Effectiveness and Safety of Uptitration of Guideline Directed MEdical Therapy in Heart Failure With Reduced Ejection Fraction With Limited Kidney Function Assessments
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blinded kidney function assessments.
- Who it may be relevant to
- Registry conditions: Heart Failure, Heart Failure and Reduced Ejection Fraction, Heart Failure and Mildly Reduced Ejection Fraction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
Detailed description
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).
Interventions
- Other Blinded kidney function assessments
Kidney function results will be blinded in the intervention group, except at baseline, three months, and six months.
Primary outcome measures
- The achieved average percentage dose of reno-active GDMT at 6 months relative to optimal dose. [Time frame: 6 months]
Secondary outcome measures (2)
- The achieved percentage dose of the individual reno-active GDMT drug classes at 6 months relative to optimal dose. [Time frame: 6 months]
- The time to first occurrence of unplanned heart failure visit, heart failure hospitalization, or all-cause mortality till 9 months. [Time frame: 9 months]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
- Decompensated heart failure requiring treatment with intravenous loop diuretics
- Known concomitant structural kidney disease such as polycystic kidney disease or renal artery stenosis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 2 centers
- Onze Lieve Vrouwe Gasthuis — Amsterdam
- Frisius MC — Leeuwarden
Identifiers
NCT: NCT07275437 · 22833