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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04080388
Other study ID # HYMC-0073-19
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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