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

Heart Failure Clinical Trial

— ReQUAD-HF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06273280
• Other study ID #: Z-2023025
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 14, 2024
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: Ziekenhuis Oost-Limburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 345
• Est. completion date: March 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Procedure:
• SOC
Physician-guided GDMT up-titration
• Protocolized up-titration
Renal-based protocolized GDMT up-titration

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg AV	Genk	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg	King Baudouin Foundation

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All-cause mortality	All-cause mortality after 3 months	3 months
Other	Number of patients with heart failure hospitalizations	Heart failure hospitalizations after 3 months	3 months
Other	Change in prescription rate per GDMT class	Uptitration per class of GDMT.	3 months
Other	Incidence of predefined safety endpoints	Prespecified safety events (renal function, potassium, hypotension and bradycardia)	3 months
Primary	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)	3 months
Secondary	All-cause mortality and heart failure hospitalizations	All-cause mortality and heart failure hospitalization after three months of follow-up	3 months
Secondary	Change in NTproBNP	Change in NT-proBNP over 3 months	3 months
Secondary	Change in renal function	Change in eGFR, calculated with the CKD-EPI formula	3 months