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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.

التواصل مع هذه الدراسة

باختصار

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…

المرحلة 3مطلوب 3,850 مشاركاً852 موقعاً39 دولة

الفئات

القلب والأوعية الدموية68%الكلى والمسالك البولية32%

مسجَّلة في سجل واحد

ClinicalTrials.govNCT06307652فتح هذا السجل في ClinicalTrials.govتمت المزامنة الأسبوع الماضي

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هل أنت مهتم بهذه الدراسة؟

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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.

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

ملخص

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.

الحالات

Heart Failure and Impaired Kidney Function

الأهلية

الأهلية
الجنس	الجميع
الأعمار	18 Years – 130 Years
المتطوعون الأصحّاء	لا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

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

تصميم الدراسة

تصميم الدراسة
نوع الدراسة	تدخّلية
المرحلة	المرحلة 3
التخصيص	معشّاة
نموذج التدخّل	PARALLEL
الغرض الأساسي	TREATMENT
التعمية	QUADRUPLE (4)
التجنيد	مطلوب 3,850 مشاركاً

الجهة الراعية والمتعاونون

AstraZeneca الجهة الراعية

الأذرع والتدخلات

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

التدخلات

دواء 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
دواء 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
دواء 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

مقاييس النتائج

مقياس النتيجة الأولي
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
الإطار الزمني Approximately 36 months
مقياس النتيجة الثانوي
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
الإطار الزمني Approximately 36 months
مقياس النتيجة الثانوي
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
الإطار الزمني Approximately 36 months
مقياس النتيجة الثانوي
Time to CV death
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death
الإطار الزمني Approximately 36 months
مقياس النتيجة الثانوي
Time to death from any cause
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause
الإطار الزمني Approximately 36 months
مقياس النتيجة الثانوي
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
الإطار الزمني Approximately 24 weeks

التواريخ

التواريخ
تاريخ البدء	12 أبريل 2024 (فعلي)
الإتمام الأولي	16 أبريل 2027 (تقديري)
الإتمام	16 أبريل 2027 (تقديري)
أول نشر	13 مارس 2024 (فعلي)
آخر تحديث	11 سبتمبر 2026
النتائج منشورة	غير مذكور في سجل السجل
آخر تأكيد للحالة	سبتمبر 2026

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

المواقع

631 موقعاً قيد التجنيد

Argentina

Argentina
المنشأة	المدينة	الحالة
Research Site	Buenos Aires	قيد التجنيد
Research Site	Buenos Aires	قيد التجنيد
Research Site	Buenos Aires	قيد التجنيد
Research Site	CABA	قيد التجنيد
Research Site	Ciudad de Buenos Aires	قيد التجنيد
Research Site	Ciudad de Buenos Aires	قيد التجنيد
Research Site	Corrientes	قيد التجنيد
Research Site	Córdoba	قيد التجنيد
Research Site	Córdoba	قيد التجنيد
Research Site	Esperanza	قيد التجنيد
Research Site	Granadero Baigorria	قيد التجنيد
Research Site	Mar del Plata	قيد التجنيد
Research Site	Rosario	قيد التجنيد
Research Site	San Juan Bautista	قيد التجنيد
Research Site	San Miguel de Tucumán	قيد التجنيد
Research Site	San Miguel de Tucumán	مسحوب
Research Site	San Miguel de Tucumán	قيد التجنيد
Research Site	Santa Fe	قيد التجنيد

Australia

Australia
المنشأة	المدينة	الحالة
Research Site	Blacktown	قيد التجنيد
Research Site	Cairns	مسحوب
Research Site	Canberra	قيد التجنيد
Research Site	Chermside	مسحوب
Research Site	Clayton	قيد التجنيد
Research Site	Concord	قيد التجنيد
Research Site	Frankston	قيد التجنيد
Research Site	Geelong	قيد التجنيد
Research Site	Murdoch	قيد التجنيد
Research Site	North Tamworth	قيد التجنيد
Research Site	Westmead	قيد التجنيد

Austria

Austria
المنشأة	المدينة	الحالة
Research Site	Bad Ischl	قيد التجنيد
Research Site	Braunau am Inn	قيد التجنيد
Research Site	Graz	قيد التجنيد
Research Site	Linz	قيد التجنيد
Research Site	Saint Stefan/Stainz	قيد التجنيد
Research Site	Salzburg	قيد التجنيد
Research Site	Sankt Pölten	قيد التجنيد
Research Site	Vienna	قيد التجنيد
Research Site	Vienna	قيد التجنيد
Research Site	Vienna	قيد التجنيد
Research Site	Vöcklabruck	قيد التجنيد

Brazil

Brazil
المنشأة	المدينة	الحالة
Research Site	Aracaju	قيد التجنيد
Research Site	Blumenau	قيد التجنيد
Research Site	Brasília	قيد التجنيد
Research Site	Campina Grande do Sul	قيد التجنيد
Research Site	Campinas	قيد التجنيد
Research Site	Curitiba	قيد التجنيد
Research Site	Goiânia	قيد التجنيد
Research Site	Niterói	مسحوب
Research Site	Porto Alegre	قيد التجنيد
Research Site	Rio Branco	قيد التجنيد

يُدرَج 802 موقع إضافي في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

11 سبتمبر 2026
قُدِّم تاريخ الإتمام
Primary completion advanced 56 days
2027-06-112027-04-16
11 سبتمبر 2026
تغيّر هدف التجنيد
Enrollment target revised down from 4800 to 3850
48003850

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

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