Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202104866174807 Date of Approval: 14/04/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Use of small implantable ECG recorder in women with peripartum cardiomyopathy
Official scientific title Use of small implantable ECG recorder in women with peripartum cardiomyopathy
Brief summary describing the background and objectives of the trial In peripartum cardiomyopathy (PPCM), sudden cardiac death is believed to contribute to about one third of all-cause mortality. (Sliwa K Eur Heart Jour 2020) Sudden cardiac death has been reported in PPCM patients with decreased left ventricular ejection fraction (LVEF) in both the acute and chronic stage of this disease, as well as in those whose LVEF has completely normalized (Forster et al. Eur J. of Heart Fail 2008), indicating that the risk of sudden cardiac death may persist well into recovery in this patient population. Patients with sustained ventricular arrhythmias or a familial history of sudden cardiac death in the acute setting may be candidates for ICD implantation, but this decision must be carefully weighed against the evidence that LV function normalizes within six months in many PPCM patients. It would not be unreasonable to consider ICD implantation in patients with persistent NYHA class III or IV symptoms despite optimal medical therapy for six months and whose LVEF remains <30%. However, in the South African set-up, ICDs are given to patients for secondary prevention only because of financial constraints. Therefore, identifying VT/VF or frequent NSVT in patients with PPCM would change management. A single-centre, observational outcome study, investigating women with PPCM presenting with symptoms and signs of arrhythmia. We aim to recruit 20 consecutive women with PPCM with an indication for the REVEAL device, from a population of about 200 pregnant women with documented or suspected cardiovascular disease as part of the ongoing cardiovascular disease in pregnancy registry. Primary Objective: To investigate if the REVEAL devices in patients with PPCM will change management compared to a single ECG done at presentation Secondary Objective(s) To document life-threatening arrhythmias (ventricular tachycardia/ventricular fibrillation) and identifying patients for ICD (for secondary prevention).
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 12/05/2017
Actual trial start date
Anticipated date of last follow up 21/09/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group 24h Holter Monitoring N/A 24h 24h Holter monitoring to detect arrhythmias. 10 Uncontrolled
Experimental Group Implantable Loop recorder N/A 1 year The REVEAL device is the size of a larger USB stick and will be inserted under the skin using local anaesthetic under sterile conditions as a minor procedure. There are no wires connecting it to the cardiac chambers or any vessels. The device can record the cardiac rhythm for a period of up to one year. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients with a confirmed diagnosis of PPCM - Age greater than 18 years - Patients willing and able to give informed consent - Patient is able (in the investigators’ opinion) to comply with all study requirements and return for follow-up - Patients who are unable to give informed consent Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/05/2017 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Main Rd, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Determine the burden of arrhythmias occurring in PPCM by means of ambulatory ECG monitoring by 24h Holter and ILR 1-month, 3-months, 6-months and 1 year.
Secondary Outcome 1. To document incidence of life-threatening arrhythmias as detected by Holter monitoring versus implantable loop recorder (amongst those with an LVEF ≤ 35% vs > 35%). 2. To document atrial tachyarrhythmia’s (atrial fibrillation, atrial flutter) to identify potential candidates for anticoagulation. 3. To determine average heart rate and the burden of sinus tachycardia on Holter monitoring (amongst those with an LVEF ≤ 35% vs > 35%). 1-month, 3-months, 6-months and 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Groote Schuur Hospital Main Rd, Observatory Cape Town 7925 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Medtronic Africa Bridal Veil St Midrand 1685 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medtronic Bridal Veil St Midrand 1685 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Julian Hoevelmann julian.hovelmann@uct.ac.za +27214066358 3 Anzio Rd
City Postal code Country Position/Affiliation
Cape Town 7935 South Africa Research Fellow Cape Heart Institute
Role Name Email Phone Street address
Principal Investigator Karen Sliwa karen.sliwa-hahnle@uct.ac.za +27214066358 3 Anzio Rd
City Postal code Country Position/Affiliation
Cape Town 7935 South Africa Director of the Cape Heart Institute
Role Name Email Phone Street address
Public Enquiries Olivia Briton olivia.briton@uct.ac.za +27214066358 3 Anzio Rd
City Postal code Country Position/Affiliation
Cape Town 7935 South Africa Research Nurse Cape Heart Institute
Role Name Email Phone Street address
Scientific Enquiries Charle Viljoen charle.viljoen@uct.ac.za +27214066358 3 Anzio Rd
City Postal code Country Position/Affiliation
Cape Town South Africa Medical Doctor
Role Name Email Phone Street address
Scientific Enquiries Ashley Chin ashley.chin@uct.ac.za +27214066358 3 Anzio Rd
City Postal code Country Position/Affiliation
Cape Town South Africa Medical Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We hereby acknowledge that it is a requirement to upload a link to the summary results of the trial. We will do so upon completion of the study and manuscript preparation. Study Protocol Patient recruitment completed in 2020 Data analysis 2021 Manuscript preparation 2021/2022 Will be updated during manuscript preparation.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information