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%

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

Phase 36 000 participants recherchés652 sites30 pays

Catégories

Cardiovasculaire100%

Enregistré dans 1 registre

ClinicalTrials.govNCT06424288Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 4 semaines

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

Cette étude vous intéresse ?

Se connecter ou créez un compte pour manifester votre intérêt et suivre cette étude.

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.

Résumé

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.

Affections

Heart Failure

Éligibilité

Éligibilité
Sexe	Tous
Âges	18 Years – Aucun maximum
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

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.

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Phase 3
Répartition	Randomisée
Modèle d'intervention	PARALLEL
Objectif principal	TREATMENT
Insu	TRIPLE (3)
Recrutement	6 000 participants recherchés

Promoteur et collaborateurs

Boehringer Ingelheim Promoteur

Groupes et interventions

vicadrostat/empagliflozinEXPERIMENTAL
placebo/empagliflozinPLACEBO_COMPARATOR

Interventions

Médicament empagliflozin
empagliflozin
Médicament placebo
placebo matching vicadrostat
Médicament vicadrostat
vicadrostat

Critères de jugement

Critère de jugement principal
Time to first event of Cardiovascular (CV) death, hospitalisation for heart failure (HHF) or urgent heart failure (HF) visit
Délai up to 42 months
Critère de jugement secondaire
Key secondary endpoint: Time to first event of CV death or HHF
Délai up to 42 months
Critère de jugement secondaire
Key secondary endpoint: Occurrence of HHFs (first and recurrent)
Délai up to 42 months
Critère de jugement secondaire
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.
Délai at baseline, at week 32
Critère de jugement secondaire
Key secondary endpoint: Time to CV death
Délai up to 42 months
Critère de jugement secondaire
Key secondary endpoint: Time to all-cause mortality
Délai up to 42 months
Critère de jugement secondaire
Time to first HHF
Délai up to 42 months
Critère de jugement secondaire
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)
Délai up to 42 months
Critère de jugement secondaire
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.
Délai at baseline, at week 32
Critère de jugement secondaire
Absolute change from baseline in KCCQ-TSS at Week 52
Délai at baseline, at week 52
Critère de jugement secondaire
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.
Délai at baseline, at week 32
Critère de jugement secondaire
Absolute change from baseline in KCCQ-OSS at Week 52
Délai at baseline, at week 52
Critère de jugement secondaire
Absolute change from baseline in systolic blood pressure (SBP) [mmHg] at Week 32 in participants with baseline SBP ≥130 mmHg
Délai at baseline, at week 32
Critère de jugement secondaire
Absolute chance from baseline in diastolic blood pressure (DBP) [mmHg] at Week 32 in participants with baseline DBP ≥80 mmHg
Délai at baseline, at week 32

Dates

Dates
Date de début	17 juin 2024 (réelle)
Achèvement principal	22 mai 2028 (estimée)
Achèvement	22 mai 2028 (estimée)
Première publication	22 mai 2024 (réelle)
Dernière mise à jour	21 août 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	août 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

621 sites sont en recrutement

Argentina

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

Australia

Australia
Établissement	Ville	État ou région	Statut
Royal Adelaide Hospital	Adelaide	South Australia	En recrutement
Royal Brisbane and Women's Hospital	Brisbane	Queensland	Pas encore en recrutement
Prince Charles Hospital	Chermside	Queensland	En recrutement
Concord Repatriation General Hospital	Concord	New South Wales	En recrutement
Total Cardiovascular Care	Frankston	Victoria	En recrutement
Canberra Hospital	Garran	Australian Capital Territory	En recrutement
Gosford Hospital	Gosford	New South Wales	En recrutement
Nepean Hospital	Kingswood	New South Wales	En recrutement
Pendlebury Research	Kotara	New South Wales	En recrutement
Royal Melbourne Hospital	Parkville	Victoria	En recrutement
Mount Hospital	Perth	Western Australia	Pas encore en recrutement
John Flynn Private Hospital	Tugun	Queensland	En recrutement
The Queen Elizabeth Hospital	Woodville	South Australia	En recrutement

Belgium

Belgium
Établissement	Ville	Statut
Ziekenhuis Oost-Limburg	Genk	En recrutement
AZ Sint-Lucas	Ghent	En recrutement
Grand Hôpital de Charleroi	Gilly	En recrutement
Jessa Ziekenhuis	Hasselt	En recrutement
AZ Groeninge	Kortrijk	En recrutement

602 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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