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

NCT06273280 | Active Not Recruiting DMC

• 1 other identifier: Z-2023025
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Heart Failure With Reduced Ejection Fraction

Keywords

heart failure; heart failure with reduced ejection fraction; guideline-directed medical therapy; quadruple therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• All-cause mortality and heart failure hospitalizations

  3 months

• Change in NTproBNP

  3 months

• Change in renal function

  3 months

Other Outcomes (4)

• All-cause mortality

  3 months

• Number of patients with heart failure hospitalizations

  3 months

• Change in prescription rate per GDMT class

  3 months

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

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)

Procedure: Protocolized up-titration

Interventions

SOC PROCEDURE

Physician-guided GDMT up-titration

Standard of Care

Protocolized up-titration PROCEDURE

Renal-based protocolized GDMT up-titration

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead
• King Baudouin Foundation: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg AV

Genk, Limburg, 3600, Belgium

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Wilfried Mullens

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the study design, the study is open-label. In order to reduce bias, a study nurse (blinded for allocation arm) will see or call the patient to register the heart failure medication and dose of loop diuretics at three months and optionally 12months (open-label, endpoint-blinded).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized-controlled trial. Due to the design, the study is open-label, but the endpoint assessment is blinded.

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 22, 2024
• Study Start: February 14, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

BE (1)