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SGLT2 Inhibitor

Balcinrenone + Dapagliflozin for Heart Failure (BalanceD-HF Trial)

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 38 months
Awards & highlights

Summary

This trial aims to study the effects of a new medication, balcinrenone/dapagliflozin, compared to an existing medication, dapagliflozin, in patients with

Who is the study for?
This trial is for patients with chronic heart failure and poor kidney function who recently had a heart-related event. Participants should be on standard-of-care treatments for their condition. Specific eligibility details are not provided, but typically, trials exclude individuals with conditions or circumstances that could interfere with the study's outcomes.
What is being tested?
The study tests the effects of combining balcinrenone/dapagliflozin at two different doses versus dapagliflozin alone in managing heart failure. It's a Phase III trial where participants are randomly assigned to one of the treatment groups and neither they nor the researchers know who gets which treatment (double-blind).
What are the potential side effects?
While specific side effects aren't listed here, drugs like balcinrenone/dapagliflozin can cause issues such as dehydration, low blood pressure, kidney problems, high potassium levels, and possible allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 38 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 38 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation
Secondary study objectives
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
Time to CV death
Time to death from any cause
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: balcinrenone/dapagliflozin 40 mg/10 mgExperimental Treatment1 Intervention
Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Group II: balcinrenone/dapagliflozin 15 mg/10 mgExperimental Treatment1 Intervention
Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Group III: dapagliflozin 10 mgActive Control1 Intervention
Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,352 Previous Clinical Trials
288,642,009 Total Patients Enrolled
~3200 spots leftby Jun 2027
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