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

July 20, 2016 updated by: Hillel Yaffe Medical Center

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Recruiting
        • Hillel Yaffe Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Shochat, MD, PhD
        • Sub-Investigator:
          • Avraham Shotan, MD
        • Sub-Investigator:
          • Mark Kazatsker, MD
        • Sub-Investigator:
          • Yaniv Levy, MD
        • Sub-Investigator:
          • Simcha Meisel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
One hundred fifty patients with CHF will be treated according to common practice and values of lung impedance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of hospitalization for acute heart failure
Time Frame: Five years
Five years

Secondary Outcome Measures

Outcome Measure
Time Frame
Improved clinical outcome for CHF patients
Time Frame: Five years
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

March 13, 2011

First Submitted That Met QC Criteria

March 13, 2011

First Posted (Estimate)

March 15, 2011

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0010-11-HYMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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