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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-7tmkv9 |
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Date of registration:
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11/12/2012 |
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Primary sponsor: |
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Public title:
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Italian Study on Sleep and Heart Failure
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Scientific title:
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Italian Multicenter Project Sleep and Heart Failure - PROMISES: Design Multicenter Sleep and Heart Failure |
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Date of first enrolment:
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01/08/2012 |
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Target sample size:
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60 |
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Recruitment status: |
recruiting |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-7tmkv9/ |
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Study type:
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Study design:
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A multicenter observational cohort study.
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Luís
Oliveira |
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Address:
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Av Francisco Matarazzo, 612 - Água Branca
05001-100
São Paulo
Brazil |
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Telephone:
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+55(11)3665-9894 |
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Email:
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oliveira.lvf@pq.cnpq.br |
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Affiliation:
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Universidade Nove de Julho - UNINOVE |
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Name:
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Luis Vicente
Oliveira |
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Address:
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Rua Vergueiro, 235/249 - Liberdade
01504-001
São Paulo
Brazil |
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Telephone:
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+55(11)3385-9000 |
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Email:
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oliveira.lvf@uninove.br |
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Affiliation:
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Universidade Nove de Julho - UNINOVE |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with heart failure who agree to participate in the study; both gender; age between 19 and 90 years; cognitive level sufficient to understand the procedures and follow the instructions; stable clinical conditions for at least four weeks and optimized medical therapy; assigned consent form."
Exclusion criteria: Individuals with HIV; renal failure with the calculation of filtered under 30ml/minutes; malignant neoplasm; abuse of alcohol and or drugs.
Age minimum:
19Y
Age maximum:
90Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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Heart failure, sleep respiratory disorders and quality of life.
I43.8
G47.3
I01.800
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Intervention(s)
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The objective of this study is to quantify the incidence of cardiovascular events in patients with chronic heart failure and their relation to sleep respiratory disorders. Will be invited to participate in this study 60 patients with heart failure recruited from the hypertension unit of Heart Institute - InCor, School of Medicine, University of Sao Paulo - USP in São Paulo. The protocol for the assesment of patients will be conducted in the period of august/2012 to june/2014, initially, 30 and 180 days after the first assessment of each patient. This protocol is composed of clinical evaluation, polysomnography, analysis of autonomic nervous activity through the analysis of heart rate variability, questionnaires of quality of life, and being conducted at the inclusion of the patient, 30 and 180 days after. The clinical evaluation, polysomnography examinations of heart rate variability and quality of life questionnaires will be made in all patients at the Sleep Laboratory of the Graduate Program Masters and PhD in Rehabilitation Sciences at Nove de Julho University - UNINOVE
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Primary Outcome(s)
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Expected to get the index and obstructive respiratory events during sleep or central, verified through the apnea/hypopnea per hour of sleep obtained by basal nocturnal polysomnography
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Secondary Outcome(s)
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Check the change in total sleep time, sleep latency, sleep stages, arousal index, abnormal sleep behavior evaluated by polysomnography nocturnal basal
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Check the level of the autonomic nervous activity sympathetic and parasympathetic verified through analysis of heart rate variability during sleep
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Measuring the neck circumference measured in centimeters, by means of tape, to check whether there is a relationship with the object of study
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Measuring the quality of life assessed by the quality of life questionnaire SF-36 (generic questionnaire, with concepts not specific to a certain age, disease or treatment group and allows for comparisons between different diseases and different treatments
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Realize that there is presence of excessive daytime sleepiness verified by Epworth Sleepiness Scale (This is a scale consisting of a series of key questions, which are widely used to see how sleep affects your daily life. You will confer as walking the likelihood of falling asleep in certain situations)
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To investigate the risk of obstructive sleep apnea verified by clinical questionnaire Berlin(screening instrument syndrome obstructive sleep apnea(OSA)in primary care)
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Secondary ID(s)
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01203912.1.0000.5511
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18204/2012
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Source(s) of Monetary Support
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Universidade Nove de Julho - UNINOVE - Brazil
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