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Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
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.
Study details:
The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments:. 1.
Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet. 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet.
3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule. The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin.
The study will be conducted at approximately 700 sites in approximately 40 countries globally.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-04-12
Primary completion: 2027-06-11
Study completion finish: 2027-06-11
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06307652
Intervention or treatment
DRUG: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
DRUG: balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
DRUG: dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin
Conditions
- • Heart Failure and Impaired Kidney Function
Find a site
Closest Location:
Research Site
Research sites nearby
Select from list below to view details:
Research Site
Canberra, Not Specified, Australia
Research Site
Chermside, Not Specified, Australia
Research Site
Clayton, Not Specified, Australia
Research Site
Concord, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: balcinrenone/dapagliflozin 15 mg/10 mg
| DRUG: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
|
EXPERIMENTAL: balcinrenone/dapagliflozin 40 mg/10 mg
| DRUG: balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
|
ACTIVE_COMPARATOR: dapagliflozin 10 mg
| DRUG: dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation | To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death and HF events with and without hospitalisation | Approximately 38 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation | To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the rate of total occurrences of CV death, and HF events with and without hospitalisation | Approximately 38 months |
Total occurrences (first and recurrent) of HF hospitalisations | To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the rate of total HF hospitalisations | Approximately 38 months |
Time to CV death | To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death | Approximately 38 months |
The hierarchical composite endpoint of death from any cause, total HF events, and change from baseline in KCCQ total symptom score to 24-week post-randomisation | To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause, HF events, and improving patient reported symptoms of HF | Approximately 24 weeks |
Time to death from any cause | To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause | Approximately 38 months |
Frequently Asked Questions
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