Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone

NCT ID: NCT00391846

Last Updated: 2012-06-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-01-31

Brief Summary

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The purpose is to study if HF treatment guided by NTproBNP in addition to clinical symptoms and signs is more effective than treatment guided by clinical symptoms and signs alone in patients with HF and left ventricular systolic dysfunction

Detailed Description

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Conditions

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Heart Failure Ventricular Dysfunction, Left

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Guided by NT-proBNP

Treatment guided by clinical symptoms and signs + NTproBNP

Group Type OTHER

Captopril

Intervention Type DRUG

Enalapril

Intervention Type DRUG

Lisinopril

Intervention Type DRUG

Ramipril

Intervention Type DRUG

Trandolapril

Intervention Type DRUG

Bisoprolol

Intervention Type DRUG

Carvedilol

Intervention Type DRUG

Metoprolol succinate

Intervention Type DRUG

Candesartan

Intervention Type DRUG

Valsartan

Intervention Type DRUG

Eplerenone

Intervention Type DRUG

Spironolactone

Intervention Type DRUG

Diuretics

Intervention Type DRUG

HF treatment according to Swedish guidelines

Intervention Type DRUG

Blood samples

Intervention Type PROCEDURE

The Kansas City Cardiomyopathy Questionnaire (KCCQ)

Intervention Type PROCEDURE

Not Guided by NT-proBNP

Treatment guided by clinical symptoms and signs

Group Type OTHER

Captopril

Intervention Type DRUG

Enalapril

Intervention Type DRUG

Lisinopril

Intervention Type DRUG

Ramipril

Intervention Type DRUG

Trandolapril

Intervention Type DRUG

Bisoprolol

Intervention Type DRUG

Carvedilol

Intervention Type DRUG

Metoprolol succinate

Intervention Type DRUG

Candesartan

Intervention Type DRUG

Valsartan

Intervention Type DRUG

Eplerenone

Intervention Type DRUG

Spironolactone

Intervention Type DRUG

Diuretics

Intervention Type DRUG

HF treatment according to Swedish guidelines

Intervention Type DRUG

Blood samples

Intervention Type PROCEDURE

The Kansas City Cardiomyopathy Questionnaire (KCCQ)

Intervention Type PROCEDURE

Interventions

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Captopril

Intervention Type DRUG

Enalapril

Intervention Type DRUG

Lisinopril

Intervention Type DRUG

Ramipril

Intervention Type DRUG

Trandolapril

Intervention Type DRUG

Bisoprolol

Intervention Type DRUG

Carvedilol

Intervention Type DRUG

Metoprolol succinate

Intervention Type DRUG

Candesartan

Intervention Type DRUG

Valsartan

Intervention Type DRUG

Eplerenone

Intervention Type DRUG

Spironolactone

Intervention Type DRUG

Diuretics

Intervention Type DRUG

HF treatment according to Swedish guidelines

Intervention Type DRUG

Blood samples

Intervention Type PROCEDURE

The Kansas City Cardiomyopathy Questionnaire (KCCQ)

Intervention Type PROCEDURE

Other Intervention Names

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Atacand

Eligibility Criteria

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Inclusion Criteria

* Female/male, over 18 years with previously verified HF with left ventricular systolic dysfunction.
* New York Heart Association(NYHA) class II-IV,
* NTproBNP males\>800 ng/L, females \>1000 ng/L

Exclusion Criteria

* Planned CV hospitalisation, stroke or acute myocardial infarction (MI) last 3 months,
* Mitral/aortic stenosis,
* Patients already receiving optimal HF treatment,
* Severe reduction of kidney function
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca Sweden Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Hans Persson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Danderyd Hospital, Sweden

Bjorn Eriksson, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Alvesta, , Sweden

Site Status

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Arvika, , Sweden

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Bjuv, , Sweden

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Borensberg, , Sweden

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Bromma, , Sweden

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Dalby, , Sweden

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Eskilstuna, , Sweden

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Gagnef, , Sweden

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Gothenburg, , Sweden

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Hisings Kärra, , Sweden

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Huddinge, , Sweden

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Huskvarna, , Sweden

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Jönköping, , Sweden

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Kalmar, , Sweden

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Kungälv, , Sweden

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Lerum, , Sweden

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Lessebo, , Sweden

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Lidköping, , Sweden

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Lilla Edet, , Sweden

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Linköping, , Sweden

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Ludvika, , Sweden

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Lyckeby, , Sweden

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Malmo, , Sweden

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Moheda, , Sweden

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Motala, , Sweden

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Örebro, , Sweden

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Östersund, , Sweden

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Skanör, , Sweden

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Söderåkra, , Sweden

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Stenungsund, , Sweden

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Stocksund, , Sweden

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Timrå, , Sweden

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Uddevalla, , Sweden

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Ulricehamn, , Sweden

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Umeå, , Sweden

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Uppsala, , Sweden

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Vaxjo, , Sweden

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Västerås, , Sweden

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Västervik, , Sweden

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Countries

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Sweden

Other Identifiers

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EUDRACT No. 2006-001259-36

Identifier Type: -

Identifier Source: secondary_id

SIGNAL HF

Identifier Type: -

Identifier Source: secondary_id

D2452L00010

Identifier Type: -

Identifier Source: org_study_id

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