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

NCT ID: NCT04080388

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2021-09-30

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.

Conditions

Heart Failure Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Lung Impedance Device

Intervention Type: DIAGNOSTIC_TEST

The non-invasive lung impedance device enables assessment of the level of pulmonary congestion and can be an indication for additional anti-congestive treatment.

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.

Group Type: ACTIVE_COMPARATOR

Lung Impedance Device

Intervention Type: DIAGNOSTIC_TEST

The non-invasive lung impedance device enables assessment of the level of pulmonary congestion and can be an indication for additional anti-congestive treatment.

Anti-congestive treatment

Intervention Type: DRUG

Continuation of in-hospital anti-congestive treatment

Interventions

Lung Impedance Device

The non-invasive lung impedance device enables assessment of the level of pulmonary congestion and can be an indication for additional anti-congestive treatment.

Intervention Type: DIAGNOSTIC_TEST

Anti-congestive treatment

Continuation of in-hospital anti-congestive treatment

Intervention Type: DRUG

Other Intervention Names

Diuretic therapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karina Zilber, MD

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

Hillel Yaffe Medical Center

Hadera, , Israel

Countries

Israel

Central Contacts

Michael Kleiner Shochat, MD, PhD

Role: CONTACT

shochat1@gmail.com

972-50-6246926

Facility Contacts

Michael Kleiner Shochat, MD, PhD

Role: primary

972-50-6246926

Other Identifiers

HYMC-0073-19

Identifier Type: -

Identifier Source: org_study_id