Suspended

ReQUAD-HFProtocol-based Optimization of Quadruple Therapy for Heart Failure with Reduced Ejection Fraction

Study Aim

This study aims to optimize the treatment for heart failure with reduced ejection fraction using a protocol-based approach for quadruple therapy, with the primary outcome being a composite score of maximal guideline-directed medical therapy 3 months after your participation.

What is being tested

SOC

+ Protocolized up-titration

Procedure

Who is being recruted

Cardiovascular Diseases

+ Heart Diseases

+ Heart Failure

Over 18 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: February 2024

See protocol details

Summary

Principal SponsorZiekenhuis Oost-Limburg

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 14, 2024

Actual date on which the first participant was enrolled.

This clinical trial focuses on patients suffering from heart failure with reduced ejection fraction, a condition where the heart does not pump blood as effectively as it should. The study aims to see if adjusting and increasing the doses of a combination of four specific heart medications, following medical guidelines, can enhance treatment outcomes. By doing so, researchers hope to improve the way these medications are prescribed and adjusted, which can lead to better management and quality of life for patients with this type of heart failure. Participants in the trial will be divided into two groups. One group will continue with the standard care they are already receiving, while the other group will follow a specific plan to increase the doses of their heart medications. The study will compare these two approaches to determine if the planned medication adjustments lead to a better prescription rate. The effectiveness of the treatment adjustments will be assessed using a special score that takes into account various health factors related to heart failure. The goal is to find out if the detailed plan for increasing medication doses can lead to improved heart health outcomes.

Official TitleRenal-based Optimization of QUADruple Therapy in Patients With Heart Failure With Reduced Ejection Fraction: a Prospective, Multicentre, International Randomized Study

NCT06273280

Principal SponsorZiekenhuis Oost-Limburg

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

345 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart Failure

Criteria

2 inclusion criteria required to participate

Left ventricular ejection fraction ≤ 40%, assessed LVEF with imaging within last three months before randomization (TTE/KT/MIBI/MRI)

NYHA ≥ II

9 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Up-titration of GDMT at the discretion of the treating physician.

Group II

Experimental

Uptitration of GDMT according to the renal-based approach postulated by the Heart Failure Association of the European Society of Cardiology (HFA-ESC)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Ziekenhuis Oost-Limburg AV

Genk, BelgiumOpen Ziekenhuis Oost-Limburg AV in Google Maps

SuspendedOne Study Center