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SGLT2 Inhibitor

balcinrenone/dapagliflozin 40 mg/10 mg for Cardio-Renal Syndrome (BalanceD-HF Trial)

Phase 3

Waitlist Available

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

BalanceD-HF Trial 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.Check my eligibility

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).See study design

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.

BalanceD-HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 38 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation

Secondary outcome measures

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

BalanceD-HF 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,272 Previous Clinical Trials

288,607,875 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many diverse venues is this experimental examination currently being conducted?

"At the moment, patient enrollment is ongoing at 375 diverse sites. These sites are spread across various locations such as Maumee, Alexander City, and Providence among numerous others. Opting for a site close to your residence would be advantageous in reducing travel requirements during your potential participation."

Answered by AI

Are individuals above the age of 40 eligible to participate in this medical study?

"The age range for participation in this research is set between 18 and 130 years old."

Answered by AI

Are potential participants currently able to apply for enrollment in this ongoing clinical trial?

"As per the information available on clinicaltrials.gov, recruitment for this research is currently closed. The trial was initially listed on April 12, 2024, and last revised on March 6, 2024. While this specific study is not open for enrollment at present, it's worth noting that there are a substantial number of other trials actively seeking participants – to be exact, a total of 761 trials are open for patient recruitment presently."

Answered by AI

Do I meet the necessary requirements to participate in this clinical study?

"To be eligible for enrollment, participants must present with cardio-renal syndrome and fall within the age bracket of 18 to 130 years. The trial aims to recruit approximately 4800 individuals meeting these criteria."

Answered by AI

Has the combination drug balcinrenone/dapagliflozin 15 mg/10 mg been given clearance by the FDA for use?

"The safety rating for the combination of balcinrenone and dapagliflozin at doses of 15 mg and 10 mg, respectively, was rated as a three by our team due to its Phase III status. This indicates that there is existing evidence supporting both effectiveness and safety garnered from various data collection efforts."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

2024. "Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06307652.