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Status unknownNCT01315223Updated Jul 21, 2016

Outpatient Lung Impedance-Guided Preventive Therapy in Patients With Chronic Heart Failure (CHF)

A Phase 3 interventional study of Lung impedence-guided treatment in Chronic Congestive Heart Failure, sponsored by Hillel Yaffe Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-21.

Sponsored by Hillel Yaffe Medical Center · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Chronic Congestive Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 300 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Hillel Yaffe Medical Center is the lead sponsor of 301 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients suffering from CHF, NYHA II-IV class
  • LV lower than 35% to LV lower than 45%

Exclusion criteria

Exclusion Criteria:

  • Patients with additional disease with life-expectancy of less than 2 years
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • No intervention
    Conventional treatment CHF patients

    One hundred and fifty patients with CHF will be treated according to current guidelines (conventional treatment).

  • Experimental
    Lung impedence-guided treatment

    Other: Lung impedence-guided treatment

Interventions

  • OtherLung impedence-guided treatment

    One hundred fifty patients with CHF will be treated according to common practice and values of lung impedance

06

What researchers measure

Primary outcomes

  1. Reduction of hospitalization for acute heart failure

    Time frame: Five years

Secondary outcomes

  1. Improved clinical outcome for CHF patients

    Time frame: Five years

07

Study locations

1 of 1 sites recruiting
  • Hillel Yaffe Medical Center
    Hadera, 38100, Israel
    • Michael Shochat, MD · Contact · shochat1@yahoo.com · 972-4-630-4484
    • Michael Shochat, MD, PhD · Principal investigator
    • Avraham Shotan, MD · Sub investigator
    • Mark Kazatsker, MD · Sub investigator
    • Yaniv Levy, MD · Sub investigator
    • Simcha Meisel, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 34674821 ↗
  • 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. doi: 10.1016/j.cardfail.2017.05.004. PubMed 27058408 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01315223
Lead sponsor
Hillel Yaffe Medical Center
Responsible party
Sponsor
First posted
Mar 15, 2011
Start date
Mar 2011
Primary completion
Jun 2018 (estimated)
Completion
Jun 2018 (estimated)
Last update
Jul 21, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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