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

Phase 3

• Conditions: Heart Failure Acute
• Interventions: Diagnostic Test: Lung Impedance Device; Drug: Anti-congestive treatment

• Registration Number: NCT04080388
• Lead Sponsor: Hillel Yaffe Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-28
• Status Verified: 2019-09
• Study Start: 2019-09
• Study First Submitted QC: 2019-09-04
• Last Update Submitted: 2019-09-04
• Study First Posted: 2019-09-06
• Last Update Posted: 2019-09-06
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Group	Lung Impedance Device	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.
Control Group	Lung Impedance Device	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.
Interventional Group	Anti-congestive treatment	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.

Primary Outcome Measures

Name	Time	Method
Prevention of heart failure re-admission	90 days	90-day re-admission rates will be compared between the two groups

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel