials/NCT04080388
NCT04080388
Unknown
Phase 3

How to Prevent Heart Failure Readmission by Using Lung Impedance Device (HOPE-HF Study)

Hillel Yaffe Medical Center1 site in 1 country200 target enrollmentSeptember 2019

Overview

Phase
Phase 3
Intervention
Lung Impedance Device
Conditions
Heart Failure Acute
Sponsor
Hillel Yaffe Medical Center
Enrollment
200
Locations
1
Primary Endpoint
Prevention of heart failure re-admission
Last Updated
6 years ago

Overview

Brief Summary

The readmission of Heart Failure (HF) patients for exacerbation HF within 30-day is unmet goal. The mail reason for readmission is excessive accumulation of fluid in patient's lung. According our data (1,2) around 40% of HF patient have excessive lung fluid at discharge from HF hospitalization ("unacceptable" residual congestion on discharge). In other words, around 40% patients are discharged from HF hospitalization prematurely when they are not ready to be discharged. Only 60% of HF patients are discharged from HF admission with "acceptable" level of residual pulmonary congestion (2). There are some techniques to assess "readiness" of HF patients for discharge. Pulmonary congestion (lung fluid accumulation) may be assessed non-invasively by measurement Brain Natriuretic Peptide (BNP), (3,4), by lung ultrasound (LUS), (5-7) and by Lung Impedance (LI) method (1,2). LUS is operator depended technique. LI and BNP techniques are most reliable methods (2) and easy to use.

Registry
clinicaltrials.gov
Start Date
September 2019
End Date
September 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Acute Heart Failure Patients Prior to Hospital Discharge

Exclusion Criteria

  • No Cardiac Resynchronization Device Implanted During Current Hospitalization
  • Estimated glomerular filtrating rate (GFR) less than 30 ml/min

Arms & Interventions

Control Group

Patients prior to discharge for acute heart failure admission will be examined with a lung impedance device for their suitability for discharge according to their level of pulmonary congestion. Only patients who are unsuitable for discharge according to the lung impedance assessment will be enrolled in the study. The control group (half of the patients) will be discharged without additional intervention.

Intervention: Lung Impedance Device

Interventional Group

Patients prior to discharge for acute heart failure admission will be examined with a lung impedance device for their suitability for discharge according to their level of pulmonary congestion. Only patients who are unsuitable for discharge according to the lung impedance assessment will be enrolled in the study. The interventional group (half of the patients) will continue anti-congestive treatment while hospitalized until achieving a suitable level of decongestion.

Intervention: Lung Impedance Device

Interventional Group

Patients prior to discharge for acute heart failure admission will be examined with a lung impedance device for their suitability for discharge according to their level of pulmonary congestion. Only patients who are unsuitable for discharge according to the lung impedance assessment will be enrolled in the study. The interventional group (half of the patients) will continue anti-congestive treatment while hospitalized until achieving a suitable level of decongestion.

Intervention: Anti-congestive treatment

Outcomes

Primary Outcomes

Prevention of heart failure re-admission

Time Frame: 90 days

90-day re-admission rates will be compared between the two groups

Study Sites (1)

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