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.
Able and willing to give written informed consent
Age ≥ 18 years
Diagnosed with HFrEF (LVEF≤ 45%) according to criteria from 2021 European Society of Cardiology guidelines for heart failure
Less than 100% target dose of 2 individual reno-active GDMT classes (ACEi/ARB/ARNI, MRA or SGLT-2i)
eGFR<25 mL/min/1.73 m2 measured up to 30 days before the first visit
Potassium > 5.5 mmol/L or <3.5 mmol/L at screening
Known intolerance or allergy to two individual GDMT
Signs of hemodynamic instability and/or cardiogenic shock
Parallel
Blinded kidney function assessments
Other interventionKidney function results will be blinded in the intervention group, except at baseline, three months, and six months.
The achieved average percentage dose of reno-active GDMT at 6 months relative to optimal dose.
The achieved percentage dose of the individual reno-active GDMT drug classes at 6 months relative to optimal dose.
The time to first occurrence of unplanned heart failure visit, heart failure hospitalization, or all-cause mortality till 9 months.
The achieved average percentage dose of all GDMT at 6 months relative to optimal dose.
Percentage change in NT-pro BNP at 6 months
Percentage change in loop diuretics at 6 months
Safety endpoint
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
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University Medical Center Groningen
Lead sponsor
Onze Lieve Vrouwe Gasthuis
Collaborator
Frisius Medisch Centrum
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
