Evaluation of NT PRO BNP Guided Therapy on Hospitalization Rate and Mortality in Patients With Chronic HF NYHA II-IY

September 12, 2010 updated by: Hillel Yaffe Medical Center

Phase 1 Study of Using BNP as Guided Parameter in Treatment HF

To use continuous measurement of NT Pro BNP level as guide in therapy patients with CHF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Group of 100 patients with CHF, NYHA II-IY will be followed for 1 years in outpatient clinic of our hospital for hospitalization, death, 6 min walking protocol, number of decompensation as a primary end point. 50 patients will be treated according usual practice in outpatient clinics and in 50 patients will be additionally used level of NT Pro BNP as additional parameter.If level NT Pro BNP will be goes down will not be changes in treatment regiment. If level of NT Pro BNP will be increased treatment will be intensified.At the end of 1 year follow up we will compare the result of two strategies.

Study Type

Observational

Enrollment (Actual)

108

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
        • Hillel Yaffe Medical Center

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

Sampling Method

Probability Sample

Study Population

Patients with chronic heart failure. Half of the patients were treated by common medical practice for patients with heart failure. The other half were treated according to BNP values and common medical practice.

Description

Inclusion Criteria:

  • Patient older 18 y.old with CHF NYHA II-IY.

Exclusion Criteria:

  • All conditions with life expectancy 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

Collaborators and Investigators

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

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Michael Shochat, MD, PhD, Hillel Yaffe Medical Center

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

June 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

May 2, 2007

First Submitted That Met QC Criteria

May 2, 2007

First Posted (Estimate)

May 3, 2007

Study Record Updates

Last Update Posted (Estimate)

September 14, 2010

Last Update Submitted That Met QC Criteria

September 12, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00001

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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