Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000467235
Ethics application status
Approved
Date submitted
9/12/2008
Date registered
16/06/2009
Date last updated
16/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of autonomic control of heart rate in older male patients with chronic obstructive pulmonary disease or chronic heart failure at rest and during sinusal respiratory arrhythmia maneuver
Scientific title
Evaluation of autonomic control of heart rate in older male patients with chronic obstructive pulmonary disease or chronic heart failure at rest and during sinusal respiratory arrhythmia maneuver
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autonomic control of heart rate 237035 0
Condition category
Condition code
Cardiovascular 237358 237358 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Twenty-eight male volunteers were sub-divided in three groups: ten presented chronic obstructive pulmonary disease (COPD – 69+/-9 years); nine presented chronic heart failure (CHF - 62+/-8 years) and; nine were healthy with 64+/-5 year-old (control). During all experimental protocol, the subjects were monitored at the chest-manubrio lead (MC5) to record the heart rate (HR) beat-to-beat. The ECG and HR were obtained from a one-channel heart monitor (TC 500, ECAFIX, Sao Paulo, SP, Brazil) and processed using an analog-digital converter Lab. PC+ (National Instruments, Co.,Austin, TX, USA), which represents an interface between the heart monitor and a Pentium III microcomputer. The signals were recorded in real time after analog to digital conversion on a beat-to-beat basis using specific software. The three groups’ the electrocardiography signal were obtained on the following conditions: 1) supine position for 15 min; and 2) supine position during the respiratory sinusal arrhythmia (M-RSA)for 4 min. The data were analyzed by the time and the frequency domain. Regarding the M-RSA indexes, the expiratory/inspiratory ratio (E/I) and the inspiratory/expiratory difference (IE difference) were calculated. All evaluations were performed on the same day.
Intervention code [1] 3823 0
Not applicable
Comparator / control treatment
There was a control group where all volunteers were healthy for to compare the cardiac autonomic control. The control volunteers underwent the same evaluated of patients. Additionally, there were two patients groups: 1) volunteers with chronic obstructive pulmonary disease, and 2) volunteers with chronic heart failure.
Control group
Active

Outcomes
Primary outcome [1] 238166 0
The respiratory sinusal arrhythmia maneuver is able to characterize the changes of autonomic activity in the control of heart rate.
Timepoint [1] 238166 0
All evaluated were performed at the same day.
Secondary outcome [1] 242446 0
The heart rate variability at rest is able to characterize the changes of autonomic activity in the control of heart rate
Timepoint [1] 242446 0
All evaluated were performed at the same day

Eligibility
Key inclusion criteria
Inclusion criteria for COPD patients were: forced expiratory volume in one second (FEV1) / forced vital capacity (FVC) ratio < 0.7 and FEV1 < 60% of predicted; clinical stability for at least 3 months prior to the study; nonsmokers; no participation in a regular physically active program in for the last 6 months; and presentation of dyspnea under low and medium physical effort. Inclusion criteria for CHF patients were: previous history of stable symptomatic heart failure due to left ventricular systolic dysfunction, documented in at least six months (left ventricular ejection fraction < 45 % predict); no recent hospitalizations and no history of pulmonary disease or angina. Subjects in the control group were free of chronic pulmonary, cardiovascular, immune, and metabolic disease.
Minimum age
55 Years
Maximum age
78 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
unstable patients, female, patients without clinical exams

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 1464 0
Brazil
State/province [1] 1464 0
Country [2] 1465 0
Brazil
State/province [2] 1465 0

Funding & Sponsors
Funding source category [1] 237159 0
Government body
Name [1] 237159 0
Conselho Nacional de Desenvolvimento Tecnologico e Cientifico
Country [1] 237159 0
Brazil
Primary sponsor type
University
Name
Federal University of Sao Carlos
Address
Rodovia Washington Luis, km 235 - SP-310
Sao Carlos - Sao Paulo - Brasil
Zip-code: 13565-905
Country
Brazil
Secondary sponsor category [1] 4649 0
None
Name [1] 4649 0
Address [1] 4649 0
Country [1] 4649 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239250 0
Ethics Committee of Federal University of Sao Carlos
Ethics committee address [1] 239250 0
Ethics committee country [1] 239250 0
Brazil
Date submitted for ethics approval [1] 239250 0
Approval date [1] 239250 0
Ethics approval number [1] 239250 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35028 0
Address 35028 0
Country 35028 0
Phone 35028 0
Fax 35028 0
Email 35028 0
Contact person for public queries
Name 12375 0
Audrey Borghi Silva
Address 12375 0
Rodovia Washington Luis, km 235 - SP-310
Sao Carlos - Sao Paulo - Brasil
Country 12375 0
Brazil
Phone 12375 0
(+55 16) 3351-8705
Fax 12375 0
Email 12375 0
[email protected]
Contact person for scientific queries
Name 3303 0
Audrey Borghi Silva
Address 3303 0
Rodovia Washington Luis, km 235 - SP-310
Sao Carlos - Sao Paulo - Brasil
Country 3303 0
Brazil
Phone 3303 0
(+55 16) 3351-8705
Fax 3303 0
Email 3303 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAutonomic control of heart rate in patients with chronic cardiorespiratory disease and in healthy participants at rest and during a respiratory sinus arrhythmia maneuver. [Portuguese]2010
N.B. These documents automatically identified may not have been verified by the study sponsor.