Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001487202
Ethics application status
Approved
Date submitted
23/08/2018
Date registered
5/09/2018
Date last updated
5/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Abnormal heart rate recovery after exercise and excessive accumulation of fat around the heart in obese patients with sleep breathing disorders
Scientific title
Blunted heart rate recovery and epicardial fat accumulation in obese patients with obstructive sleep apnea
Secondary ID [1] 295882 0
None
Universal Trial Number (UTN)
Trial acronym
OSASEAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obese 309347 0
obstructive sleep apnea 309348 0
epicardial fat 309349 0
Condition category
Condition code
Cardiovascular 308212 308212 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Days
Description of intervention(s) / exposure
Obese patients BMI >30 will be enrolled to perform polysomnography test, cardio-pulmonary exercise testing and echocardiography. Relationship between heart rate recovery, epicardial fat thickness and obstructive sleep apnea will be studied.
Cardiopulmonary exercise testing was performed according to standardized procedures using an electromagnetic braked cycle ergometer. by cardiologists experienced in exercise physiology.
Exercise protocol involved an initial 3 minutes of rest, followed by unloaded cycling for 2 minutes of unload cycling with a progressively increment every minute (10 watt/minute) until exhaustion at a pedaling frequency of 60-65 rpm. Subjects were continuously monitored using 12-lead ECG (Case, GE Healthcare, France). Blood pressure assessed were recorded every 2-minutes. Subjects respired through an oro-nasal mask (Hans Rudolf 7450 SeriesV2™ Mask, CareFusion, France). Breath-by-breath cardiopulmonary data (PowerCube-Ergo, Ganshorn Medizin Electronic GmbH, Niederlauer, Germany) were measured at rest, warm up and incremental exercise testing. Before each test, oxygen (O2) and carbon dioxide (CO2) analyzers and flow mass sensor were calibrated using available precision gas mixture and a 3-L syringe, respectively. Minute ventilation (VE), oxygen uptake (VO2), carbon dioxide output (VCO2) were recorded as concurrent 10-s moving averages, as was determined ventilation anaerobic threshold by the V-slope method. Ventilatory reserve was calculated as (MVV – peak VE) / MVV * 100, where MVV is maximal voluntary ventilation estimated as FEV1 multiplied by 35. Peak values were averaged over the last 30 s of exercise. Patient effort was considered to be maximal if two of the following occurred: predicted maximal work is achieved, predicted maximal heart rate (HR) is achieved, VE/VO2 > 45 and RER > 1.10, as recommended by the ATS/ACCP. At peak exercise, subjects assessed Borg-perceived exertion ratings for both respiratory and leg discomfort. During the study period, mean values between qualified replicate tests performed weekly on control subjects were 3.1 ± 4.2 %, 3.4 ± 3.2 %, 2.1 ± 2.2 %, for peak VO2, VCO2 and VE, respectively. Peak oxygen pulse (O2 pulse) was calculated and was expressed in mL per beat and as percentage of predicted value by dividing the predicted peak VO2 by predicted peak HR. VE/VCO2 slope was calculated off-line as a linear regression function using 10-s averaged values and excluding the non-linear part of the relationship after the respiratory compensation point (where non-linear rise in V’E occurred relative to VCO2 in the presence of decrease of end-tidal pressure of CO2). The percentage of HR reserve used at peak exercise referred to [(HRstage-HRrest) / (220-age in years-HRrest)] * 100, where HR is heart rate. Heart rate recovery was defined as the change in heart rate from peak exercise to 1 minute (HRR-1) and 3 minutes (HRR-3) later.
Intervention code [1] 312213 0
Not applicable
Comparator / control treatment
control group will be obese patients without obstructive sleep apnea syndrome
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307183 0
Epicardial adipose tissue (EAT) is the primary outcome. EAT is evaluated by the mean of thickness measurements obtained during echocardiography examination
Timepoint [1] 307183 0
At inclusion
Secondary outcome [1] 351023 0
Heart rate is measured during recovery, one and three minutes following maximal exercise.
Subjects were continuously monitored using 12-lead ECG (Case, GE Healthcare, France) during exercise testing and recovery. Heart rate were measured from ECG tracings.
Timepoint [1] 351023 0
at inclusion
Secondary outcome [2] 351024 0
obstructive sleep apnea is evalaution during polysomnography evaluation and its severity is characterized by apnea hyponea index (AHI) and oxygen desaturatio index (ODI).
Timepoint [2] 351024 0
at inclusion

Eligibility
Key inclusion criteria
obese BMI > 30
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
macrovascular sequellea of metabolic syndrome, such as hypertension, heart failure, coronary artery disease, renal failure

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
group comparison and logistic regression

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2016
Date of last participant enrolment
Anticipated
Actual
1/08/2018
Date of last data collection
Anticipated
Actual
1/08/2018
Sample size
Target
35
Accrual to date
Final
37
Recruitment outside Australia
Country [1] 20796 0
France
State/province [1] 20796 0
Martinique

Funding & Sponsors
Funding source category [1] 300480 0
University
Name [1] 300480 0
University of Antilles
Country [1] 300480 0
France
Primary sponsor type
Hospital
Name
CHU Martinique
Address
CHU Martinique, CS 90632 Fort de France, F-97200, France
Country
France
Secondary sponsor category [1] 299951 0
University
Name [1] 299951 0
Université Antilles
Address [1] 299951 0
Campus de Fouillole 97110 Pointe-à-Pitre, Guadeloupe,
Country [1] 299951 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301281 0
CNIL
Ethics committee address [1] 301281 0
Ethics committee country [1] 301281 0
France
Date submitted for ethics approval [1] 301281 0
15/05/2016
Approval date [1] 301281 0
15/07/2016
Ethics approval number [1] 301281 0

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

Contacts
Principal investigator
Name 86474 0
Prof REMI NEVIERE
Address 86474 0
CHU Martinique Department of Cardiology , F-97200 Fort de France,
Country 86474 0
France
Phone 86474 0
+33596553524
Fax 86474 0
+33596553525
Email 86474 0
[email protected]
Contact person for public queries
Name 86475 0
REMI NEVIERE
Address 86475 0
CHU Martinique Department of Cardiology , F-97200 Fort de France,
Country 86475 0
France
Phone 86475 0
+33596553524
Fax 86475 0
+33596553525
Email 86475 0
[email protected]
Contact person for scientific queries
Name 86476 0
REMI NEVIERE
Address 86476 0
CHU Martinique Department of Cardiology , F-97200 Fort de France,
Country 86476 0
France
Phone 86476 0
+33596553524
Fax 86476 0
+33596553525
Email 86476 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
EmbaseEpicardial fat accumulation is an independent marker of impaired heart rate recovery in obese patients with obstructive sleep apnea.2019https://dx.doi.org/10.1007/s00392-019-01454-6
N.B. These documents automatically identified may not have been verified by the study sponsor.