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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 3مطلوب 11,300 مشارك957 موقعاً35 دولة

الفئات

القلب والأوعية الدموية100%

مسجَّلة في سجل واحد

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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 2024-11-06; 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.

ملخص

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.

الحالات

  • Heart Failure

الأهلية

الجنسالجميع
الأعمار40 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيPREVENTION
التعميةQUADRUPLE (4)
التجنيدمطلوب 11,300 مشارك

الجهة الراعية والمتعاونون

  • AstraZeneca الجهة الراعية

الأذرع والتدخلات

  • 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

التدخلات

  • دواء Baxdrostat and dapagliflozin

    baxdrostat tablet and dapagliflozin tablet

  • أخرى Placebo and dapagliflozin

    placebo tablet and dapagliflozin tablet

مقاييس النتائج

  1. مقياس النتيجة الأولي

    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

    الإطار الزمني Event driven; Up to 38 months

  2. مقياس النتيجة الثانوي

    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

    الإطار الزمني Event driven; Up to 38 months

  3. مقياس النتيجة الثانوي

    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

    الإطار الزمني Event driven; Up to 38 months

  4. مقياس النتيجة الثانوي

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

    Time to CV death

    الإطار الزمني Event driven; Up to 38 months

  5. مقياس النتيجة الثانوي

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

    Time to all-cause death

    الإطار الزمني Event driven; Up to 38 months

  6. مقياس النتيجة الثانوي

    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

    الإطار الزمني Event driven; Up to 38 months

التواريخ

تاريخ البدء14 مارس 2025 (فعلي)
الإتمام الأولي17 ديسمبر 2029 (تقديري)
الإتمام17 ديسمبر 2029 (تقديري)
أول نشر6 نوفمبر 2024 (فعلي)
آخر تحديث15 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةسبتمبر 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

830 موقعاً قيد التجنيد

Argentina

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Australia

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Brazil

المنشأةالمدينةالولاية أو المنطقةالحالة
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تُدرَج 907 مواقع إضافية في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 15 سبتمبر 2026

    أُضيف موقع

    4 sites added (957 total)

    953957

  2. 31 يوليو 2026

    أُضيف موقع

    11 sites added (953 total)

    942953

السجل: ClinicalTrials.gov · NCT########

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