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NOT YET RECRUITING
NCT07275437
NA

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

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Controlled Trial Investigating the Effectiveness and Safety of Uptitration of Guideline Directed MEdical Therapy in Heart Failure With a Reduced Ejection Fraction With Limited Standardized Kidney Function Assessments (RESUME-HF-Kidney)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

344

Start Date

2026-04-01

Completion Date

2030-01-01

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

OTHER

Blinded kidney function assessments

Kidney function results will be blinded in the intervention group, except at baseline, three months, and six months.

Locations (2)

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, Netherlands

Frisius MC

Leeuwarden, Provincie Friesland, Netherlands