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

Heart Failure Acute Clinical Trial

— HOPE-HF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04080388
• Other study ID #: HYMC-0073-19
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 2019
• Est. completion date: September 2021

Study information

• Verified date: September 2019
• Source: Hillel Yaffe Medical Center
• Contact: Michael Kleiner Shochat, MD, PhD
• Phone: 972-50-6246926
• Email: shochat1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure Acute

Intervention

Diagnostic Test:
• 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.

Drug:
• Anti-congestive treatment
Continuation of in-hospital anti-congestive treatment

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of heart failure re-admission	30-day re-admission rates will be compared between the two groups	30 days
Primary	Prevention of heart failure re-admission	90-day re-admission rates will be compared between the two groups	90 days