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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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En resumen

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…

Fase 33850 participantes buscados852 centros39 países

Categorías

Cardiovascular68%Nefrología y urología32%

Registrado en 1 registro

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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.

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

Resumen

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.

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.

Afecciones

  • Heart Failure and Impaired Kidney Function

Elegibilidad

SexoTodos
Edades18 Years – 130 Years
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoQUADRUPLE (4)
Inscripción3850 participantes buscados

Patrocinador y colaboradores

  • AstraZeneca Patrocinador

Grupos e intervenciones

  • 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

Intervenciones

  • Fármaco 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

  • Fármaco 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

  • Fármaco 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

Variables de resultado

  1. Variable de resultado principal

    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

    Plazo Approximately 36 months

  2. Variable de resultado secundaria

    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

    Plazo Approximately 36 months

  3. Variable de resultado secundaria

    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

    Plazo Approximately 36 months

  4. Variable de resultado secundaria

    Time to CV death

    To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death

    Plazo Approximately 36 months

  5. Variable de resultado secundaria

    Time to death from any cause

    To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause

    Plazo Approximately 36 months

  6. Variable de resultado secundaria

    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

    Plazo Approximately 24 weeks

Fechas

Fecha de inicio12 de abril de 2024 (real)
Finalización principal16 de abril de 2027 (estimada)
Finalización16 de abril de 2027 (estimada)
Primera publicación13 de marzo de 2024 (real)
Última actualización11 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezseptiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

631 centros están en reclutamiento

Argentina

CentroCiudadEstado o regiónEstado
Research SiteBuenos AiresEn reclutamiento
Research SiteBuenos AiresEn reclutamiento
Research SiteBuenos AiresEn reclutamiento
Research SiteCABAEn reclutamiento
Research SiteCiudad de Buenos AiresEn reclutamiento
Research SiteCiudad de Buenos AiresEn reclutamiento
Research SiteCorrientesEn reclutamiento
Research SiteCórdobaEn reclutamiento
Research SiteCórdobaEn reclutamiento
Research SiteEsperanzaEn reclutamiento
Research SiteGranadero BaigorriaEn reclutamiento
Research SiteMar del PlataEn reclutamiento
Research SiteRosarioEn reclutamiento
Research SiteSan Juan BautistaEn reclutamiento
Research SiteSan Miguel de TucumánEn reclutamiento
Research SiteSan Miguel de TucumánRetirado
Research SiteSan Miguel de TucumánEn reclutamiento
Research SiteSanta FeEn reclutamiento

Australia

CentroCiudadEstado o regiónEstado
Research SiteBlacktownEn reclutamiento
Research SiteCairnsRetirado
Research SiteCanberraEn reclutamiento
Research SiteChermsideRetirado
Research SiteClaytonEn reclutamiento
Research SiteConcordEn reclutamiento
Research SiteFrankstonEn reclutamiento
Research SiteGeelongEn reclutamiento
Research SiteMurdochEn reclutamiento
Research SiteNorth TamworthEn reclutamiento
Research SiteWestmeadEn reclutamiento

Austria

CentroCiudadEstado o regiónEstado
Research SiteBad IschlEn reclutamiento
Research SiteBraunau am InnEn reclutamiento
Research SiteGrazEn reclutamiento
Research SiteLinzEn reclutamiento
Research SiteSaint Stefan/StainzEn reclutamiento
Research SiteSalzburgEn reclutamiento
Research SiteSankt PöltenEn reclutamiento
Research SiteViennaEn reclutamiento
Research SiteViennaEn reclutamiento
Research SiteViennaEn reclutamiento
Research SiteVöcklabruckEn reclutamiento

Brazil

CentroCiudadEstado o regiónEstado
Research SiteAracajuEn reclutamiento
Research SiteBlumenauEn reclutamiento
Research SiteBrasíliaEn reclutamiento
Research SiteCampina Grande do SulEn reclutamiento
Research SiteCampinasEn reclutamiento
Research SiteCuritibaEn reclutamiento
Research SiteGoiâniaEn reclutamiento
Research SiteNiteróiRetirado
Research SitePorto AlegreEn reclutamiento
Research SiteRio BrancoEn reclutamiento

En el registro figuran 802 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 11 de septiembre de 2026

    Fecha de finalización adelantada

    Primary completion advanced 56 days

    2027-06-112027-04-16

  2. 11 de septiembre de 2026

    Objetivo de inscripción modificado

    Enrollment target revised down from 4800 to 3850

    48003850

Registro: ClinicalTrials.gov · NCT########

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