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Can a higher starting dose of vericiguat speed up heart failure treatment?

NCT ID NCT06195930

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether starting the heart failure drug vericiguat at a 5 mg dose (instead of the usual 2.5 mg) is safe and tolerable. 106 adults with chronic heart failure with reduced ejection fraction took the 5 mg tablet daily for about two weeks. The goal was to see if skipping the lower starting step could help patients reach the target 10 mg dose faster without serious side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vericiguat
What this could lead to
If successful, this could allow people with chronic heart failure to skip a lower starting dose and reach the effective target dose faster.
What could go wrong
This is a small, short-term safety study (106 participants, 4 weeks). It does not test long-term benefits or risks, and participants may experience side effects like low blood pressure or dizziness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

106 people

The number who actually took part.

Started

Apr 2024

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has an Left ventricle ejection fraction (LVEF) of \<45% assessed within 12 months before Visit 1 by local any imaging method, and no subsequent LVEF measurement \> 45%. The most recent measurement must be used to determine eligibility. * systolic blood pressure (SBP) ≥ 100 mmHg at screening and Visit 1 (pre-treatment). * No changes in guideline-directed medical therapy for heart failure (GDMT) dosing (including beta blockers, angiotensin-converting enzyme inhibitor/ angiotensin II receptor blocker (ACEI/ARBs), angiotensin receptor-neprilysin inhibitor (ARNI), mineralocorticoid receptor antagonist (MRAs), hydralazine-nitrate combinations, sodium-glucose cotransporter 2 i(SGLT2) inhibitors, ivabradine, or oral diuretics): * Within 4 weeks of screening for participants without a heart failure (HF) event ≤6 months prior to screening * within 2 weeks of screening for participants with a HF event ≤6 months prior to screening * planned during study participation * No expected medical procedures to occur 2 weeks before screening or during study participation. * Participants with ( group 1) OR without (group 2) recent worsening HF event Group 1: History of chronic HF (NYHA class II symptomatic-IV) on GDMT with recent HFevent within 6 months of screening or outpatient IV / SC diuretic use within 3 months before screening. OR Group 2: History of chronic HF (NYHA class II symptomatic-IV) on GDMT without recent HF event within 6 months of screening or outpatient intravenous/ subcutaneous (IV / SC) diuretic use within 3 months before screening. Exclusion Criteria: * History of symptomatic hypotension 4 weeks before screening * Primary valvular heart disease requiring surgical procedure or intervention or has undergone a vascular surgical procedure or intervention within 3months before visit 1 * Hypertrophic cardiomyopathy * Acute myocarditis or Takotsubo cardiomyopathy * Awaiting heart transplantation (United Network for Organ Sharing Class 1A /1B or equivalent) or has or anticipates receiving an implanted ventricular assist device, or has received a heart transplant. * Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia. * Acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction (NSTEMI), or ST elevation myocardial infarction (STEMI), undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 3months before Visit 1, or indication for coronary revascularization at the time of treatment assignment. * Symptomatic carotid stenosis, transient ischemic attack (TIA), or stroke within 3 months before Visit 1. * History of repaired or unrepaired simple congenital heart disease (e.g., atrial or ventricular septal defects, or patent ductus arteriosus) with ongoing hemodynamically significant residual lesions, or any history of complex congenital heart disease (e.g. tetralogy of Fallot, transposition of the great arteries, single ventricle disease) regardless of repair status. * Active endocarditis or constrictive pericarditis. * Hemodynamic instability or hypovolemia within 4 weeks of screening and during the screening period. * Currently hospitalized. * estimated glomerular filtration rate (eGFR) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation of \<15 mL/min/1.73 m2 within 30 days before Visit 1 or on chronic dialysis. For participants with multiple eGFR results during screening, the most recent value will be used to determine eligibility. * Severe hepatic insufficiency defined as albumin to bilirubin ratio (ALBI) Grade 3 or hepatic encephalopathy, or has hepatic laboratory abnormalities (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 ×upper limit of normal (ULN) or total bilirubin ≥2 × ULN). Exceptions for Gilbert's syndrome will be considered. Albumin, ALT, AST, and total bilirubin results within 30 days before Visit 1 may be used for assessment of laboratory abnormalities or the calculation of the ALBI score. For participants with multiple albumin and/or total bilirubin results during screening, the most recent value for each test will be used to calculate ALBI score. * Malignancy or other noncardiac condition limiting life expectancy to \<3years. * Requires continuous home oxygen for severe pulmonary disease. * Interstitial lung disease. * Known allergy or hypersensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator. * Amyloidosis or sarcoidosis. * Concurrent or anticipated concomitant use of phosphodiesterase type 5 (PDE5) inhibitors such as vardenafil, tadalafil, and sildenafil during the study. * Concurrent use of an sGC stimulator such as riociguat or vericiguat. * Prior (within 2 weeks prior to screening) or anticipated concomitant administration of IV / SC diuretics or inotropes.

