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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00391846 |
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 |
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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 |
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 |
Estimated Enrollment: | 250 |
Study Start Date: | October 2006 |
Study Completion Date: | January 2009 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
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UMEA, Sweden | |
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UPPSALA, Sweden | |
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VASTERAS, Sweden | |
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ALVESTA, Sweden | |
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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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G�TEBORG, Sweden | |
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HISINGS K�RRA, Sweden | |
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HUDDINGE, Sweden | |
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HUSKVARNA, Sweden | |
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J�NK�PING, Sweden | |
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KALMAR, Sweden | |
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KUNG�LV, Sweden | |
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LERUM, Sweden | |
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LESSEBO, Sweden | |
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V�XJ�, Sweden | |
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LILLA EDET, Sweden | |
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LINK�PING, Sweden | |
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LUDVIKA, Sweden | |
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LYCKEBY, Sweden | |
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MALM�, Sweden | |
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MOHEDA, Sweden | |
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MOTALA, Sweden | |
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�REBRO, Sweden | |
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�STERSUND, Sweden | |
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SKAN�R, Sweden | |
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S�DER�KRA, Sweden | |
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STENUNGSUND, Sweden | |
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STOCKSUND, Sweden | |
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TIMR�, Sweden | |
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UDDEVALLA, Sweden | |
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ULRICEHAMN, Sweden | |
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V�STER�S, Sweden | |
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V�STERVIK, Sweden | |
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LIDK�PING, Sweden |
Study Director: | AstraZeneca Sweden Medical Director, MD | AstraZeneca |
Principal Investigator: | Hans Persson, MD, PhD | Danderyd Hospital, Sweden |
Study Director: | Bjorn Eriksson, MD | AstraZeneca |
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: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00391846 History of Changes |
Health Authority: | Sweden: Medical Products Agency |
Heart Failure Ventricular Dysfunction NTproBNP |
Ventricular Dysfunction Vasodilator Agents Neurotransmitter Agents Adrenergic Agents Hormone Antagonists Diuretics Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Ramipril Candesartan cilexetil Signs and Symptoms Enalapril Angiotensin-Converting Enzyme Inhibitors Ventricular Dysfunction, Left Adrenergic beta-Antagonists |
Anti-Arrhythmia Agents Valsartan Carvedilol Captopril Heart Failure Heart Diseases Lisinopril Adrenergic alpha-Antagonists Cardiovascular Agents Angiotensin II Antihypertensive Agents Metoprolol Protease Inhibitors Spironolactone Angiotensin II Type 1 Receptor Blockers |
Ventricular Dysfunction Vasodilator Agents Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Hormone Antagonists Diuretics Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Signs and Symptoms Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Ventricular Dysfunction, Left Adrenergic beta-Antagonists |
Cardiovascular Diseases Anti-Arrhythmia Agents Carvedilol Sympatholytics Heart Failure Heart Diseases Lisinopril Enzyme Inhibitors Adrenergic alpha-Antagonists Cardiovascular Agents Antihypertensive Agents Metoprolol Protective Agents Pharmacologic Actions Protease Inhibitors |