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Clinical Trials in the Netherlands / NCT07275437
Starting soon Not applicable

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

NCT07275437 · tracked via the Priya Life Science Netherlands tracker
Sponsor
University Medical Center Groningen
Phase
Not applicable
Started
2026-04-01
Last updated
2025-12-18

Condition(s) studied

Heart FailureHeart Failure and Reduced Ejection FractionHeart Failure and Mildly Reduced Ejection Fraction

Investigational drug(s) / intervention(s)

Blinded kidney function assessments

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Able and willing to give written informed consent 2. Age ≥ 18 years 3. Diagnosed with HFrEF (LVEF≤ 45%) according to criteria from 2021 European Society of Cardiology guidelines for heart failure 4. Less than 100% target dose of 2 individual reno-active GDMT classes (ACEi/ARB/ARNI, MRA or SGLT-2i) Exclusion Criteria: 1. eGFR\<25 mL/min/1.73 m2 measured up to 30 days before the first visit 2. Potassium \> 5.5 mmol/L or \<3.5 mmol/L at screening 3. Known intolerance or allergy to two individual GDMT 4. Signs of hemodynamic instability and/or cardiogenic shock 5. Decompensated heart failure requiring treatment with intravenous loop diuretics 6. Known concomitant structural kidney disease such as polycystic kidney disease or renal artery stenosis

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Onze Lieve Vrouwe Gasthuis Amsterdam North Holland
Frisius MC Leeuwarden Provincie Friesland

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Other trials for the same condition

Investigating the Impact of Nudging Cardiologists to Prescribe Guideline-directed Medical Therapy in Heart Failure Patients Enrolling by invitation
Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction Recruiting
A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity Recruiting
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure Recruiting
Guideline Implementation and Quality of Care in Patients With Heart Failure: the TITRATE-HF Registry Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07275437 on ClinicalTrials.gov ↗ ← All trials in the Netherlands