ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

OSASEAT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

obese

obstructive sleep apnea

epicardial fat

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Not applicable

Comparator / control treatment

control group will be obese patients without obstructive sleep apnea syndrome

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Epicardial adipose tissue (EAT) is the primary outcome. EAT is evaluated by the mean of thickness measurements obtained during echocardiography examination

Timepoint [1]

At inclusion

Secondary outcome [1]

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]

at inclusion

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

France

State/province [1]

Martinique

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Antilles

Address [1]

Université des Antilles Campus de Schoelcher, Martinique

Country [1]

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]

University

Name [1]

Université Antilles

Address [1]

Campus de Fouillole 97110 Pointe-à-Pitre, Guadeloupe,

Country [1]

France

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

CNIL

Ethics committee address [1]

Ethics committee country [1]

France

Date submitted for ethics approval [1]

15/05/2016

Approval date [1]

15/07/2016

Ethics approval number [1]

Summary

Brief summary

Considering that obese patients with obstructive sleep apnea syndrome (OSA) and increases epicardial adipose tissue (EAT) thickness display sympathetic over activation at baseline conditions, we sought to investigate the effect of this autonomic dysfunction on HRR. Whereas several studies have demonstrated attenuated heart rate recovery (HRR) in obese patients with either OSA or EAT accumulation, whether overlap of both conditions may further impair HRR has not been previously reported. The main objective of our study was to test whether post-exercise HRR in obese patients would be independently associated with OSA condition and EAT increase.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof REMI NEVIERE

Address

CHU Martinique Department of Cardiology , F-97200 Fort de France,

Country

France

Phone

+33596553524

Fax

+33596553525

remi.neviere@chu-martinique.fr

Contact person for public queries

Name

REMI NEVIERE

Address

CHU Martinique Department of Cardiology , F-97200 Fort de France,

Country

France

Phone

+33596553524

Fax

+33596553525

remi.neviere@chu-martinique.fr

Contact person for scientific queries

Name

REMI NEVIERE

Address

CHU Martinique Department of Cardiology , F-97200 Fort de France,

Country

France

Phone

+33596553524

Fax

+33596553525

remi.neviere@chu-martinique.fr

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

Source	Title	Year of Publication	DOI
Embase	Epicardial fat accumulation is an independent marker of impaired heart rate recovery in obese patients with obstructive sleep apnea.	2019	https://dx.doi.org/10.1007/s00392-019-01454-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically