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

NCT04080388 | Unknown Phase 3 DMC

• 1 other identifier: HYMC-0073-19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Interventional Group

ACTIVE COMPARATOR

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; Drug: Anti-congestive treatment

Interventions

Lung Impedance Device 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.

Control Group; Interventional Group

Anti-congestive treatment DRUG

Continuation of in-hospital anti-congestive treatment

Also known as: Diuretic therapy

Interventional Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute Heart Failure Patients Prior to Hospital Discharge

You may not qualify if:

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

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Study Officials

• Karina Zilber, MD

  Hillel Yaffe Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Kleiner Shochat, MD, PhD

CONTACT

972-50-6246926; shochat1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 6, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)