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

Hillel Yaffe Medical Center

Status and phase: Unknown; Phase 3

Conditions: Heart Failure Acute

Treatments: Diagnostic Test: Lung Impedance Device; Drug: Anti-congestive treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04080388

HYMC-0073-19

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Lung Impedance Device

Interventional Group

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Lung Impedance Device

Drug: Anti-congestive treatment