- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03833089
Targeted Potassium Levels for Prevention of ICD Therapy
Arrhythmia Prevention in High Risk Cardiovascular Patients Using Targeted Potassium Levels
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There is solid evidence that potassium-sparing drugs increase survival and ameliorates symptoms in heart failure patients and post-hoc studies have suggested that high-normal levels of blood potassium levels (p-K) markedly decreases the risk of malignant arrhythmias in cardiovascular patients.
This trial will randomize patients implanted with implantable cardioverter defibrillators (ICDs), who remain at high risk of life-threatening cardiac arrhythmias, to a standard therapy or standard therapy plus a regimen to keep high-normal p-K levels. The study will enroll 1,000 patients from the outpatient pacemaker clinics at Rigshospitalet and Gentofte hospital. Using a planned regime to increase p-K using inexpensive drugs and potassium supplements, the patients enrolled and followed with regular controls as well as continuous monitoring using existing home monitoring systems over a period of 4 years for the primary endpoint of appropriate ICD therapy and all cause mortality. Including analysis, the trial will be running for 5 years
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Christian Joens, MD, PhD
- Phone Number: +1-647-562-6151
- Email: Christian.joens.02@regionh.dk
Study Contact Backup
- Name: Niels Risum, MD, PhD
- Phone Number: +4523456073
- Email: niels.risum.01@regionh.dk
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Recruiting
- Rigshospitalet
-
Contact:
- Christian Joens, MD
- Phone Number: +4535459863
- Email: christian.joens.02@regionh.dk
-
Contact:
- Henning Bundgaard, Professor
- Phone Number: +35450512
- Email: henning.bundgaard@regionh.dk
-
Sub-Investigator:
- Niels Risum, MD
-
Sub-Investigator:
- Ulrik Winsloew, MD
-
-
Hellerup
-
Gentofte, Hellerup, Denmark, 2900
- Recruiting
- Gentofte University Hospital
-
Contact:
- Tommi B Lindhart, MD, PhD
- Phone Number: 38672276
- Email: tommi.bo.lindhart@regionh.dk
-
Contact:
- Kasper K Iversen, MD, DMSc
- Phone Number: +4538686009
- Email: Kasper.karmark.iversen@regionh.dk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Implantable cardioverter defibrillator (ICD) or cardiac resynchronization pacemaker with ICD (CRT-D).
- Age >18 years
Exclusion Criteria:
- Estimated glomerular filtration rate (eGFR) <30 ml/h
- Pregnancy
- Lack of ability to understand and sign informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
ICD recipients in optimal Medical treatment as per guidelines according to their comorbidity
|
|
Experimental: Targeted serum potassium levels
ICD recipients recipients in optimal Medical treatment as per guidelines according to their comorbidity.
In addition to guideline recommended treatment, this cohort will be treated to increase serum potassium levels to 4.5-5.0
mEq/L.
|
In the following order, following advices end prescriptions will be provided: 1) Potassium rich dietary advice, 2) Potassium supplementation, 3) mineralocorticoid receptor antagonists,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to first major event defined as a combination of: - first occurence of ECG documented ventricular tachycardia > 125 bpm lasting > 30 seconds - first occurence of any appropriate ICD therapy as documented by the ICD - All cause mortality
Time Frame: 4 years
|
The time period with regards to the Time-to-Event Outcome Measures starts with the randomization of the patient. ECG documented tachycardia from ECGs or ICD interrogations will be obtained from hospitalizations or outpatients clinic visits via electronic records after patient consent. Information of ventricular tachyarrhythmia therapy will be obtained from home monitoring systems or interrogation of the ICD devices during in-clinic visits. Mortality will be obtained from danish electronic hospital files or the danish death registry. |
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to first incidence of supraventricular arrhythmias as documented by ECG or the ICD
Time Frame: 4 years
|
Any supraventricular tahcycardia documented on ECG, telemetry or as monitored/treated event on the ICD
|
4 years
|
Proportion of patients experiencing <92 % CRT-pacing for > 2 weeks (only CRT-D patients)
Time Frame: 4 years
|
CRT-D home monitoring systems allow temporal evaluation of percentage of CRT pacing.
|
4 years
|
Time to first hospitalization for heart failure
Time Frame: 4 years
|
Hospitalization with symptoms of heart failure and with a diagnosis of heart failure where treatment with i.v.
diuretics was initiated.
|
4 years
|
Time to first hospitalization for cardiac arrhythmias
Time Frame: 4 years
|
Hospitalization were records indicate that supraventricular or ventricular arrhythmias were implicated in the cause of the hospitalization
|
4 years
|
Time to hospitalization for electrolyte disturbances or kidney failure
Time Frame: 4 years
|
4 years
|
|
First occurrence of appropriate ICD therapy for ventricular tachycardia or ventricular fibrillation irrespective of outcome.
Time Frame: 4 years
|
Ventricular tachy-arrhythmia therapy, which will be obtained from home monitoring systems or interrogation of the ICD devices during in-clinic visits.
All ICD therapy is routinely adjudicated as appropriate or in-appropriate by electrophysiologists at the study sites.
|
4 years
|
Time to first occurence of inappropriate ICD therapy
Time Frame: 4 years
|
Any cause of inappropriate shock including atrial fibrillation, other supraventricular arrhythmias, ICD lead problems etc.
|
4 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christian Joens, MD, PhD, Dept of Cardiology, Rigshospitalet, Denmark
- Study Chair: Niels Risum, MD, PhD, Dept of Cardiology, Rigshospitalet, Denmark
- Study Chair: Henning Bundgaard, Prof., DMSc, Dept of Cardiology, Rigshospitalet, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3589
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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