Efficacy and Safety of Early Initiation of Vericiguat in Heart Failure After Acute Myocardial Infarction

NCT06812546 | Not Yet Recruiting Phase 4 DMC

• 4 other identifiers: VIC-MI82300372; 82270406CSTB2024NSCQ-LZX01442022MSXM028
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure (HF) is a severe cardiovascular disease with extremely high morbidity and mortality rates worldwide, and ischemic cardiomyopathy is an important cause of heart failure. Vericiguat is a soluble guanylate cyclase stimulator which has been verified to improve the cardiovascular outcomes in heart failure patients. The VICTORIA trial excluded patients with acute coronary syndrome in 3 months prior to the study start, so it is still unclear about the efficacy and safety of vericiguat in heart failure after acute myocardial infarction. So we conducted this multi-center, prospective, cohort study to estimate the efficacy and safety of vericiguat in HF patients after acute myocardial infarction.

Conditions

Heart Failure; Acute Myocardial Infarction (AMI); Acute Heart Failure (AHF)

Keywords

Vericiguat; Guideline-Directed Medical Therapy; Heart Failure; Acute myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Serum NT-proBNP Level

  The primary endpoint of the study is NT-proBNP at the baseline \& at the completion of the 24 week intervention

  Up to 24 weeks

Secondary Outcomes (6)

• 6-minute walk distance

  Up to 24 weeks

• NYHA functional class

  Up to 24 weeks

• Worsening heart failure event

  Up to 24 weeks

• Left ventricular ejection fraction

  Up to 24 weeks

• Left ventricular end-diastolic diameter

  Up to 24 weeks

Study Arms (2)

Vericiguat Treatment Group

EXPERIMENTAL

Patients enrolled in the experimental group will receive 26 weeks of oral vericiguat on top of the standard treatment, with vericiguat at a dose of 2.5 mg once a day, doubled every fortnight to a maximum dose of 10 mg once a day at the end of week 6 of the visit, which will be maintained for the duration of the treatment.

Drug: Vericiguat

Standard Treatment Group

NO INTERVENTION

Patients enrolled in the controlled group will receive 26 weeks of standard heart failure and coronary heart disease treatment

Interventions

Vericiguat DRUG

Patients enrolled in the experimental group will receive 26 weeks of oral vericiguat on top of the standard treatment, with vericiguat at a dose of 2.5 mg once a day, doubled every fortnight to a maximum dose of 10 mg once a day at the end of week 6 of the visit, which will be maintained for the duration of the treatment.

Also known as: BAY1021189

Vericiguat Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Undertaking revascularization for criminal coronary artery during hospitalization
• Acute heart failure occurs within 14 days in hospital after STEMI or NSTEMI, meeting all of the following criteria: typical symptoms or signs of heart failure; Treatment with oral or intravenous diuretics is required; LVEF measured by echocardiography is ≤ 45%; Elevated levels of NT proBNP in patients with sinus rhythm ≥ 1000pg/ml and atrial fibrillation/flutter ≥ 1600pg/ml
• eGFR ≥ 15 ml/min/1.73m2
• Informed consent has to be given in written form

You may not qualify if:

• Plan to undergo staged revascularization or if the criminal coronary artery has not been successfully opened
• Severe and uncontrolled lung diseases, such as newly developed pulmonary embolism, primary pulmonary hypertension, acute exacerbation of COPD, etc
• Severe liver and kidney dysfunction, Child Pugh grade C or eGFR \< 15ml/min/1.73m2
• Allergies to ACEI, ARB, ARNI, beta blockers, SGLT2i, MRA, Vericiguat, and other medications
• Symptomatic hypotension or systolic blood pressure less than 90mmHg after discontinuing intravenous medication
• Women in the perinatal period or those planning to conceive
• Patients planning to undergo elective surgical treatment or tumor chemotherapy
• Diagnosed as Takotsubo cardiomyopathy or nonobstructive acute myocardial infarction (MINOCA)
• Previous diagnosis of cardiomyopathy, including but not limited to dilated cardiomyopathy, hypertrophic cardiomyopathy, etc.
• Autoimmune disease or infectious diseases with typical cardiovascular damage, such as syphilis, systemic lupus erythematosus, etc.
• Diagnosed with severe heart valve disease

Sponsors & Collaborators

• Dongying Zhang: lead
• The Second Affiliated Hospital of Chongqing Medical University: collaborator
• The First Affiliated Hospital of Chongqing Medical Universty: collaborator

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400000, China

Location

Related Publications (7)

• Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J, Lam CSP, Ponikowski P, Voors AA, Jia G, McNulty SE, Patel MJ, Roessig L, Koglin J, O'Connor CM; VICTORIA Study Group. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2020 May 14;382(20):1883-1893. doi: 10.1056/NEJMoa1915928. Epub 2020 Mar 28.

