NCT06424288ClinicalTrials.gov

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure

EASi-HF Preserved - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) ≥40%

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.

التواصل مع هذه الدراسة

باختصار

المرحلة 3مطلوب 6,000 مشارك652 موقعاً30 دولة

الفئات

القلب والأوعية الدموية100%

مسجَّلة في سجل واحد

ClinicalTrials.govNCT06424288فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل 4 أسابيع

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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 2024-05-22; recorded start 2024-06-17
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 1218 other studies in this databaseCounted from the lead sponsor named in the record (Boehringer Ingelheim)
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
Blinding16/20
Triple-blind
Control arm13/15
Placebo / sham 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: 652 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: 6,000 participants (target), run at 652 sites, across 30 countries.

How this score is built

Enrolment36/40
6,000 participants (target)
Site count25/25
652 sites
Country count15/15
30 countries
Planned duration9/10
Planned over about 48 months
Sponsor scale10/10
Boehringer Ingelheim has led 1,211 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

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

الحالات

Heart Failure

الأهلية

الأهلية
الجنس	الجميع
الأعمار	18 Years – لا حد أقصى
المتطوعون الأصحّاء	لا

الأهلية كما كُتبت في السجل

Inclusion criteria: 1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information 4. Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2 5. Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2 6. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1: 1. in participants with body mass index (BMI) \<27 kg/m²: ≥300 pg/mL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG) 2. in participants with BMI ≥27 kg/m² to \<35 kg/m²: ≥220 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG) 3. in participants with BMI ≥35 kg/m²: ≥125 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG) 7. At least one of the following: * Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1 * Documented hospitalisation for HF within 6 months prior to Visit 1 * Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1 * in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg/mL * for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg/mL * Urine albumin-to-creatinine ratio (UACR) ≥30 mg/g, analysed at the central laboratory at Visit 1 8. Treated according to best possible standard of care (SOC) (disregarding Sodium-dependent glucose co-transporter 2 inhibitors (SGLT2is) and Mineralocorticoid receptor antagonists (MRAs)) in accordance with applicable HF local/international guidelines and judgment of the investigator Further inclusion criteria apply. Exclusion criteria: 1. Treatment with an mineralocorticoid receptor antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with MRA should not be interrupted with the intention of enrolment into the study 2. Treatment with amiloride, or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator 3. Receiving the following treatments: * a direct renin inhibitor (e.g. aliskiren) at Visit 2 * more than one angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) used simultaneously at Visit 2 * In case of acute decompensated HF: * i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation (Visit 2) * i.v. diuretic with a dose that has been increased/intensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary) * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2 * Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial 4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery/intervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, coronary artery bypass graft surgery/CABG) 5. Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2 6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD) 7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or genetic hypertrophic cardiomyopathy,known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit 2 8. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2 9. Known severe valvular heart disease (obstructive or regurgitant), as per investigator's judgment, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment during the study Further exclusion criteria apply.

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	TRIPLE (3)
التجنيد	مطلوب 6,000 مشارك

الجهة الراعية والمتعاونون

Boehringer Ingelheim الجهة الراعية

الأذرع والتدخلات

vicadrostat/empagliflozinEXPERIMENTAL
placebo/empagliflozinPLACEBO_COMPARATOR

التدخلات

دواء empagliflozin
empagliflozin
دواء placebo
placebo matching vicadrostat
دواء vicadrostat
vicadrostat

