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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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In breve

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 partecipanti ricercati852 centri39 paesi

Categorie

Cardiovascolare68%Nefrologia e urologia32%

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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.

Sintesi

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.

Patologie

  • Heart Failure and Impaired Kidney Function

Idoneità

SessoTutti
Età18 Years – 130 Years
Volontari saniNo

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoQUADRUPLE (4)
Arruolamento3850 partecipanti ricercati

Sponsor e collaboratori

  • AstraZeneca Sponsor

Bracci e interventi

  • 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

Interventi

  • Farmaco 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

  • Farmaco 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

  • Farmaco 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

Esiti misurati

  1. Esito primario

    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

    Orizzonte temporale Approximately 36 months

  2. Esito secondario

    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

    Orizzonte temporale Approximately 36 months

  3. Esito secondario

    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

    Orizzonte temporale Approximately 36 months

  4. Esito secondario

    Time to CV death

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

    Orizzonte temporale Approximately 36 months

  5. Esito secondario

    Time to death from any cause

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

    Orizzonte temporale Approximately 36 months

  6. Esito secondario

    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

    Orizzonte temporale Approximately 24 weeks

Date

Data di inizio12 aprile 2024 (effettiva)
Conclusione primaria16 aprile 2027 (stimata)
Conclusione16 aprile 2027 (stimata)
Prima pubblicazione13 marzo 2024 (effettiva)
Ultimo aggiornamento11 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltasettembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

631 centri stanno reclutando

Argentina

StrutturaCittàStato o regioneStato
Research SiteBuenos AiresIn reclutamento
Research SiteBuenos AiresIn reclutamento
Research SiteBuenos AiresIn reclutamento
Research SiteCABAIn reclutamento
Research SiteCiudad de Buenos AiresIn reclutamento
Research SiteCiudad de Buenos AiresIn reclutamento
Research SiteCorrientesIn reclutamento
Research SiteCórdobaIn reclutamento
Research SiteCórdobaIn reclutamento
Research SiteEsperanzaIn reclutamento
Research SiteGranadero BaigorriaIn reclutamento
Research SiteMar del PlataIn reclutamento
Research SiteRosarioIn reclutamento
Research SiteSan Juan BautistaIn reclutamento
Research SiteSan Miguel de TucumánIn reclutamento
Research SiteSan Miguel de TucumánRitirato
Research SiteSan Miguel de TucumánIn reclutamento
Research SiteSanta FeIn reclutamento

Australia

StrutturaCittàStato o regioneStato
Research SiteBlacktownIn reclutamento
Research SiteCairnsRitirato
Research SiteCanberraIn reclutamento
Research SiteChermsideRitirato
Research SiteClaytonIn reclutamento
Research SiteConcordIn reclutamento
Research SiteFrankstonIn reclutamento
Research SiteGeelongIn reclutamento
Research SiteMurdochIn reclutamento
Research SiteNorth TamworthIn reclutamento
Research SiteWestmeadIn reclutamento

Austria

StrutturaCittàStato o regioneStato
Research SiteBad IschlIn reclutamento
Research SiteBraunau am InnIn reclutamento
Research SiteGrazIn reclutamento
Research SiteLinzIn reclutamento
Research SiteSaint Stefan/StainzIn reclutamento
Research SiteSalzburgIn reclutamento
Research SiteSankt PöltenIn reclutamento
Research SiteViennaIn reclutamento
Research SiteViennaIn reclutamento
Research SiteViennaIn reclutamento
Research SiteVöcklabruckIn reclutamento

Brazil

StrutturaCittàStato o regioneStato
Research SiteAracajuIn reclutamento
Research SiteBlumenauIn reclutamento
Research SiteBrasíliaIn reclutamento
Research SiteCampina Grande do SulIn reclutamento
Research SiteCampinasIn reclutamento
Research SiteCuritibaIn reclutamento
Research SiteGoiâniaIn reclutamento
Research SiteNiteróiRitirato
Research SitePorto AlegreIn reclutamento
Research SiteRio BrancoIn reclutamento

Nella scheda del registro sono indicati altri 802 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 11 settembre 2026

    Data di conclusione anticipata

    Primary completion advanced 56 days

    2027-06-112027-04-16

  2. 11 settembre 2026

    Obiettivo di arruolamento modificato

    Enrollment target revised down from 4800 to 3850

    48003850

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

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