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

February 23, 2024 updated by: Ziekenhuis Oost-Limburg

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

345

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Ziekenhuis Oost-Limburg AV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
Up-titration of GDMT at the discretion of the treating physician.
Procedure: SOC
Physician-guided GDMT up-titration
Experimental: Intervention
Uptitration of GDMT according to the renal-based approach postulated by the Heart Failure Association of the European Society of Cardiology (HFA-ESC)
Procedure: Protocolized up-titration
Renal-based protocolized GDMT up-titration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality and heart failure hospitalizations
Time Frame: 3 months
All-cause mortality and heart failure hospitalization after three months of follow-up
3 months
Change in NTproBNP
Time Frame: 3 months
Change in NT-proBNP over 3 months
3 months
Change in renal function
Time Frame: 3 months
Change in eGFR, calculated with the CKD-EPI formula
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 3 months
All-cause mortality after 3 months
3 months
Number of patients with heart failure hospitalizations
Time Frame: 3 months
Heart failure hospitalizations after 3 months
3 months
Change in prescription rate per GDMT class
Time Frame: 3 months
Uptitration per class of GDMT.
3 months
Incidence of predefined safety endpoints
Time Frame: 3 months
Prespecified safety events (renal function, potassium, hypotension and bradycardia)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziekenhuis Oost-Limburg

Collaborators

King Baudouin Foundation

Investigators

  • Principal Investigator: Wilfried Mullens, Ziekenhuis Oost-Limburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 22, 2024

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z-2023025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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