  PMID: 32222134 BACKGROUND

• Anker SD, Butler J, Filippatos G, Ferreira JP, Bocchi E, Bohm M, Brunner-La Rocca HP, Choi DJ, Chopra V, Chuquiure-Valenzuela E, Giannetti N, Gomez-Mesa JE, Janssens S, Januzzi JL, Gonzalez-Juanatey JR, Merkely B, Nicholls SJ, Perrone SV, Pina IL, Ponikowski P, Senni M, Sim D, Spinar J, Squire I, Taddei S, Tsutsui H, Verma S, Vinereanu D, Zhang J, Carson P, Lam CSP, Marx N, Zeller C, Sattar N, Jamal W, Schnaidt S, Schnee JM, Brueckmann M, Pocock SJ, Zannad F, Packer M; EMPEROR-Preserved Trial Investigators. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. 2021 Oct 14;385(16):1451-1461. doi: 10.1056/NEJMoa2107038. Epub 2021 Aug 27.

  PMID: 34449189 BACKGROUND

• McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.

  PMID: 31535829 BACKGROUND

• Juilliere Y, Cambou JP, Bataille V, Mulak G, Galinier M, Gibelin P, Benamer H, Bouvaist H, Meneveau N, Tabone X, Simon T, Danchin N; FAST-MI Investigators. Heart failure in acute myocardial infarction: a comparison between patients with or without heart failure criteria from the FAST-MI registry. Rev Esp Cardiol (Engl Ed). 2012 Apr;65(4):326-33. doi: 10.1016/j.recesp.2011.10.027. Epub 2012 Feb 20.

  PMID: 22357361 BACKGROUND

• Bahit MC, Lopes RD, Clare RM, Newby LK, Pieper KS, Van de Werf F, Armstrong PW, Mahaffey KW, Harrington RA, Diaz R, Ohman EM, White HD, James S, Granger CB. Heart failure complicating non-ST-segment elevation acute coronary syndrome: timing, predictors, and clinical outcomes. JACC Heart Fail. 2013 Jun;1(3):223-9. doi: 10.1016/j.jchf.2013.02.007. Epub 2013 Jun 3.

  PMID: 24621874 BACKGROUND

• Steg PG, Dabbous OH, Feldman LJ, Cohen-Solal A, Aumont MC, Lopez-Sendon J, Budaj A, Goldberg RJ, Klein W, Anderson FA Jr; Global Registry of Acute Coronary Events Investigators. Determinants and prognostic impact of heart failure complicating acute coronary syndromes: observations from the Global Registry of Acute Coronary Events (GRACE). Circulation. 2004 Feb 3;109(4):494-9. doi: 10.1161/01.CIR.0000109691.16944.DA. Epub 2004 Jan 26.

  PMID: 14744970 BACKGROUND

• Bahit MC, Kochar A, Granger CB. Post-Myocardial Infarction Heart Failure. JACC Heart Fail. 2018 Mar;6(3):179-186. doi: 10.1016/j.jchf.2017.09.015.

  PMID: 29496021 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

vericiguat

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Dongying Zhang, Professor

  Chongqing Central Hospital of Chongqing University, Chongqing Emergency Medical Center

  STUDY CHAIR

Central Study Contacts

Dongying Zhang, Professor

CONTACT

86-13608398395; zhangdongying@cqu.edu.cn

Junlong Chen, M.D.

CONTACT

86-15111871817; junlongchen2024@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The sonographer who interpreted the report, statistician and the investigating physician who completed the 6-minute walk test could not be aware of the grouping of the patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This study is a multicenter, prospective, randomized controlled trial in which patients will be randomized into either the experimental or control group by uniform stratification from the main centre.

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 6, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

CN (1)