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| Name | Class |
|---|---|
| Herlev and Gentofte Hospital | OTHER |
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This study evaluates whether a rigorously controlled high-normal level of serum-potassium (4.5-5.0 mEq/L) using dietary recommendations, potassium supplements and mineralocorticoid receptor antagonists will results in a lower incidence of cardiac arrhythmias in patients with an ICD. Patients will be randomized to this treatment or a control arm, where patients will receive usual guideline recommended follow-up.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | ICD recipients in optimal Medical treatment as per guidelines according to their comorbidity | |
| Targeted serum potassium levels | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted serum potassium level | Combination Product | In the following order, following advices end prescriptions will be provided: 1) Potassium rich dietary advice, 2) Mineralocorticoid receptor antagonists, 3) Potassium supplementation, |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first occurrence of ECG documented ventricular tachycardia, appropriate ICD therapy, hospitalization > 24 hours due to arrhythmias and/or heart failure leading to a change in treatment and all cause mortality | A combination of:
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. | Total 291 events, expected 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first incidence of supraventricular arrhythmias as documented by ECG or the ICD | Any supraventricular tahcycardia documented on ECG, telemetry or as monitored/treated event on the ICD | 6 years |
| Proportion of patients experiencing <92 % CRT-pacing for > 2 weeks (only CRT-D patients) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Joens, MD, PhD | Dept of Cardiology, Rigshospitalet, Denmark | Principal Investigator |
| Niels Risum, MD, PhD | Dept of Cardiology, Rigshospitalet, Denmark | Study Chair |
| Henning Bundgaard, Prof., DMSc | Dept of Cardiology, Rigshospitalet, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gentofte University Hospital | Gentofte Municipality | Hellerup | 2900 | Denmark | ||
| Roskilde University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41923135 | Derived | Sakthivel T, Winslow UC, Zheng C, Danielsen EM, Bosselmann HS, Vinther M, Bruun NE, Bundgaard H, Jons C, Risum N. Effects of plasma potassium on myocardial function: a POTCAST substudy. J Cardiovasc Imaging. 2026 Apr 2;34(1):7. doi: 10.1186/s44348-026-00068-7. | |
| 40879429 | Derived | Jons C, Zheng C, Winslow UCG, Danielsen EM, Sakthivel T, Frandsen EA, Saffi H, Vakilzadeh-Hashemi SS, Haugan KJ, Bruun NE, Iversen KK, Bosselmann HS, Risum N, Bundgaard H; POTCAST Study Group. Increasing the Potassium Level in Patients at High Risk for Ventricular Arrhythmias. N Engl J Med. 2025 Nov 20;393(20):1979-1989. doi: 10.1056/NEJMoa2509542. Epub 2025 Aug 29. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2025 | Feb 5, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D007008 | Hypokalemia |
| D006947 | Hyperkalemia |
| D017180 | Tachycardia, Ventricular |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
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CRT-D home monitoring systems allow temporal evaluation of percentage of CRT pacing. |
| 6 years |
| Time to first hospitalization for heart failure | Hospitalization with symptoms of heart failure and with a diagnosis of heart failure where treatment with i.v. diuretics was initiated. | 6 years |
| Time to first hospitalization for cardiac arrhythmias | Hospitalization were records indicate that supraventricular or ventricular arrhythmias were implicated in the cause of the hospitalization | 6 years |
| Time to hospitalization for electrolyte disturbances or kidney failure | Hospitalization were records indicate that kidney failure or disturbances in the potassium or sodium plasma leves were implicated in the cause of the hospitalization | 6 years |
| First occurrence of appropriate ICD therapy for ventricular tachycardia or ventricular fibrillation irrespective of outcome. | 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. | 6 years |
| Time to first occurence of inappropriate ICD therapy | Any cause of inappropriate shock including atrial fibrillation, other supraventricular arrhythmias, ICD lead problems etc. | 6 years |
| Roskilde |
| Region Sjælland |
| 4000 |
| Denmark |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| 37467227 | Derived | Winslow U, Sakthivel T, Zheng C, Bosselmann H, Haugan K, Bruun N, Larroude C, Iversen K, Saffi H, Frandsen E, Oturai P, Jensen HJ, Vinther M, Risum N, Bundgaard H, Jons C. Treatment-induced increase in total body potassium in patients at high risk of ventricular arrhythmias; a randomized POTCAST substudy. PLoS One. 2023 Jul 19;18(7):e0288756. doi: 10.1371/journal.pone.0288756. eCollection 2023. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |