Evaluation of NT PRO BNP Guided Therapy on Hospitalizatio... | NCT00469001

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

NCT00469001

Sponsor

Hillel Yaffe Medical Center

Status

Completed

Last Update Posted

Sep 14, 2010Estimated

Enrollment

108Actual

Phase

Not provided

Conditions

Chronic Heart Failure

Interventions

Treatment according NT Pro BNP level

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Jan 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

May 2, 2007

First Submission Date that Met QC Criteria

May 2, 2007

First Posted Date

May 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2010

Last Update Posted Date

Sep 14, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Name	Type	Description	Arm Group Labels	Other Names
Treatment according NT Pro BNP level	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

All conditions with life expectancy less than 2 years.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Shochat, MD, PhD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

Type	Date	Date Unknown
Release	Mar 15, 2017
Reset	Apr 24, 2017

Submission Tracking

Estimated Results First Submitted Date

Mar 15, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 15, 2017			Apr 24, 2017