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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure Acute

Intervention / Treatment
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* Diagnostic Test: Lung Impedance Device
* Drug: Anti-congestive treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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. | Diagnostic Test: Lung Impedance Device<br>* The non-invasive lung impedance device enables assessment of the level of pulmonary congestion and can be an indication for additional anti-congestive treatment.<br>|
| Active Comparator: Interventional Group<br>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. | Diagnostic Test: Lung Impedance Device<br>* The non-invasive lung impedance device enables assessment of the level of pulmonary congestion and can be an indication for additional anti-congestive treatment.<br>Drug: Anti-congestive treatment<br>* Continuation of in-hospital anti-congestive treatment<br>* Other names: Diuretic therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of heart failure re-admission | 30-day re-admission rates will be compared between the two groups | 30 days | 
| Prevention of heart failure re-admission | 90-day re-admission rates will be compared between the two groups | 90 days |