Targeted Potassium Levels for Prevention of ICD Therapy

NCT ID: NCT03833089

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2035-04-01

Brief Summary

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.

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

Conditions

Ventricular Arrhythmias and Cardiac Arrest; Implantable Defibrillator User; Hypokalemia; Hyperkalemia; Ventricular Tachycardia; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

ICD recipients in optimal Medical treatment as per guidelines according to their comorbidity

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Targeted serum potassium level

Intervention Type: 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,

Interventions

Targeted serum potassium level

In the following order, following advices end prescriptions will be provided: 1) Potassium rich dietary advice, 2) Mineralocorticoid receptor antagonists, 3) Potassium supplementation,

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herlev and Gentofte Hospital

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Christian Joens

Staff Cardiologist, Electrophysiology, Principal investigator, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian Joens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Cardiology, Rigshospitalet, Denmark

Niels Risum, MD, PhD

Role: STUDY_CHAIR

Dept of Cardiology, Rigshospitalet, Denmark

Henning Bundgaard, Prof., DMSc

Role: STUDY_CHAIR

Dept of Cardiology, Rigshospitalet, Denmark

Locations

Gentofte University Hospital

Gentofte Municipality, Hellerup, Denmark

Roskilde University Hospital

Roskilde, Region Sjælland, Denmark

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

References

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 Aug 29. doi: 10.1056/NEJMoa2509542. Online ahead of print.

Reference Type: DERIVED

PMID: 40879429 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37467227 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

3589

Identifier Type: -

Identifier Source: org_study_id