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

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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 Teilnehmende gesucht852 Studienzentren39 Länder

Kategorien

Herz-Kreislauf68%Nephrologie und Urologie32%

In 1 Register registriert

ClinicalTrials.govNCT06307652Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert letzte Woche

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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.

Zusammenfassung

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.

Erkrankungen

Heart Failure and Impaired Kidney Function

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – 130 Years
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 3
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	QUADRUPLE (4)
Teilnahme	3.850 Teilnehmende gesucht

Sponsor und Mitwirkende

AstraZeneca Sponsor

Studienarme und Interventionen

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

Interventionen

Arzneimittel 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
Arzneimittel 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
Arzneimittel 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

Endpunkte

Primärer Endpunkt
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
Zeitrahmen Approximately 36 months
Sekundärer Endpunkt
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
Zeitrahmen Approximately 36 months
Sekundärer Endpunkt
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
Zeitrahmen Approximately 36 months
Sekundärer Endpunkt
Time to CV death
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death
Zeitrahmen Approximately 36 months
Sekundärer Endpunkt
Time to death from any cause
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause
Zeitrahmen Approximately 36 months
Sekundärer Endpunkt
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
Zeitrahmen Approximately 24 weeks

Daten

Daten
Startdatum	12. April 2024 (tatsächlich)
Primärer Abschluss	16. April 2027 (geschätzt)
Abschluss	16. April 2027 (geschätzt)
Erstveröffentlichung	13. März 2024 (tatsächlich)
Zuletzt aktualisiert	11. September 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	September 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

631 Studienzentren rekrutieren

Argentina

Argentina
Einrichtung	Stadt	Status
Research Site	Buenos Aires	Rekrutiert
Research Site	Buenos Aires	Rekrutiert
Research Site	Buenos Aires	Rekrutiert
Research Site	CABA	Rekrutiert
Research Site	Ciudad de Buenos Aires	Rekrutiert
Research Site	Ciudad de Buenos Aires	Rekrutiert
Research Site	Corrientes	Rekrutiert
Research Site	Córdoba	Rekrutiert
Research Site	Córdoba	Rekrutiert
Research Site	Esperanza	Rekrutiert
Research Site	Granadero Baigorria	Rekrutiert
Research Site	Mar del Plata	Rekrutiert
Research Site	Rosario	Rekrutiert
Research Site	San Juan Bautista	Rekrutiert
Research Site	San Miguel de Tucumán	Rekrutiert
Research Site	San Miguel de Tucumán	Zurückgezogen
Research Site	San Miguel de Tucumán	Rekrutiert
Research Site	Santa Fe	Rekrutiert

Australia

Australia
Einrichtung	Stadt	Status
Research Site	Blacktown	Rekrutiert
Research Site	Cairns	Zurückgezogen
Research Site	Canberra	Rekrutiert
Research Site	Chermside	Zurückgezogen
Research Site	Clayton	Rekrutiert
Research Site	Concord	Rekrutiert
Research Site	Frankston	Rekrutiert
Research Site	Geelong	Rekrutiert
Research Site	Murdoch	Rekrutiert
Research Site	North Tamworth	Rekrutiert
Research Site	Westmead	Rekrutiert

Austria

Austria
Einrichtung	Stadt	Status
Research Site	Bad Ischl	Rekrutiert
Research Site	Braunau am Inn	Rekrutiert
Research Site	Graz	Rekrutiert
Research Site	Linz	Rekrutiert
Research Site	Saint Stefan/Stainz	Rekrutiert
Research Site	Salzburg	Rekrutiert
Research Site	Sankt Pölten	Rekrutiert
Research Site	Vienna	Rekrutiert
Research Site	Vienna	Rekrutiert
Research Site	Vienna	Rekrutiert
Research Site	Vöcklabruck	Rekrutiert

Brazil

Brazil
Einrichtung	Stadt	Status
Research Site	Aracaju	Rekrutiert
Research Site	Blumenau	Rekrutiert
Research Site	Brasília	Rekrutiert
Research Site	Campina Grande do Sul	Rekrutiert
Research Site	Campinas	Rekrutiert
Research Site	Curitiba	Rekrutiert
Research Site	Goiânia	Rekrutiert
Research Site	Niterói	Zurückgezogen
Research Site	Porto Alegre	Rekrutiert
Research Site	Rio Branco	Rekrutiert

802 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

11. September 2026
Abschlussdatum nach vorne verschoben
Primary completion advanced 56 days
2027-06-112027-04-16
11. September 2026
Teilnahmeziel geändert
Enrollment target revised down from 4800 to 3850
48003850

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