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

Primary Purpose

Heart Failure Acute

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Lung Impedance Device
Anti-congestive treatment
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control Group

Interventional Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Prevention of heart failure re-admission
30-day re-admission rates will be compared between the two groups
Prevention of heart failure re-admission
90-day re-admission rates will be compared between the two groups

Secondary Outcome Measures

Full Information

First Posted
August 28, 2019
Last Updated
September 4, 2019
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04080388
Brief Title
How to Prevent Heart Failure Readmission by Using Lung Impedance Device (HOPE-HF Study)
Acronym
HOPE-HF
Official Title
How to Prevent Heart Failure Readmission by Using Lung Impedance Device (HOPE-HF Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure Acute

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm 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.
Arm Title
Interventional Group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Lung Impedance Device
Intervention Description
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
Drug
Intervention Name(s)
Anti-congestive treatment
Other Intervention Name(s)
Diuretic therapy
Intervention Description
Continuation of in-hospital anti-congestive treatment
Primary Outcome Measure Information:
Title
Prevention of heart failure re-admission
Description
30-day re-admission rates will be compared between the two groups
Time Frame
30 days
Title
Prevention of heart failure re-admission
Description
90-day re-admission rates will be compared between the two groups
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Kleiner Shochat, MD, PhD
Phone
972-50-6246926
Email
shochat1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karina Zilber, MD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Kleiner Shochat, MD, PhD
Phone
972-50-6246926

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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