Effectiveness and Safety of Uptitration of Guideline Directed MEdical Therapy in Heart Failure With Reduced Ejection Fraction With Limited Kidney Function Assessments

Guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) constitutes of four medications that substantially reduce morbidity and mortality, and improve quality of life. In routine clinical practice, various physician- and patient-related factors lead to suboptimal initiation and uptitration of GDMT to optimal dosing, which is associated with worse patient outcomes. A perceived major barrier to the optimalization of GDMT are changes in kidney function and electrolytes, which prompts physicians to halt uptitration, reduce doses, or even discontinue GDMT. Changes in kidney function and electrolytes during optimalization of GDMT are common, but not associated with adverse events. The hypothesis of this study is that a reduction in the number of kidney function assessments during initiation and uptitration of GDMT in HFrEF patients will lead to higher achieved doses of GDMT without safety concerns.

NCT Number	NCT07275437
Lead Sponsor	University Medical Center Groningen Collaborators: Onze Lieve Vrouwe Gasthuis, Frisius Medisch Centrum
Conditions	Heart Failure, Heart Failure and Reduced Ejection Fraction, Heart Failure and Mildly Reduced Ejection Fraction
Enrollment	344 participants
Start Date	2026-04-01
Primary Completion	2030-01-01 (estimated)
Study Completion	2030-01-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-18