Condition category
Urological and Genital Diseases
Date applied
15/01/2020
Date assigned
26/03/2020
Last edited
26/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Joonas Rautavaara

ORCID ID

Contact details

Keskussairaalantie 7
Lahti
15850
Finland
+35 8381911
joonas.rautavaara@phhyky.fi

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

130789

Study information

Scientific title

Sudden cardiac death and arrhythmias in end-stage renal disease

Acronym

KSCD

Study hypothesis

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

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

Study design

Observational study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Not Applicable

Drug names

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 trial start date

13/09/2011

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant 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

Recruitment start date

09/11/2011

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Finland

Trial participating centre

Päijät-Häme Central Hospital
Keskussairaalankatu 7
Lahti
15850
Finland

Trial participating centre

Helsinki University Hospital
Haartmaninkatu 4 Rakennus 3
Helsinki
00290
Finland

Trial participating centre

Central Hospital of Central Finland
Keskussairaalantie 19
Jyväskylä
40620
Finland

Trial participating centre

Satakunta Central Hospital
Sairaalantie 3
Pori
28500
Finland

Trial participating centre

Vaasa Central Hospital
Hietalahdenkatu 2-4
Vaasa
65100
Finland

Sponsor information

Organisation

Päijät-Hämeen Keskussairaala

Sponsor details

Keskussairaalankatu 7
Lahti
15850
Finland
+35 00381911
tuomo.nieminen@phhyky.fi

Sponsor type

Hospital/treatment centre

Website

https://www.phhyky.fi/fi/etusivu/

Funders

Funder type

Industry

Funder name

Medtronic

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)

Location

United States of America

Funder name

Onni ja Hilja Tuovinen Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement:
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.

Intention to publish date

30/06/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

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.