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

Objective: To assess the effect of a reduction in kidney function assessments during optimalization of GDMT in patients with HFrEF on the achieved GDMT doses, safety, and clinical outcomes. Study design: Randomized, controlled open-label study Study population: 344 patients with new-onset or sub-optimally treated HFrEF referred to the outpatient clinic for optimalization of GDMT Intervention (if applicable): Randomization to limited number of kidney function assessments or standard of care Primary endpoint: The achieved average percentage dose of reno-active GDMT at 6 months relative to optimal dose. Secondary endpoints: The achieved percentage dose of the individual reno-active GDMT drug classes at 6 months relative to optimal dose, and time to first occurrence of unplanned heart failure visit, heart failure hospitalization, or all-cause mortality till 9 months. Safety endpoints: Incidence of doubling of creatinine, estimated glomerular filtration rate (eGFR) \<20 mL/min/1.73 m2, potassium \>6 mmol/L, or potassium \<3.5 mmol/L at any timepoint. An additional composite kidney endpoint is defined as a combination of hospitalization for kidney failure, dialysis or end-stage kidney disease (eGFR \<15 mL/min/1.73 m2).