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NCT06677060ClinicalTrials.gov

Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin

A Phase III, Randomised, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least…

שלב 3דרושים 11,300 משתתפים957 אתרים35 מדינות

קטגוריות

לב וכלי דם100%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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 2024-11-06; recorded start 2025-03-14
  • 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 arm0/15

    No comparator arm stated in the record

  • 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: 942 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

ScaleMEGA

A very large study, international in scope: 11,300 participants (target), run at 957 sites, across 35 countries.

How this score is built
  • Enrolment38/40

    11,300 participants (target)

  • Site count25/25

    942 sites

  • Country count15/15

    35 countries

  • Planned duration10/10

    Planned over about 58 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.

תקציר

Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF. The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1. Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation. Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD. In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.

מצבים רפואיים

  • Heart Failure

זכאות

מיןהכול
גילאים40 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

Inclusion Criteria: * Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent. * Diagnosed with T2DM and requiring treatment * Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease) * History of HTN and an SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the Randomisation Visit. * At least one additional risk factor for HF: * Age ≥ 70 years * UACR \> 20 mg/g * eGFR \< 60 mL/min/1.73 m2 * History of polyvascular disease (at least two of: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease) * History of atrial fibrillation or atrial flutter * NT-proBNP \> 125 ng/L Exclusion Criteria: * Previously confirmed diagnosis and treatment of heart failure * An eGFR \< 30 mL/min/1.73 m2 at screening * Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening * Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c \> 10.5% (\> 91 mmol/mol) at screening * Serum sodium \< 135 mmol/L at screening, determined as per central laboratory assessment * Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation * Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation * Percutaneous coronary intervention within 1 month prior to randomisation * Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history * Documented history of adrenal insufficiency * Any dialysis (including for acute kidney injury) within 3 months prior to screening * Any acute kidney injury within 3 months prior to screening * Prohibited concomitant medications

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתPREVENTION
הסתרהQUADRUPLE (4)
גיוסדרושים 11,300 משתתפים

נותן חסות ושותפים

  • AstraZeneca נותן חסות

זרועות והתערבויות

  • Baxdrostat/DapagliflozinEXPERIMENTAL

    Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.

  • Placebo/DapagliflozinEXPERIMENTAL

    Patients will receive a dose of dapagliflozin in combination with matching placebo

התערבויות

  • תרופה Baxdrostat and dapagliflozin

    baxdrostat tablet and dapagliflozin tablet

  • אחר Placebo and dapagliflozin

    placebo tablet and dapagliflozin tablet

מדדי תוצאה

  1. מדד תוצאה ראשוני

    To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of an HF event or CV death

    Time to first occurrence of any of the components of the composite of: * Hospitalisation for HF * HF without hospitalisation * CV death

    מסגרת זמן Event driven; Up to 38 months

  2. מדד תוצאה משני

    To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of hospitalisation for HF or CV death

    Time to first occurrence of any of the components of the composite of: * Hospitalisation for HF * CV death

    מסגרת זמן Event driven; Up to 38 months

  3. מדד תוצאה משני

    To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of HF events

    Time to first occurrence of any of the components of the composite of: * Hospitalisation for HF * HF without hospitalisation

    מסגרת זמן Event driven; Up to 38 months

  4. מדד תוצאה משני

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

    Time to CV death

    מסגרת זמן Event driven; Up to 38 months

  5. מדד תוצאה משני

    To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of all-cause mortality

    Time to all-cause death

    מסגרת זמן Event driven; Up to 38 months

  6. מדד תוצאה משני

    To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of 4-point MACE (CV death, MI, stroke, and hospitalisation for HF)

    Time to first occurrence of any of the components of the composite of: * CV death * MI * Stroke * Hospitalisation for HF

    מסגרת זמן Event driven; Up to 38 months

תאריכים

תאריך התחלה14 במרץ 2025 (בפועל)
סיום ראשוני17 בדצמבר 2029 (משוער)
סיום17 בדצמבר 2029 (משוער)
פורסם לראשונה6 בנובמבר 2024 (בפועל)
עודכן לאחרונה15 בספטמבר 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהספטמבר 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

830 אתרים מגייסים

Argentina

מתקןעירמדינה או אזורמצב
Research SiteBuenos Airesמגייס
Research SiteBuenos Airesמגייס
Research SiteCABAמגייס
Research SiteCABAמגייס
Research SiteCabaמגייס
Research SiteCiudad de Buenos Airesמגייס
Research SiteCórdobaמגייס
Research SiteCórdobaטרם מגייס
Research SiteLa Plataטרם מגייס
Research SiteMar del Plataטרם מגייס
Research SiteMar del Plataמגייס
Research SiteRosarioמגייס
Research SiteRosarioמגייס
Research SiteSan Nicolásמגייס
Research SiteSan Nicolás de los Arroyosטרם מגייס
Research SiteSan Vicenteמגייס
Research SiteSanta Feמגייס

Australia

מתקןעירמדינה או אזורמצב
Research SiteAdelaideמגייס
Research SiteCastle Hillמגייס
Research SiteCoffs Harbourמגייס
Research SiteElizabeth Valeמגייס
Research SiteFremantleמגייס
Research SiteGeelongמגייס
Research SiteKingswoodהופסק
Research SiteLeabrookמגייס
Research SiteMaroubraמגייס
Research SiteMerewetherמגייס
Research SiteMiltonמגייס
Research SiteMulgraveבוטל
Research SiteOsborne Parkמגייס
Research SiteRockhamptonמגייס
Research SiteWollongongמגייס

Brazil

מתקןעירמדינה או אזורמצב
Research SiteBelémמגייס
Research SiteBlumenauמגייס
Research SiteBragança Paulistaמגייס
Research SiteBrasíliaמגייס
Research SiteCampina Grande do Sulמגייס
Research SiteCampinasמגייס
Research SiteCampinasמגייס
Research SiteCuritibaמגייס
Research SiteCuritibaמגייס
Research SiteJuiz de Foraבוטל
Research SiteNatalמגייס
Research SitePorto Alegreמגייס
Research SitePorto Alegreמגייס
Research SitePorto Alegreמגייס
Research SitePorto Alegreמגייס
Research SiteRio de Janeiroמגייס
Research SiteSão José do Rio Pretoמגייס
Research SiteSão José dos Camposמגייס

907 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 15 בספטמבר 2026

    אתר נוסף

    4 sites added (957 total)

    953957

  2. 31 ביולי 2026

    אתר נוסף

    11 sites added (953 total)

    942953

מרשם: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06677060