Heart FailureRESUME-HFNCT07275437
Effectiveness and Safety of Uptitration of Guideline Directed MEdical Therapy in Heart Failure With Reduced Ejection Fraction With Limited Kidney Function Assessments
A study testing Blinded kidney function assessments in people with Heart Failure and Heart Failure and Reduced Ejection Fraction, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure and Reduced Ejection Fraction, Heart Failure and Mildly Reduced Ejection Fraction
- What is being tested?
- Blinded kidney function assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Apr 2026to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1090 HM
Dr. P.E.J. van Pol, MD, +31 (0)20 599 91 11, p.e.j.vanpol@olvg.nl
Petra E.J. van Pol, MD
Frisius MC
Leeuwarden, Provincie Friesland, 8934 AD
Dr. C. da Fonseca MD, +31 (0)20 599 91 11, carlos.da.fonseca@mcl.nl
Carlos da Fonseca, MD
About this study
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)
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.
Read the 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).
- Conditions
- Heart Failure, Heart Failure and Reduced Ejection Fraction, Heart Failure and Mildly Reduced Ejection Fraction
- Being tested
- Blinded kidney function assessments
- Keywords
- Guideline-Directed Medical Therapy, Limited Kidney Function Assessments
- Medical subject headings
- Heart Failure, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinded kidney function assessmentsOther
Kidney function results will be blinded in the intervention group, except at baseline, three months, and six months.
| Study group | Role | What they receive |
|---|---|---|
| Limited number of kidney function assessments | Experimental | Participants in this arm will have standardized kidney function assessments at baseline, three months, and six months. Kidney function assessments in between these moments will be blinded in the electronic patient dossier. Unblinding will be performed if the results are significantly abnormal. Receives: Other: Blinded kidney function assessments |
| Control | No intervention | Participants will receive standard care, which includes frequent kidney function assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The achieved average percentage dose of reno-active GDMT at 6 months relative to optimal dose.
Measured: 6 months
Secondary outcomes (2)
The achieved percentage dose of the individual reno-active GDMT drug classes at 6 months relative to optimal dose.
Measured: 6 months
The time to first occurrence of unplanned heart failure visit, heart failure hospitalization, or all-cause mortality till 9 months.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Onze Lieve Vrouwe Gasthuis, Frisius Medisch Centrum
- Responsible party
- Principal investigator, Jozine ter Maaten, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275437
- Sponsor's protocol ID
- 22833
- Acronym
- RESUME-HF
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07275437
- Acronym / sponsor ID
- RESUME-HF / 22833
- Conditions
- Heart Failure, Heart Failure and Reduced Ejection Fraction, Heart Failure and Mildly Reduced Ejection Fraction
- Keywords
- Guideline-Directed Medical Therapy, Limited Kidney Function Assessments
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Onze Lieve Vrouwe Gasthuis, Frisius Medisch Centrum
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limited number of kidney function assessments | Experimental | Other: Blinded kidney function assessmentsParticipants in this arm will have standardized kidney function assessments at baseline, three months, and six months. Kidney function assessments in between these moments will be blinded in the electronic patient dossier. Unblinding will be performed if the results are significantly abnormal. |
| Control | No intervention | –Participants will receive standard care, which includes frequent kidney function assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blinded kidney function assessmentsKidney function results will be blinded in the intervention group, except at baseline, three months, and six months. | Other | Limited number of kidney function assessments |
Primary outcome
The achieved average percentage dose of reno-active GDMT at 6 months relative to optimal dose.
Time frame: 6 months
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blinded kidney function assessments in people with Heart Failure and Heart Failure and Reduced Ejection Fraction, run by University Medical Center Groningen at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The achieved average percentage dose of reno-active GDMT at 6 months relative to optimal dose. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.