Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001673134
Ethics application status
Approved
Date submitted
24/08/2019
Date registered
29/11/2019
Date last updated
29/11/2019
Date data sharing statement initially provided
29/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Abnormal heart rate rise in a population of Afro-Caribbean patients with cardiac amyloid disease
Scientific title
Chronotropic response to exercise and heart rate recovery in afro-caribbean patients with mutant transthyretin amyloid cardiomyopathy
Secondary ID [1] 299112 0
None
Universal Trial Number (UTN)
U1111-1239-1982
Trial acronym
AMYLORATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiac amyloidosis 314161 0
heart disease: cardiomyopathy 314162 0
Condition category
Condition code
Cardiovascular 312532 312532 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
a) Lung function test and cardiopulmonary exercise testing will be performed on the same day. Typically, lung function tests will be performed before exercise testing
b) Testing will be performed once at patients inclusion. Duration of lung function evaluation is 45 min and duration of cardiopulmonary exercise testing is 60 min.
c) Doctors (cardiologists) will be involved in lung function test and cardiopulmonary exercise testing as well.
d) Lung function test includes spirometry and lung plethysmography. Cardiopulmonary exercise testing includes measures of ventilation and respiratory gas parameters during cycling exercise. Measuring systems relies on breath-by-breath analysis techniques. Oxygen and carbon dioxide gas analyzers are usually incorporated in a “metabolic cart” designed specifically for functional testing. Respiratory volumes are computed by integrating the air flow signals over the time of inspiration and expiration. Average minute volumes are derived from the breath-by-breath data multiplied by the respiratory rate
Intervention code [1] 315379 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321174 0
Heart rate will be calculated by measuring real-time RR interval (milliseconds) averaged over a 10-second period by using a real time ECG monitor. Oxygen uptake (VO2) will be measured by using a metabolic card. Oxygen gas analyzer are incorporated in a “metabolic cart” designed specifically for functional testing.

A slope less than 0.8 indicates actual chronotropic incompetence.Regression line between heart rate and VO2 will be calculated offline.

Chronotropic incompetence will be ascertained by calculating the slope of the relationship between Heart rate and oxygen uptake (VO2) during exercise.
Timepoint [1] 321174 0
the day of functional testing
Secondary outcome [1] 374199 0
Post exercise heart rate recovery : Immediately after exercise cessation, participants will undergo a 3-min cool-down period. Heart rate recovery is defined as the difference between the highest observed HR (peak HR) during the graded exercise test and the heart rate after exactly 1 min and 3 min of active recovery (1-min HRR, 3-min HRR).

Heart rate will be calculated by measuring RR interval (milliseconds) averaged over a 10-second period by using a real-time ECG monitor.
Timepoint [1] 374199 0
the day of functional test

Eligibility
Key inclusion criteria
Afro-Caribbean patients with mutant transthyretin amyloid cardiomyopathy
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
coronary artery disease
unable to perform cycling
altered mental status

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data of functional evaluation will be summarized as mean and SD
Comparison with age-matched controls will be performed using t-test
(normal distribution data)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2019
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] 21806 0
Martinique
State/province [1] 21806 0
Martinique

Funding & Sponsors
Funding source category [1] 303649 0
Hospital
Name [1] 303649 0
University Hospital Martinique
Country [1] 303649 0
Martinique
Primary sponsor type
Hospital
Name
University Hospital Martinique
Address
University Hospital of Martinique (Pierre Zobda Quitman), CS 90632, 97261 Fort de France
Country
Martinique
Secondary sponsor category [1] 304385 0
None
Name [1] 304385 0
Address [1] 304385 0
Country [1] 304385 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304172 0
Institutional Review Bord University Hospital CHU Martinique
Ethics committee address [1] 304172 0
University Hospital of Martinique (Pierre Zobda Quitman), CS 90632, 97261 Fort de France, France
Ethics committee country [1] 304172 0
Martinique
Date submitted for ethics approval [1] 304172 0
16/09/2019
Approval date [1] 304172 0
01/10/2019
Ethics approval number [1] 304172 0

Summary
Brief summary
Cardiac amyloidosis (CA) is characterized by extracellular deposition of misfolded proteins that causes increased heart thickness. Exercise intolerance is among the most common complaints expressed by patients with cardiac amyloidosis due to poor cardiac performance. The aim of our study was to test whether chronotropic incompetence, and abnormal heart rate recovery would be associated with impaired aerobic capacity in ATTR patients with cardiac involvement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96042 0
Prof Neviere Remi
Address 96042 0
Department of Cardiology, CHU Martinique, University Hospital of Martinique (Pierre Zobda Quitman), CS 90632, 97261 Fort de France,
Country 96042 0
Martinique
Phone 96042 0
+596 596 55 36 04
Fax 96042 0
Email 96042 0
remi.neviere@chu-martinique.fr
Contact person for public queries
Name 96043 0
Neviere Remi
Address 96043 0
Department of Cardiology, CHU Martinique, University Hospital of Martinique (Pierre Zobda Quitman), CS 90632, 97261 Fort de France,
Country 96043 0
Martinique
Phone 96043 0
+596 596 55 36 04
Fax 96043 0
Email 96043 0
remi.neviere@chu-martinique.fr
Contact person for scientific queries
Name 96044 0
Neviere Remi
Address 96044 0
Department of Cardiology, CHU Martinique, University Hospital of Martinique (Pierre Zobda Quitman), CS 90632, 97261 Fort de France,
Country 96044 0
Martinique
Phone 96044 0
+596 596 55 36 04
Fax 96044 0
Email 96044 0
remi.neviere@chu-martinique.fr

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the de-identified participant data collected during the trial will be shared.
When will data be available (start and end dates)?
From 2/12/2019 to 2/12/2021
Available to whom?
Anyone will be able to acccess the data
Available for what types of analyses?
All types
How or where can data be obtained?
Data will be available by emailing the principal investigator (Pr Neviere) at remi.neviere@chu-martinique.fr


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
EmbaseRestrictive cardiac phenotype as primary cause of impaired aerobic capacity in Afro-Caribbean patients with val122ile variant transthyretin amyloid cardiomyopathy.2020https://dx.doi.org/10.1080/13506129.2020.1722098
N.B. These documents automatically identified may not have been verified by the study sponsor.