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Conditions

The condition(s) this trial relates to.

systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic heart failure with reduced ejection fraction

Contacts and locations

Locations

  • ASST Papa Giovanni XXIII

    Bergamo, Lombardy, 24127, Italy

  • ASST Spedali Civili di Brescia

    Brescia, Lombardy, 25123, Italy

  • Advanced Cardiovascular, LLC - Alexander City

    Alexander City, Alabama, 35010, United States

  • Ascension Saint Agnes Heart Care

    Baltimore, Maryland, 21229, United States

  • CEDIC Centro de Investigación Clínica | Buenos Aires, Argentina

    CABA, Ciudad Auton. de Buenos Aires, C1018DES, Argentina

  • Capio Citykliniken - Hjartmottagning

    Lund, 222 21, Sweden

  • Centro de Investigacion y Prevencion Cardiovascular | Sede Recoleta

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1119ACN, Argentina

  • Centro de Investigaciones Clinicas del Litoral | Santa Fe, Argentina

    Santa Fe, S3000FWO, Argentina

  • Centrum Medyczne Zdrowa

    Krakow, 31-216, Poland

  • Chear Center LLC

    New York, New York, 10455, United States

  • Clinical Best Solutions Sp. Z O.O. Sp.K.

    Lublin, 20-011, Poland

  • Clinical Best Solutions Sp. Z O.O. Sp.K.

    Warsaw, 00-710, Poland

  • Complex Rendelo Med Zrt.

    Székesfehérvár, 8000, Hungary

  • Consultorios Integrados Rosario | Instituto Medico de la Fundacion de Estudios Clinicos

    Rosario, Santa Fe Province, S2000DEJ, Argentina

  • Coromed Smo Kft

    Pécs, 7623, Hungary

  • Eszak-Pesti Centrumkorhaz-Honvedkorhaz

    Budapest, 1134, Hungary

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Lombardy, 27100, Italy

  • Hospital Clinico Universitario de Santiago de Compostela | Cardiology Department

    Santiago de Compostela, A Coruña, 15706, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Ramon y Cajal | Cardiology - Research Unit

    Madrid, 28034, Spain

  • Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology Department

    Barcelona, 08907, Spain

  • Hospital del Mar | Cardiology Department

    Barcelona, 08003, Spain

  • Hospital la Paz

    Madrid, 28046, Spain

  • IRCCS Centro Cardiologico Monzino

    Milan, Lombardy, 20138, Italy

  • IRMED Osrodek Badan Klinicznych

    Piotrkow Trybunalski, 97-300, Poland

  • Instituto de Cardiologia de Corrientes Juana F. Cabral | Corrientes, Argentina

    Corrientes, 3400, Argentina

  • Karolinska Universitetssjukhuset

    Stockholm, 17176, Sweden

  • Malopolskie Centrum Sercowo-Naczyniowe PAKS

    Chrzanów, 32-500, Poland

  • NZOZ "Twoja Przychodnia" Sp. z o.o.

    Lublin, 20-857, Poland

  • Reid Physician Associates | Cardiology Department

    Richmond, Indiana, 47374, United States

  • Semmelweis Egyetem Belgyógyaszati és Haematológiai Klinika, Kardiológia

    Budapest, 1088, Hungary

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400, Hungary

  • St. Louis Heart & Vascular, PC

    St Louis, Missouri, 63136, United States

  • Tolna Varmegyei Balassa Janos Korhaz

    Szekszárd, 7100, Hungary

  • Vita Longa Sp. z o.o.

    Katowice, 40-748, Poland

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