Heart Failure, Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
heart failure, heart failure with reduced ejection fraction, guideline-directed medical therapy, quadruple therapy
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.
Interventions
PROCEDURESOC
Physician-guided GDMT up-titration
PROCEDUREProtocolized up-titration
Renal-based protocolized GDMT up-titration
Sponsors
King Baudouin Foundation
Ziekenhuis Oost-Limburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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).
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weighed composite score of maximal guideline-directed medical therapy | 3 months | The composite score of maximal guideline-directed medical therapy 3 months after inclusion.(minimum score 0, maximum score 15) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality and heart failure hospitalizations | 3 months | All-cause mortality and heart failure hospitalization after three months of follow-up |
| Change in NTproBNP | 3 months | Change in NT-proBNP over 3 months |
| Change in renal function | 3 months | Change in eGFR, calculated with the CKD-EPI formula |
Other
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 3 months | All-cause mortality after 3 months |
| Number of patients with heart failure hospitalizations | 3 months | Heart failure hospitalizations after 3 months |
| Change in prescription rate per GDMT class | 3 months | Uptitration per class of GDMT. |
| Incidence of predefined safety endpoints | 3 months | Prespecified safety events (renal function, potassium, hypotension and bradycardia) |
Countries
Belgium
Outcome results
None listed