Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| King Baudouin Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Up-titration of GDMT at the discretion of the treating physician. |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOC | Procedure | Physician-guided GDMT up-titration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality and heart failure hospitalizations | All-cause mortality and heart failure hospitalization after three months of follow-up | 3 months |
| Change in NTproBNP | Change in NT-proBNP over 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality after 3 months | 3 months |
| Number of patients with heart failure hospitalizations | Heart failure hospitalizations after 3 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wilfried Mullens | Ziekenhuis Oost-Limburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg AV | Genk | Limburg | 3600 | Belgium |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
This is a prospective, randomized-controlled trial. Due to the design, the study is open-label, but the endpoint assessment is blinded.
Not provided
Not provided
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).
| Protocolized up-titration |
| Procedure |
Renal-based protocolized GDMT up-titration |
|
| 3 months |
| Change in renal function | Change in eGFR, calculated with the CKD-EPI formula | 3 months |
| 3 months |
| Change in prescription rate per GDMT class | Uptitration per class of GDMT. | 3 months |
| Incidence of predefined safety endpoints | Prespecified safety events (renal function, potassium, hypotension and bradycardia) | 3 months |