مقاييس النتائج

مقياس النتيجة الأولي
Time to first event of Cardiovascular (CV) death, hospitalisation for heart failure (HHF) or urgent heart failure (HF) visit
الإطار الزمني up to 42 months
مقياس النتيجة الثانوي
Key secondary endpoint: Time to first event of CV death or HHF
الإطار الزمني up to 42 months
مقياس النتيجة الثانوي
Key secondary endpoint: Occurrence of HHFs (first and recurrent)
الإطار الزمني up to 42 months
مقياس النتيجة الثانوي
Key secondary endpoint: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) at Week 32
The Kansas City Cardiomyopathy Questionnaire is a patient-reported outcome instrument for use in clinical investigations in heart failure. The Total Symptom Score measures the following aspects of symptom experience in two domain scores: The "Symptom Frequency Domain" assesses frequency of the following experiences: * Lower extremity swelling in the morning * Fatigue limiting patients' ability to do what they want * Dyspnea limiting patients' ability to do what they want * Dyspnea forcing patients to sleep upright/elevated The "Symptom Burden Domain" assesses bothersomeness of the following symptoms: * Fatigue * Dyspnea * Lower extremity swelling All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
الإطار الزمني at baseline, at week 32
مقياس النتيجة الثانوي
Key secondary endpoint: Time to CV death
الإطار الزمني up to 42 months
مقياس النتيجة الثانوي
Key secondary endpoint: Time to all-cause mortality
الإطار الزمني up to 42 months
مقياس النتيجة الثانوي
Time to first HHF
الإطار الزمني up to 42 months
مقياس النتيجة الثانوي
Time to first occurrence of death from kidney failure, chronic dialysis* or renal transplant or onset of sustained reduction of ≥50% eGFR from baseline** or onset of sustained eGFR (CKD-EPI)cr <10 mL/min/1.73 m2 (composite renal endpoint)
\* chronic dialysis is defined as dialysis continuing for at least 30 days \*\* using the Chronic Kidney Disease Epidemiology Collaboration creatinine equation ((CKD-EPI)cr)
الإطار الزمني up to 42 months
مقياس النتيجة الثانوي
Absolute change from baseline in KCCQ Clinical Summary Score (KCCQ-CSS) at Week 32
The KCCQ Clinical Summary Score is a composite of the Total Symptom Score and Physical Limitations Score. The "Physical Limitations Score" measures the following physical limitations: * Dressing * Showering/bathing * Walking one block on level ground * Doing yardwork, housework or carrying groceries * Climbing a flight of stairs without stopping * Hurrying or jogging as if to catch a bus All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
الإطار الزمني at baseline, at week 32
مقياس النتيجة الثانوي
Absolute change from baseline in KCCQ-TSS at Week 52
الإطار الزمني at baseline, at week 52
مقياس النتيجة الثانوي
Absolute change from baseline in KCCQ-OSS at Week 32
The Kansas City Cardiomyopathy Questionnaire - overall summary score (KCCQ-OSS) is a combination of the symptom \[domain\], physical limitations, social limitations, and quality of life domains. All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
الإطار الزمني at baseline, at week 32
مقياس النتيجة الثانوي
Absolute change from baseline in KCCQ-OSS at Week 52
الإطار الزمني at baseline, at week 52
مقياس النتيجة الثانوي
Absolute change from baseline in systolic blood pressure (SBP) [mmHg] at Week 32 in participants with baseline SBP ≥130 mmHg
الإطار الزمني at baseline, at week 32
مقياس النتيجة الثانوي
Absolute chance from baseline in diastolic blood pressure (DBP) [mmHg] at Week 32 in participants with baseline DBP ≥80 mmHg
الإطار الزمني at baseline, at week 32

التواريخ

التواريخ
تاريخ البدء	17 يونيو 2024 (فعلي)
الإتمام الأولي	22 مايو 2028 (تقديري)
الإتمام	22 مايو 2028 (تقديري)
أول نشر	22 مايو 2024 (فعلي)
آخر تحديث	21 أغسطس 2026
النتائج منشورة	غير مذكور في سجل السجل
آخر تأكيد للحالة	أغسطس 2026

