Heart FailureReQUAD-HFNCT06273280
Renal-based Optimization of QUADruple Therapy in Patients With Heart Failure With Reduced Ejection Fraction.
A study testing SOC and Protocolized up-titration in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
The goal of this clinical trial is to evaluate guideline-directed medical therapy (GDMT) up-titration in patients with heart failure with reduced ejection fraction.The main question it aims to answer is the improvement in prescription rate and dose uptitration of quadruple GDMT in patients with HFrEF, assessed by a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- SOC and Protocolized up-titration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Feb 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Left ventricular ejection fraction ≤ 40%, assessed LVEF with imaging within last three months before randomization (TTE/KT/MIBI/MRI)
- NYHA ≥ II
Who cannot join
- Hemodynamic instability
- Recent acute coronary syndrome (< 1 month before randomisation)
- Already on quadruple heart failure therapy or on triple GDMT in case of eGFR < 30ml/min/1.73m2 or a potassium above 6mmol/L
- eGFR < 20ml/min/1.73², planned for dialysis or already actively treated with chronic dialysis.
- Implantation of a cardiac resynchronization therapy (CRT) within 3 months
- Adult congenital heart disease
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- Previous heart transplantation or currently/planned for ventricular assist device
- Women who are pregnant or breastfeeding
- Unable to participate in 3 months follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renal-based Optimization of QUADruple Therapy in Patients With Heart Failure With Reduced Ejection Fraction: a Prospective, Multicentre, International Randomized Study
The goal of this clinical trial is to evaluate guideline-directed medical therapy (GDMT) up-titration in patients with heart failure with reduced ejection fraction.The main question it aims to answer is the improvement in prescription rate and dose uptitration of quadruple GDMT in patients with HFrEF, assessed by a weighed composite score.
Participants will be randomized towards control (standard of care, SOC) or intervention group.
Researchers will compare SOC with protocol-based up-titration to see if the protocolized optimization improves prescription rate of GDMT.
- Being tested
- SOC, Protocolized up-titration
- Keywords
- heart failure, heart failure with reduced ejection fraction, guideline-directed medical therapy, quadruple therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOCProcedure or surgery
Physician-guided GDMT up-titration
Protocolized up-titrationProcedure or surgery
Renal-based protocolized GDMT up-titration
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Up-titration of GDMT at the discretion of the treating physician. Receives: Procedure: SOC |
| Intervention | Experimental | Uptitration of GDMT according to the renal-based approach postulated by the Heart Failure Association of the European Society of Cardiology (HFA-ESC) Receives: Procedure: Protocolized up-titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighed composite score of maximal guideline-directed medical therapy
The composite score of maximal guideline-directed medical therapy 3 months after inclusion.(minimum score 0, maximum score 15)
Measured: 3 months
Secondary outcomes (3)
All-cause mortality and heart failure hospitalizations
All-cause mortality and heart failure hospitalization after three months of follow-up
Measured: 3 months
Change in NTproBNP
Change in NT-proBNP over 3 months
Measured: 3 months
Change in renal function
Change in eGFR, calculated with the CKD-EPI formula
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start14 Feb 2024
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (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.
- 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
- Model description
- This is a prospective, randomized-controlled trial. Due to the design, the study is open-label, but the endpoint assessment is blinded.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 345 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- King Baudouin Foundation
- Responsible party
- Sponsor
- Investigators
- Wilfried Mullens, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273280
- Sponsor's protocol ID
- Z-2023025
- Acronym
- ReQUAD-HF
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal-based Optimization of QUADruple Therapy in Patients With Heart Failure With Reduced Ejection Fraction: a Prospective, Multicentre, International Randomized Study
- ClinicalTrials.gov ID
- NCT06273280
- Acronym / sponsor ID
- ReQUAD-HF / Z-2023025
- Keywords
- heart failure, heart failure with reduced ejection fraction, guideline-directed medical therapy, quadruple therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Collaborators
- King Baudouin Foundation
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 22 Feb 2024 (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.
The goal of this clinical trial is to evaluate guideline-directed medical therapy (GDMT) up-titration in patients with heart failure with reduced ejection fraction.The main question it aims to answer is the improvement in prescription rate and dose uptitration of quadruple GDMT in patients with HFrEF, assessed by a weighed composite score.
Participants will be randomized towards control (standard of care, SOC) or intervention group.
Researchers will compare SOC with protocol-based up-titration to see if the protocolized optimization improves prescription rate of GDMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized-controlled trial. Due to the design, the study is open-label, but the endpoint assessment is blinded.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Procedure: SOCUp-titration of GDMT at the discretion of the treating physician. |
| Intervention | Experimental | Procedure: Protocolized up-titrationUptitration of GDMT according to the renal-based approach postulated by the Heart Failure Association of the European Society of Cardiology (HFA-ESC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Left ventricular ejection fraction ≤ 40%, assessed LVEF with imaging within last three months before randomization (TTE/KT/MIBI/MRI)
- NYHA ≥ II
Key exclusion criteria (9 listed)
- Hemodynamic instability
- Recent acute coronary syndrome (< 1 month before randomisation)
- Already on quadruple heart failure therapy or on triple GDMT in case of eGFR < 30ml/min/1.73m2 or a potassium above 6mmol/L
- eGFR < 20ml/min/1.73², planned for dialysis or already actively treated with chronic dialysis.
- Implantation of a cardiac resynchronization therapy (CRT) within 3 months
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 |
|---|---|---|
| SOCPhysician-guided GDMT up-titration | Procedure or surgery | Standard of Care |
| Protocolized up-titrationRenal-based protocolized GDMT up-titration | Procedure or surgery | Intervention |
Primary outcome
Weighed composite score of maximal guideline-directed medical therapy
Time frame: 3 months
The composite score of maximal guideline-directed medical therapy 3 months after inclusion.(minimum score 0, maximum score 15)
3 secondary outcomes
All-cause mortality and heart failure hospitalizations
Time frame: 3 months
Change in NTproBNP
Time frame: 3 months
Change in renal function
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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. This study is not recruiting at the moment.
Wilfried Mullens principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOC and Protocolized up-titration in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weighed composite score of maximal guideline-directed medical therapy (time frame: 3 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 28 Feb 2024.