Informations générales (source: ClinicalTrials.gov)
A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function (BalanceD-HF)
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
avril 2024
juin 2027
15 mai 2025
This is a Phase III, international, multi-centre, randomised, double-blind,
parallel-group, double-dummy, active-controlled, event-driven study in patients with
chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate
the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of
other classes of SoC, on CV death and HF events.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Research Site - 14033 - Caen - France | Contact (sur clinicalTrials) | ||||
| Research Site - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 28630 - Le Coudray - France | Contact (sur clinicalTrials) | ||||
| Research Site - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Research Site - 34000 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Research Site - 34295 - Montpellier Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 34500 - Beziers - France | Contact (sur clinicalTrials) | ||||
| Research Site - 35033 - Rennes Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 37044 - TOURS Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 38043 - La Tronche - France | Contact (sur clinicalTrials) | ||||
| Research Site - 44093 - Nantes cedex 1 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 45100 - Orleans - France | Contact (sur clinicalTrials) | ||||
| Research Site - 51092 - Reims - France | Contact (sur clinicalTrials) | ||||
| Research Site - 59300 - Valenciennes - France | Contact (sur clinicalTrials) | ||||
| Research Site - 67091 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Research Site - 69667 - Bron - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75015 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 76031 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Research Site - 82017 - Montauban - France | Contact (sur clinicalTrials) | ||||
| Research Site - 83100 - Toulon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 85925 - La Roche Sur Yon Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 86021 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Research Site - 87000 - Limoges - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94010 - Creteil - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Age ≥ 18 years
- Documented diagnosis of symptomatic HF (NYHA functional class II-IV)
- Having had a recent HF event within 6 months (hospitalization or urgent visit)
- Have a LVEF value from an assessment within the last 12 months
- Managed with SoC therapy for HF and renal impairment according to local guidelines
- NT-proBNP must be >300 pg/mL (>600 pg/mL if concomitant atrial fibrillation or
atrial flutter)
- Not taking an MRA
- An eGFR ≥ 20 to < 60 mL/min/1.73 m2
- Serum/plasma potassium ≥ 3.5 mmol/L and ≤ 5.0 mmol/L
- Age ≥ 18 years
- Documented diagnosis of symptomatic HF (NYHA functional class II-IV)
- Having had a recent HF event within 6 months (hospitalization or urgent visit)
- Have a LVEF value from an assessment within the last 12 months
- Managed with SoC therapy for HF and renal impairment according to local guidelines
- NT-proBNP must be >300 pg/mL (>600 pg/mL if concomitant atrial fibrillation or
atrial flutter)
- Not taking an MRA
- An eGFR ≥ 20 to < 60 mL/min/1.73 m2
- Serum/plasma potassium ≥ 3.5 mmol/L and ≤ 5.0 mmol/L
- Acute coronary syndrome (unstable angina or myocardial infarction), stroke or
transient ischaemic attack within the previous 3 months
- Major cardiac surgery, coronary revascularisation or valvular repair or replacement,
or implantation of a Cardiac resynchronisation therapy device within 3 months prior
to enrolment or planned to undergo any of these operations
- History of hypertrophic obstructive cardiomyopathy
- Complex congenital heart disease or severe uncorrected primary valvular disease
- Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
- Systolic BP < 100 mmHg, or symptomatic hypotension within the past 24 hours
- Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease
including COPD or exacerbation of COPD requiring invasive mechanical ventilation
assistance within 12 months prior to enrolment
- Type 1 diabetes mellitus
- Kidney replacement therapy in the past 4 weeks, currently requiring kidney
replacement or imminent plan to start kidney replacement therapy
- Hepatic disease, including active HBV or HCV infection, or other cause of hepatitis,
and/or hepatic impairment (Child-Pugh class A-C), AST or ALT >3 × ULN; or TBL > 2 ×
ULN at time of screening
- Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation
for COVID-19 within the last 12 weeks
- Treatment with strong or moderate CYP3A4 inhibitor or inducer