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

المواقع

621 موقعاً قيد التجنيد

Argentina

Argentina
المنشأة	المدينة	الحالة
Inst de Inv Clinicas-Bahia Blanca	Bahía Blanca	قيد التجنيد
Swiss Medical Center Barrio Parque	Buenos Aire	قيد التجنيد
Mautalen- Salud e Investigacion	Ciudad Autonoma Buenos Aires	قيد التجنيد
Centro Medico Dra Laura Maffei	Ciudad Autonoma Buenos Aires	قيد التجنيد
Fundacion Favaloro	Ciudad Autonoma Buenos Aires	قيد التجنيد
Glenny Corp. S.A. Bioclinica Argentina	Ciudad Autonoma Buenos Aires	قيد التجنيد
Instituto Cardiovascular de Buenos Aires	Ciudad Autonoma Buenos Aires	قيد التجنيد
Centro de Investigaciones Metabolicas (CINME)-Ciudad Autonoma Buenos Aires-41221	Ciudad Autonoma Buenos Aires	قيد التجنيد
Centro Medico Viamonte	Ciudad Autonoma de Bs As	قيد التجنيد
Hospital Italiano de Buenos Aires	Ciudad Autónoma de Bs As	قيد التجنيد
Instituto Medico Elsa Perez SRL (IMEP)	Ciudadela	قيد التجنيد
Clinica Coronel Suarez	Coronel Suárez	قيد التجنيد
Instituto Médico DAMIC S.R.L.	Córdoba	قيد التجنيد
Sanatorio Allende S.A.	Córdoba	قيد التجنيد
Sanatorio Privado Duarte Quiros De Clinica Colombo SA	Córdoba	قيد التجنيد
Well Medica	Córdoba	قيد التجنيد
Centro Medico Luquez	Córdoba	قيد التجنيد
Centro de Investigaciones Medicas Mar del Plata	Mar del Plata	قيد التجنيد
Hospital Universitario Austral	Pilar	قيد التجنيد
Instituto de Investigaciones Clinicas de Quilmes	Quilmes	قيد التجنيد
DIM Clinica Privada	Ramos Mejía	قيد التجنيد
Instituto CAICI	Rosario	قيد التجنيد
Instituto de Investigaciones Clinicas de Rosario	Rosario	قيد التجنيد
Centro Cardiovascular Salta	Salta	قيد التجنيد
Corporacion Medica de Gral. San Martin S.A.	San Martin	قيد التجنيد
Investigaciones en Patologias Respiratorias	San Miguel de Tucumán	قيد التجنيد
Clinica Mayo	San Miguel de Tucumán	قيد التجنيد
Investigaciones Clinicas Tucuman	San Miguel de Tucumán	قيد التجنيد
Centro Modelo de Cardiologia	San Miguel de Tucumán	قيد التجنيد
Instituto de Investigaciones Clinicas San Nicolas	San Nicolás	قيد التجنيد
Centro de Investigaciones Clinicas del Litoral	Santa Fe	قيد التجنيد
CEMEDIC - Centro de Especialidades Medicas	Villa Luro	قيد التجنيد

Australia

Australia
المنشأة	المدينة	الولاية أو المنطقة	الحالة
Royal Adelaide Hospital	Adelaide	South Australia	قيد التجنيد
Royal Brisbane and Women's Hospital	Brisbane	Queensland	لم يبدأ التجنيد بعد
Prince Charles Hospital	Chermside	Queensland	قيد التجنيد
Concord Repatriation General Hospital	Concord	New South Wales	قيد التجنيد
Total Cardiovascular Care	Frankston	Victoria	قيد التجنيد
Canberra Hospital	Garran	Australian Capital Territory	قيد التجنيد
Gosford Hospital	Gosford	New South Wales	قيد التجنيد
Nepean Hospital	Kingswood	New South Wales	قيد التجنيد
Pendlebury Research	Kotara	New South Wales	قيد التجنيد
Royal Melbourne Hospital	Parkville	Victoria	قيد التجنيد
Mount Hospital	Perth	Western Australia	لم يبدأ التجنيد بعد
John Flynn Private Hospital	Tugun	Queensland	قيد التجنيد
The Queen Elizabeth Hospital	Woodville	South Australia	قيد التجنيد

Belgium

Belgium
المنشأة	المدينة	الحالة
Ziekenhuis Oost-Limburg	Genk	قيد التجنيد
AZ Sint-Lucas	Ghent	قيد التجنيد
Grand Hôpital de Charleroi	Gilly	قيد التجنيد
Jessa Ziekenhuis	Hasselt	قيد التجنيد
AZ Groeninge	Kortrijk	قيد التجنيد

يُدرَج 602 موقع إضافي في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

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

https://xmedica.io/trials/ctgov/NCT06424288