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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
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En bref

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 recherchés852 sites39 pays

Catégories

Cardiovasculaire68%Néphrologie et urologie32%

Enregistré dans 1 registre

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Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Heart Failure and Impaired Kidney Function

Éligibilité

SexeTous
Âges18 Years – 130 Years
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuQUADRUPLE (4)
Recrutement3 850 participants recherchés

Promoteur et collaborateurs

  • AstraZeneca Promoteur

Groupes et 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

  • Médicament 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

  • Médicament 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

  • Médicament 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

Critères de jugement

  1. Critère de jugement 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

    Délai Approximately 36 months

  2. Critère de jugement secondaire

    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

    Délai Approximately 36 months

  3. Critère de jugement secondaire

    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

    Délai Approximately 36 months

  4. Critère de jugement secondaire

    Time to CV death

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

    Délai Approximately 36 months

  5. Critère de jugement secondaire

    Time to death from any cause

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

    Délai Approximately 36 months

  6. Critère de jugement secondaire

    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

    Délai Approximately 24 weeks

Dates

Date de début12 avril 2024 (réelle)
Achèvement principal16 avril 2027 (estimée)
Achèvement16 avril 2027 (estimée)
Première publication13 mars 2024 (réelle)
Dernière mise à jour11 septembre 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisseptembre 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

631 sites sont en recrutement

Argentina

ÉtablissementVilleÉtat ou régionStatut
Research SiteBuenos AiresEn recrutement
Research SiteBuenos AiresEn recrutement
Research SiteBuenos AiresEn recrutement
Research SiteCABAEn recrutement
Research SiteCiudad de Buenos AiresEn recrutement
Research SiteCiudad de Buenos AiresEn recrutement
Research SiteCorrientesEn recrutement
Research SiteCórdobaEn recrutement
Research SiteCórdobaEn recrutement
Research SiteEsperanzaEn recrutement
Research SiteGranadero BaigorriaEn recrutement
Research SiteMar del PlataEn recrutement
Research SiteRosarioEn recrutement
Research SiteSan Juan BautistaEn recrutement
Research SiteSan Miguel de TucumánEn recrutement
Research SiteSan Miguel de TucumánRetiré
Research SiteSan Miguel de TucumánEn recrutement
Research SiteSanta FeEn recrutement

Australia

ÉtablissementVilleÉtat ou régionStatut
Research SiteBlacktownEn recrutement
Research SiteCairnsRetiré
Research SiteCanberraEn recrutement
Research SiteChermsideRetiré
Research SiteClaytonEn recrutement
Research SiteConcordEn recrutement
Research SiteFrankstonEn recrutement
Research SiteGeelongEn recrutement
Research SiteMurdochEn recrutement
Research SiteNorth TamworthEn recrutement
Research SiteWestmeadEn recrutement

Austria

ÉtablissementVilleÉtat ou régionStatut
Research SiteBad IschlEn recrutement
Research SiteBraunau am InnEn recrutement
Research SiteGrazEn recrutement
Research SiteLinzEn recrutement
Research SiteSaint Stefan/StainzEn recrutement
Research SiteSalzburgEn recrutement
Research SiteSankt PöltenEn recrutement
Research SiteViennaEn recrutement
Research SiteViennaEn recrutement
Research SiteViennaEn recrutement
Research SiteVöcklabruckEn recrutement

Brazil

ÉtablissementVilleÉtat ou régionStatut
Research SiteAracajuEn recrutement
Research SiteBlumenauEn recrutement
Research SiteBrasíliaEn recrutement
Research SiteCampina Grande do SulEn recrutement
Research SiteCampinasEn recrutement
Research SiteCuritibaEn recrutement
Research SiteGoiâniaEn recrutement
Research SiteNiteróiRetiré
Research SitePorto AlegreEn recrutement
Research SiteRio BrancoEn recrutement

802 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 11 septembre 2026

    Date d'achèvement avancée

    Primary completion advanced 56 days

    2027-06-112027-04-16

  2. 11 septembre 2026

    Objectif de recrutement modifié

    Enrollment target revised down from 4800 to 3850

    48003850

Registre: ClinicalTrials.gov · NCT########

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