Renal-based Optimization of QUADruple Therapy in Patients With Heart Failure With Reduced Ejection Fraction. (ReQUAD-HF)

East Limburg Hospital

Status: Active, not recruiting

Conditions: Heart Failure With Reduced Ejection Fraction; Heart Failure

Treatments: Procedure: Protocolized up-titration; Procedure: SOC

Study type: Interventional

Funder types: Other

Identifiers

NCT06273280

Z-2023025

Details and patient eligibility

About

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.

Enrollment: 345 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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345 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

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

Treatment:

Procedure: SOC

Intervention

Experimental group

Description:

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

Treatment:

Procedure: Protocolized up-titration