Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000705583
Ethics application status
Approved
Date submitted
10/04/2024
Date registered
4/06/2024
Date last updated
4/06/2024
Date data sharing statement initially provided
4/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcomes of Surgery for Atrial Functional Mitral Regurgitation
Scientific title
Outcomes of Surgery for Atrial Functional Mitral Regurgitation for 21 - 85 year old adults
Secondary ID [1] 311929 0
nil
Universal Trial Number (UTN)
Trial acronym
AFMR stress TTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Functional Mitral Regurgitation 333514 0
Condition category
Condition code
Cardiovascular 330195 330195 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
Patients who underwent surgery for atrial functional mitral regurgitation from January 2020 to December 2022 will be enrolled in the trial.

Patients will undergo
- Transthoracic echocardiogram (TTE)
- Electrocardiogram (ECG)
- Kansas City Cardiomyopathy Questionnaire (KCCQ-12) (approximately 20 minutes)

Patients perioperative data (type of Surgery, concomitant procedure, cardiopulmonary bypass time (CPB) time, aortic cross clamp time) will be collected retrospectively from medical records.
Intervention code [1] 328390 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337945 0
Mitral valve and left ventricular function on follow up study
Timepoint [1] 337945 0
upon recruitment. All patients are beyond 12 months post surgery.
Primary outcome [2] 337947 0
evidence of heart failure
Timepoint [2] 337947 0
upon recruitment. All patients are beyond 12 months post surgery.
Primary outcome [3] 337948 0
Exercise tolerance
Timepoint [3] 337948 0
upon recruitment. All patients are beyond 12 months post surgery.
Secondary outcome [1] 433839 0
mortality
major adverse cardiac events (MACE)
reintervention rate
rate of readmission for heart failure
Timepoint [1] 433839 0
The follow up timepoint will occur from date of mitral valve surgery for AFMR until when the patient is able to return to the hospital and attend the follow up, research related appointment (that is the follow-up timepoint). Upon recruitment, all postoperative events will be reviewed via the medical records.
Secondary outcome [2] 433840 0
health status.
Timepoint [2] 433840 0
upon recruitment, at the time of TTE. All patients are beyond 12 months post surgery.

Eligibility
Key inclusion criteria
Candidates must meet all of the following criteria to be enrolled in the study.
• Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent
• Has undergone mitral valve surgery between January 2014 to December 2022 for AFMR.
Minimum age
21 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Candidates will be excluded from enrolment in the study if any of the following conditions apply.
• Patients who have already deceased (mortality will be included in the secondary outcome).

Study design
Purpose
Duration
Selection
Defined population
Timing
Both
Statistical methods / analysis
Descriptive statistics will be analysed with parametric data reported as means (standard deviations), non-parametric data presented as median with an interquartile range, and categorical data presented as frequencies and percentages. Patient survival will be reported as hazard ratios (95% CI) and presented using a Kaplan-Meier curve.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/06/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26386 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 42360 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 316274 0
Hospital
Name [1] 316274 0
Department of Cardiothoracic Surgery and Transplantation , Alfred Hospital
Country [1] 316274 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
Country
Australia
Secondary sponsor category [1] 318463 0
None
Name [1] 318463 0
None
Address [1] 318463 0
Country [1] 318463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315093 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 315093 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 315093 0
Australia
Date submitted for ethics approval [1] 315093 0
01/12/2022
Approval date [1] 315093 0
22/05/2023
Ethics approval number [1] 315093 0

Summary
Brief summary
Functional mitral regurgitation in patients with or without atrial fibrillation without left ventricular dysfunction and/or dilatation, namely, atrial functional mitral regurgitation (AFMR), has been increasingly recognized. It occurs in the setting of left atrial dilatation and or atrial fibrillation in patients with heart failure with preserved ejection fraction (HFpEF). However, there are very limited published data regarding therapeutic strategies of AFMR. We aim to understand the optimal therapeutic options by investigating the outcomes of previously treated patients when this concept was not well recognized.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133654 0
Dr Atsuo Doi
Address 133654 0
Alfred Hospital, 55 Commercial Road, Melbourne VIC 3004
Country 133654 0
Australia
Phone 133654 0
+61 03 90763684
Fax 133654 0
Email 133654 0
[email protected]
Contact person for public queries
Name 133655 0
Atsuo Doi
Address 133655 0
Alfred Hospital, 55 Commercial Road, Melbourne VIC 3004
Country 133655 0
Australia
Phone 133655 0
+61 03 90763684
Fax 133655 0
Email 133655 0
[email protected]
Contact person for scientific queries
Name 133656 0
Atsuo Doi
Address 133656 0
Alfred Hospital, 55 Commercial Road, Melbourne VIC 3004
Country 133656 0
Australia
Phone 133656 0
+61 03 90763684
Fax 133656 0
Email 133656 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.