Sudden cardiac death in kidney disease
| ISRCTN | ISRCTN10855079 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10855079 |
| Secondary identifying numbers | 130789 |
- Submission date
- 15/01/2020
- Registration date
- 26/03/2020
- Last edited
- 26/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Chronic kidney disease (CKD) is a long-term condition where the kidneys don't work as well as they should. Cardiovascular disease is one of the main causes of death in people with kidney disease. Sudden cardiac death (SCD) is the single most common form of death in dialysis patients, accounting for 20% to 30% of all deaths in this cohort. Surprisingly little is known about actual mechanism of SCD in these patients. One reason for clearly insufficient knowledge of arrhythmias has been the lack of adequate means of detecting irregular heartbeats over extended periods of months or years.
Implantable cardiac monitors (ICM) are small devices that used for long-term monitoring of a patient's heart electrical activity.
The aim of this study is to investigate the characteristics of the heartbeat in patients with severe chronic kidney disease.
Who can participate?
Patients with stage 4 or 5 kidney disease aged 18 – 75 years.
What does the study involve?
In this study, we use insertable cardiac monitors (ICM), which is clearly the most advanced method of gathering long-term arrhythmic data. The device is implanted subcutaneously to each patient, which gives us the possibility to monitor the electrical activity of the heart constantly over the follow up of 3 years. The data is collected with remote monitoring.
What are the possible benefits and risks of participating?
The study subjects will not be given any financial remuneration, as they will not have to make extra visits to the hospital because of the study. The participants will receive thorough information about their arrhythmias in the course of the study. They will be monitored closely during the follow up period, and potential life dangering arrhythmias can be detected and a pacemaker implanted when needed.
The subcutaneous implantation of insertable cardiac monitor with local anesthesia is a minor procedure with a minimal risk of complications. Infections and minor bleeding related to implantation of the cardiac monitors are possible, though unlikely, risks for the participants. Other tests performed in the study are noninvasive. The study group has extensive experience with all the tests and devices used in the study, including insertable cardiac monitors.
Where is the study run from?
Päijät-Häme Central Hospital, Finland
When is the study starting and how long is it expected to run for?
November 2011 to December 2020
Who is funding the study?
1. Medtronic Ltd, USA
2. Onni ja Hilja Tuovinen Fund, Finland
Who is the main contact?
Dr Joonas Rautavaara
joonas.rautavaara@gmail.com
Contact information
Public
Keskussairaalantie 7
Lahti
15850
Finland
| Phone | +35 8381911 |
|---|---|
| joonas.rautavaara@phhyky.fi |
Study information
| Study design | Observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Sudden cardiac death and arrhythmias in end-stage renal disease |
| Study acronym | KSCD |
| Study objectives | What are the most common arrhythmias in patients with end-stage renal disease in different dialysis modalities, which are the factors affecting the prevalence and incidence of these arrhythmias? |
| Ethics approval(s) | Approved 14/10/2011, Ethics Committee of the Pirkanmaa Hospital District (The Ethics Committee of Pirkanmaa Hospital District, Post box 2000, 33521, Tampere, Finland; +358 50 329 5667; minna.maa.lahtinen@pshp.fi), ref: R11138 / 2011 |
| Health condition(s) or problem(s) studied | End-stage kidney disease stage IV and V |
| Intervention | The continuous rhythm monitoring of among the participants of the study was carried out using the Medtronic ICMs (Reveal® DX, Reveal XT™ and Reveal Linq™) (Medtronic Inc, Minneapolis, MN, USA). ICMs will be implanted subcutaneously on the left side of the chest using local anaesthesia. Data retrieval from Reveal XT is performed noninvasively via an induction link when the patients visited the hospital for dialysis or for a routine check-up. The participants have an ambulatory 24-hour ECG recording at the beginning of the study and once a year thereafter. At the beginning of the study, an echocardiogram is performed for each participant. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Medtronic ICMs (Reveal® DX, Reveal XT™ and Reveal Linq™) |
| Primary outcome measure | Presence and burden of atrial fibrillation, atrial flutter, bradycardia, sustained and non-sustained ventricular tachycardia, ventricular premature contractions, asystole and ventricular fibrillation are quantified using the data from insertable cardiac monitors over the course of the follow-up time of 3 years |
| Secondary outcome measures | 1. Temporal association between dialysis and the arrhythmias using the data from insertable cardiac monitors over the course of the follow-up time of 3 years 2. Prevalence of arrhythmias using the data from insertable cardiac monitors over the course of the follow-up time of 3 years. 3. Survival at 3 years measured using patient records. |
| Overall study start date | 13/09/2011 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Stage 4 (pre-dialysis, glomerular filtration rate 15-29 mL/min/1.73m²) or stage 5 (end-stage renal disease, <15 mL/min/1.73m² or dialysis) 2. Planned active treatment is either hemodialysis or peritoneal dialysis, or kidney transplantation. The hemodialysis also includes short daily home hemodialysis |
| Key exclusion criteria | 1. Age >75 years 2. Age <18 years 3. Presence of a non-cardiovascular and non-renal disease which limits the expected life-span to less than 1 year 4. Probable noncompliance |
| Date of first enrolment | 09/11/2011 |
| Date of final enrolment | 31/12/2019 |
Locations
Countries of recruitment
- Finland
Study participating centres
Lahti
15850
Finland
Helsinki
00290
Finland
Jyväskylä
40620
Finland
Pori
28500
Finland
Vaasa
65100
Finland
Sponsor information
Hospital/treatment centre
Keskussairaalankatu 7
Lahti
15850
Finland
| Phone | +35 00381911 |
|---|---|
| tuomo.nieminen@phhyky.fi | |
| Website | https://www.phhyky.fi/fi/etusivu/ |
"ROR" |
https://ror.org/02v92t976 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medtronic Inc.
- Location
- United States of America
No information available
Results and Publications
| Intention to publish date | 30/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | During year 2020 we intend to publish the prevalence of atrial fibrillation and bradyarrhythmias and the factors associated with if. Later this year, we also intend to compare the effect of different dialysis modalities and kidney transplantation on the incidence of new arrhythmias. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. Due to the limited number of patients in some participating hospitals, the patients could be identifiable even from the anonymized data sets. According to the concent form signed by the patients, data will be treated confidentially and handled only by the investigators and study nurses. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v1.7 | 14/06/2019 | 26/03/2020 | No | No |
Additional files
- ISRCTN10855079_PROTOCOL_v1.7_14Jun19.pdf
- uploaded 26/03/2020
Editorial Notes
26/03/2020: Uploaded protocol (not peer reviewed) as an additional file.
21/02/2020: Trial’s existence confirmed by Ethics Committee of the Pirkanmaa Hospital District.
