Targeted Potassium Levels for Prevention of ICD Therapy
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|ClinicalTrials.gov Identifier: NCT03833089|
Recruitment Status : Not yet recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Arrhythmias and Cardiac Arrest Implantable Defibrillator User Hypokalemia Hyperkalemia Ventricular Tachycardia Atrial Fibrillation||Combination Product: Targeted serum potassium level||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Arrhythmia Prevention in High Risk Cardiovascular Patients Using Targeted Potassium Levels|
|Estimated Study Start Date :||February 5, 2019|
|Estimated Primary Completion Date :||February 5, 2023|
|Estimated Study Completion Date :||February 5, 2024|
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.
Combination Product: Targeted serum potassium level
In the following order, following advices end prescriptions will be provided: 1) Potassium rich dietary advice, 2) Potassium supplementation, 3) mineralocorticoid receptor antagonists,
- 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.
- 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
- 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.
- 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.
- 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
- Time to hospitalization for electrolyte disturbances or kidney failure [ Time Frame: 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833089
|Contact: Christian Joens, MD, PhD||+1-647-562-6151||Christian.email@example.com|
|Contact: Niels Risum, MD, PhDfirstname.lastname@example.org|
|Gentofte University Hospital||Not yet recruiting|
|Gentofte, Hellerup, Denmark, 2900|
|Contact: Tommi B Lindhart, MD, PhD 38672276 email@example.com|
|Contact: Kasper K Iversen, MD, DMSc +4538686009 Kasper.firstname.lastname@example.org|
|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|