NCT07275437Not yet recruiting
Effectiveness and Safety of Uptitration of Guideline Directed MEdical Therapy in Heart Failure With Reduced Ejection Fraction With Limited Kidney Function Assessments
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)
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 344 (estimated)
- First submitted
- 27 Nov 2025
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Jan 2030
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Heart failure
- NCT number
- NCT07275437
What you commit to
- Study type: Interventional
- Planned participants: 344
- From 1 Apr 2026 to the primary completion date, 1 Jan 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Decompensated heart failure requiring treatment with intravenous loop diuretics
- Known concomitant structural kidney disease such as polycystic kidney disease or renal artery stenosis
Other illness
- Known intolerance or allergy to two individual GDMT
Lab values
- 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
Other
- Signs of hemodynamic instability and/or cardiogenic shock
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Onze Lieve Vrouwe Gasthuis Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Frisius MC Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.