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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Blinded kidney function assessments

Treatment groups

344 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Medical Center Groningen

Lead sponsor

Onze Lieve Vrouwe Gasthuis

Collaborator

Frisius Medisch Centrum

Collaborator