Clinical trial NCT06273280: Renal-based Optimization of QUADruple Therapy in Patients With Heart Failure With Reduced Ejection Fraction.
Official title: Renal-based Optimization of QUADruple Therapy in Patients With Heart Failure With Reduced Ejection Fraction: a Prospective, Multicentre, International Randomized Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Heart Failure With Reduced Ejection Fraction
Keywords: heart failure
heart failure with reduced ejection fraction
guideline-directed medical therapy
quadruple therapy
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
Collaborators: name: King Baudouin Foundation
First posted: 2024-02-22
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized-controlled trial. Due to the design, the study is open-label, but the endpoint assessment is blinded.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Weighed composite score of maximal guideline-directed medical therapy
timeFrame: 3 months
Secondary outcomes:
measure: All-cause mortality and heart failure hospitalizations
timeFrame: 3 months
measure: Change in NTproBNP
timeFrame: 3 months
measure: Change in renal function
timeFrame: 3 months
Other outcomes:
measure: All-cause mortality
timeFrame: 3 months
measure: Number of patients with heart failure hospitalizations
timeFrame: 3 months
measure: Change in prescription rate per GDMT class
timeFrame: 3 months
measure: Incidence of predefined safety endpoints
timeFrame: 3 months
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg AV
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Wilfried Mullens
role: PRINCIPAL_INVESTIGATOR
References: