Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
21 participants
INTERVENTIONAL
2011-01-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intervention
Hydralazine/amlodipine
Patients will receive drug therapy aimed to reducing blood pressure - first line drug will be hydralazine up to 100mg/day; if systolic blood pressure reduces less than 20% from baseline and remains over 100mmHg patients will further receive amlodipine up to 10mg/day
Control
Placebo
Patients will receive placebo
Interventions
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Hydralazine/amlodipine
Patients will receive drug therapy aimed to reducing blood pressure - first line drug will be hydralazine up to 100mg/day; if systolic blood pressure reduces less than 20% from baseline and remains over 100mmHg patients will further receive amlodipine up to 10mg/day
Placebo
Patients will receive placebo
Eligibility Criteria
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Inclusion Criteria
* ejection fraction of 40% or less, as measured by transthoracic echocardiography
* optimal clinical treatment for chronic heart failure according to current international guidelines.
Exclusion Criteria
* rheumatic or degenerative valvular disease
* restrictive cardiomyopathy
* evidence of myocardial ischemia
* alcohol or drug use
* malignant neoplasm
* active infection
* surgical intervention in the 3 previous months
* lactation, childbearing or childbearing potential.
* pulmonary embolism in the 6 previous months
18 Years
ALL
No
Sponsors
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Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
University of Sao Paulo
OTHER
Responsible Party
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Edimar Alcides Bocchi
Heart Failure Team Directos
Principal Investigators
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Edimar A Bocchi, Prof.
Role: PRINCIPAL_INVESTIGATOR
Heart Institute (InCor) HC FMUSP
Locations
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Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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CNPq 474992/2009-8
Identifier Type: -
Identifier Source: org_study_id
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