Back to resultsOutpatient Lung Impedance-Guided Preventive Therapy in Patients With Chronic Heart Failure (CHF)
Primary Purpose
Chronic Congestive Heart Failure
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Lung impedence-guided treatment
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Congestive Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Patients suffering from CHF, NYHA II-IV class
- LV lower than 35% to LV lower than 45%
Exclusion Criteria:
- Patients with additional disease with life-expectancy of less than 2 years
Sites / Locations
- Hillel Yaffe Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Conventional treatment CHF patients
Lung impedence-guided treatment
Arm Description
One hundred and fifty patients with CHF will be treated according to current guidelines (conventional treatment).
Outcomes
Primary Outcome Measures
Reduction of hospitalization for acute heart failure
Secondary Outcome Measures
Improved clinical outcome for CHF patients
Full Information
NCT ID
NCT01315223
First Posted
March 13, 2011
Last Updated
July 20, 2016
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01315223
Brief Title
Outpatient Lung Impedance-Guided Preventive Therapy in Patients With Chronic Heart Failure (CHF)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients suffering from Chronic Heart Failure (CHF) are hospitalized for acute heart failure (AHF) several times a year. Currently, we have no method for prediction of future developments of AHF. In our center we have investigated the monitoring of lung impedence as a predictor for future deterioration. It was found that a decrease in lung impedence of more than 15% from normal value predicts AHF development with sensitivity of 98%. In this study we try to prove the hypothesis that preventive treatment according to lung impedence value may prevent future hospitalizations for AHF and improve clinical outcome.
Patients recruited by year:
2011 - 50; 2012 - 25; 2013 - 35; 2014 - 30; 2015 - 50; 2016 - 5
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Congestive Heart Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional treatment CHF patients
Arm Type
No Intervention
Arm Description
One hundred and fifty patients with CHF will be treated according to current guidelines (conventional treatment).
Arm Title
Lung impedence-guided treatment
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Lung impedence-guided treatment
Intervention Description
One hundred fifty patients with CHF will be treated according to common practice and values of lung impedance
Primary Outcome Measure Information:
Title
Reduction of hospitalization for acute heart failure
Time Frame
Five years
Secondary Outcome Measure Information:
Title
Improved clinical outcome for CHF patients
Time Frame
Five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients suffering from CHF, NYHA II-IV class
LV lower than 35% to LV lower than 45%
Exclusion Criteria:
Patients with additional disease with life-expectancy of less than 2 years
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Shochat, MD
Phone
972-4-630-4484
Email
shochat1@yahoo.com
First Name & Middle Initial & Last Name & Degree
Michael Shochat, MD, PhD
First Name & Middle Initial & Last Name & Degree
Avraham Shotan, MD
First Name & Middle Initial & Last Name & Degree
Mark Kazatsker, MD
First Name & Middle Initial & Last Name & Degree
Yaniv Levy, MD
First Name & Middle Initial & Last Name & Degree
Simcha Meisel, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
34674821
Citation
Kleiner Shochat M, Fudim M, Kapustin D, Kazatsker M, Kleiner I, Weinstein JM, Panjrath G, Rozen G, Roguin A, Meisel SR. Early Impedance-Guided Intervention Improves Long-Term Outcome in Patients With Heart Failure. J Am Coll Cardiol. 2021 Oct 26;78(17):1751-1752. doi: 10.1016/j.jacc.2021.08.036. No abstract available.
Results Reference
derived
PubMed Identifier
27058408
Citation
Shochat MK, Shotan A, Blondheim DS, Kazatsker M, Dahan I, Asif A, Rozenman Y, Kleiner I, Weinstein JM, Frimerman A, Vasilenko L, Meisel SR. Non-Invasive Lung IMPEDANCE-Guided Preemptive Treatment in Chronic Heart Failure Patients: A Randomized Controlled Trial (IMPEDANCE-HF Trial). J Card Fail. 2016 Sep;22(9):713-22. doi: 10.1016/j.cardfail.2016.03.015. Epub 2016 Apr 4. Erratum In: J Card Fail. 2017 Jun;23 (6):512-513.
Results Reference
derived
Learn more about this trial
Outpatient Lung Impedance-Guided Preventive Therapy in Patients With Chronic Heart Failure (CHF)
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