NCT06307652ClinicalTrials.gov

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

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

RecruitingTaking participants now, according to the registry record.

Contact this study

In brief

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…

Phase 33,850 participants sought852 sites39 countries

Registered in 1 registry

ClinicalTrials.govNCT06307652Open this record at ClinicalTrials.govSynced last week

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

Interested in this study?

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2024-03-13; recorded start 2024-04-12
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 852 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 3,850 participants (target), run at 852 sites, across 39 countries.

How this score is built

Enrolment36/40
4,800 participants (target)
Site count25/25
852 sites
Country count15/15
39 countries
Planned duration8/10
Planned over about 39 months
Sponsor scale10/10
AstraZeneca has led 991 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

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 will be conducted at approximately 700 sites in approximately 40 countries globally.

Conditions

Heart Failure and Impaired Kidney Function

Eligibility

Eligibility
Sex	All
Ages	18 Years – 130 Years
Healthy volunteers	No

Eligibility as written in the registry

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 ≤ 5.0 mmol/L Exclusion Criteria: * Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period * 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 during the screening period, 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 \< 90 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 * Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy * 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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 3
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	QUADRUPLE (4)
Enrolment	3,850 participants sought

Sponsor and collaborators

AstraZeneca Sponsor

Arms and interventions

balcinrenone/dapagliflozin 15 mg/10 mgEXPERIMENTAL
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
balcinrenone/dapagliflozin 40 mg/10 mgEXPERIMENTAL
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
dapagliflozin 10 mgACTIVE_COMPARATOR
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

Interventions

Drug balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
Drug balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
Drug dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin
1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use

Outcome measures

Primary outcome
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
Time frame Approximately 36 months
Secondary outcome
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
Time frame Approximately 36 months
Secondary outcome
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
Time frame Approximately 36 months
Secondary outcome
Time to CV death
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death
Time frame Approximately 36 months
Secondary outcome
Time to death from any cause
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause
Time frame Approximately 36 months
Secondary outcome
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
Time frame Approximately 24 weeks

Dates

Dates
Start date	April 12, 2024 (actual)
Primary completion	April 16, 2027 (estimated)
Completion	April 16, 2027 (estimated)
First posted	March 13, 2024 (actual)
Last updated	September 11, 2026
Results posted	Not stated in the registry record
Status last verified	September 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

631 sites are recruiting

Argentina

Argentina
Facility	City	Status
Research Site	Buenos Aires	Recruiting
Research Site	Buenos Aires	Recruiting
Research Site	Buenos Aires	Recruiting
Research Site	CABA	Recruiting
Research Site	Ciudad de Buenos Aires	Recruiting
Research Site	Ciudad de Buenos Aires	Recruiting
Research Site	Corrientes	Recruiting
Research Site	Córdoba	Recruiting
Research Site	Córdoba	Recruiting
Research Site	Esperanza	Recruiting
Research Site	Granadero Baigorria	Recruiting
Research Site	Mar del Plata	Recruiting
Research Site	Rosario	Recruiting
Research Site	San Juan Bautista	Recruiting
Research Site	San Miguel de Tucumán	Recruiting
Research Site	San Miguel de Tucumán	Withdrawn
Research Site	San Miguel de Tucumán	Recruiting
Research Site	Santa Fe	Recruiting

Australia

Australia
Facility	City	Status
Research Site	Blacktown	Recruiting
Research Site	Cairns	Withdrawn
Research Site	Canberra	Recruiting
Research Site	Chermside	Withdrawn
Research Site	Clayton	Recruiting
Research Site	Concord	Recruiting
Research Site	Frankston	Recruiting
Research Site	Geelong	Recruiting
Research Site	Murdoch	Recruiting
Research Site	North Tamworth	Recruiting
Research Site	Westmead	Recruiting

Austria

Austria
Facility	City	Status
Research Site	Bad Ischl	Recruiting
Research Site	Braunau am Inn	Recruiting
Research Site	Graz	Recruiting
Research Site	Linz	Recruiting
Research Site	Saint Stefan/Stainz	Recruiting
Research Site	Salzburg	Recruiting
Research Site	Sankt Pölten	Recruiting
Research Site	Vienna	Recruiting
Research Site	Vienna	Recruiting
Research Site	Vienna	Recruiting
Research Site	Vöcklabruck	Recruiting

Brazil

Brazil
Facility	City	Status
Research Site	Aracaju	Recruiting
Research Site	Blumenau	Recruiting
Research Site	Brasília	Recruiting
Research Site	Campina Grande do Sul	Recruiting
Research Site	Campinas	Recruiting
Research Site	Curitiba	Recruiting
Research Site	Goiânia	Recruiting
Research Site	Niterói	Withdrawn
Research Site	Porto Alegre	Recruiting
Research Site	Rio Branco	Recruiting

802 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

September 11, 2026
Completion date moved earlier
Primary completion advanced 56 days
2027-06-112027-04-16
September 11, 2026
Enrolment target changed
Enrollment target revised down from 4800 to 3850
48003850

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06307652

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Argentina

Australia

Austria

Brazil

Study documents

Changes over time