Status:
ACTIVE_NOT_RECRUITING
Targeted Potassium Levels for Prevention of ICD Therapy
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Herlev and Gentofte Hospital
Conditions:
Ventricular Arrhythmias and Cardiac Arrest
Implantable Defibrillator User
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 antagonist...
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...
Eligibility Criteria
Inclusion
- Implantable cardioverter defibrillator (ICD) or cardiac resynchronization pacemaker with ICD (CRT-D).
- Age \>18 years
Exclusion
- Estimated glomerular filtration rate (eGFR) \<30 ml/h
- Pregnancy
- Lack of ability to understand and sign informed consent
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2035
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT03833089
Start Date
March 1 2019
End Date
April 1 2035
Last Update
May 9 2025
Active Locations (3)
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1
Gentofte University Hospital
Gentofte Municipality, Hellerup, Denmark, 2900
2
Roskilde University Hospital
Roskilde, Region Sjælland, Denmark, 4000
3
Rigshospitalet
Copenhagen, Denmark, 2100