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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-14

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure Heart Failure With Reduced Ejection Fraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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).

Study Groups

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Standard of Care

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

Group Type ACTIVE_COMPARATOR

SOC

Intervention Type PROCEDURE

Physician-guided GDMT up-titration

Intervention

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

Group Type EXPERIMENTAL

Protocolized up-titration

Intervention Type PROCEDURE

Renal-based protocolized GDMT up-titration

Interventions

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SOC

Physician-guided GDMT up-titration

Intervention Type PROCEDURE

Protocolized up-titration

Renal-based protocolized GDMT up-titration

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No