Evaluation of Heart Failure Treatment Guided by NTproBNP vs Clinical Symptoms and Signs Alone - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00391846

Purpose

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

Condition	Intervention	Phase
Heart Failure Ventricular Dysfunction, Left	Drug: Captopril Drug: Enalapril Drug: Lisinopril Drug: Ramipril Drug: Trandolapril Drug: Bisoprolol Drug: Carvedilol Drug: Metoprolol succinate Drug: Candesartan Drug: Valsartan Drug: Eplerenone Drug: Spironolactone Drug: Diuretics Drug: HF treatment according to Swedish guidelines Procedure: Blood samples Procedure: KCCQ Questionnaire	Phase IV

MedlinePlus related topics: Heart Failure

Drug Information available for: Metoprolol Metoprolol fumarate Metoprolol succinate Metoprolol Tartrate Lisinopril Valsartan Succinic acid Candesartan cilexetil CV 11974 Ramipril Trandolapril Spironolactone Carvedilol Enalapril Enalapril maleate Enalaprilat Captopril Bisoprolol Bisoprolol fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomised, Single Blind, Multicentre, 9-Month, Phase IV Study, Comparing Treatment Guided by Clinical Symptoms and Signs and NT-proBNP vs Treatment Guided by Clinical Symptoms and Signs Alone, in Patients With HF and Left Ventricular Systolic Dysfunction

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary variable is a composite endpoint of days alive, days out of hospital and symptoms [ Time Frame: Assessed after 9 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of deaths [ Time Frame: Assessed after 9 months of treatment ] [ Designated as safety issue: Yes ]
Changes in NTproBNP over time amd related to NYHA class [ Time Frame: Assessed after 9 months of treatment ] [ Designated as safety issue: No ]
Changes in KCCQ (overall, symptom score subset, related to NTproBNP) [ Time Frame: Assessed after 9 months of treatment ] [ Designated as safety issue: No ]
Changes in HFstatus and vital signs [ Time Frame: Assessed after 9 months of treatment ] [ Designated as safety issue: No ]
Number of SAEs [ Time Frame: Assessed after 9 months of treatment ] [ Designated as safety issue: No ]
Number of DAEs [ Time Frame: Assessed after 9 months of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	250
Study Start Date:	October 2006
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female/male, over 18 years with previously verified HF with left ventricular systolic dysfunction.
NYHA class II-IV,
NTproBNP males>800 ng/L, females >1000 ng/L

Exclusion Criteria:

Planned CV hospitalisation, stroke or acute MI last 3 months,
Mitral/aortic stenosis,
Patients already receiving optimal HF treatment,
Severe reduction of kidney function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391846

Locations

Sweden
Research Site
UMEA, Sweden
Research Site
UPPSALA, Sweden
Research Site
VASTERAS, Sweden
Research Site
ALVESTA, Sweden
Research Site
ARVIKA, Sweden
Research Site
BJUV, Sweden
Research Site
BORENSBERG, Sweden
Research Site
BROMMA, Sweden
Research Site
DALBY, Sweden
Research Site
ESKILSTUNA, Sweden
Research Site
GAGNEF, Sweden
Research Site
G�TEBORG, Sweden
Research Site
HISINGS K�RRA, Sweden
Research Site
HUDDINGE, Sweden
Research Site
HUSKVARNA, Sweden
Research Site
J�NK�PING, Sweden
Research Site
KALMAR, Sweden
Research Site
KUNG�LV, Sweden
Research Site
LERUM, Sweden
Research Site
LESSEBO, Sweden
Research Site
V�XJ�, Sweden
Research Site
LILLA EDET, Sweden
Research Site
LINK�PING, Sweden
Research Site
LUDVIKA, Sweden
Research Site
LYCKEBY, Sweden
Research Site
MALM�, Sweden
Research Site
MOHEDA, Sweden
Research Site
MOTALA, Sweden
Research Site
�REBRO, Sweden
Research Site
�STERSUND, Sweden
Research Site
SKAN�R, Sweden
Research Site
S�DER�KRA, Sweden
Research Site
STENUNGSUND, Sweden
Research Site
STOCKSUND, Sweden
Research Site
TIMR�, Sweden
Research Site
UDDEVALLA, Sweden
Research Site
ULRICEHAMN, Sweden
Research Site
V�STER�S, Sweden
Research Site
V�STERVIK, Sweden
Research Site
LIDK�PING, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	AstraZeneca Sweden Medical Director, MD	AstraZeneca
Principal Investigator:	Hans Persson, MD, PhD	Danderyd Hospital, Sweden
Study Director:	Bjorn Eriksson, MD	AstraZeneca

More Information

Responsible Party:	Medical Department, AstraZeneca ( Björn Ericsson, MD, Director Medical Affairs, AZ Sweden )
Study ID Numbers:	D2452L00010, EUDRACT No. 2006-001259-36, SIGNAL HF
Study First Received:	October 19, 2006
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00391846
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Heart Failure
Ventricular Dysfunction
NTproBNP

Study placed in the following topic categories:

Captopril
Ventricular Dysfunction
Heart Failure
Heart Diseases
Lisinopril
Angiotensin II
Metoprolol
Ramipril
Spironolactone
Candesartan cilexetil
Signs and Symptoms

Bisoprolol
Eplerenone
Enalapril
Trandolapril
Enalaprilat
Metoprolol succinate
Candesartan
Ventricular Dysfunction, Left
Valsartan
Carvedilol

Additional relevant MeSH terms:

Neurotransmitter Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Cardiotonic Agents
Hormone Antagonists
Physiological Effects of Drugs
Diuretics
Hormones, Hormone Substitutes, and Hormone Antagonists
Therapeutic Uses
Adrenergic beta-Antagonists
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Anti-Arrhythmia Agents

Sympatholytics
Enzyme Inhibitors
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Protective Agents
Pharmacologic Actions
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Aldosterone Antagonists
Autonomic Agents
Natriuretic Agents
Adrenergic Antagonists
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009