A RANDOMIZED PARALLEL-GROUP, PLACEBO-CONTROLLED, DOUBLE-BLIND, EVENT-DRIVEN, MULTI- CENTER PIVOTAL PHASE III CLINICAL OUTCOME TRIAL OF EFFICACY AND SAFETY OF THE ORAL SGC STIMULATOR VERICIGUAT IN SUBJECTS WITH HEART FAILURE WITH REDUCED EJECTION FRACTION (HFREF) - VERICIGUAT GLOBAL STUDY IN SUBJECTS WITH HEART FAILURE WITH REDUCED EJECTION FRACTION (VICTORIA)

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-031-17
• Date of registration: 26/12/2017
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
• Public title: A RANDOMIZED PARALLEL-GROUP, PLACEBO-CONTROLLED, DOUBLE-BLIND, EVENT-DRIVEN, MULTI- CENTER PIVOTAL PHASE III CLINICAL OUTCOME TRIAL OF EFFICACY AND SAFETY OF THE ORAL SGC STIMULATOR VERICIGUAT IN SUBJECTS WITH HEART FAILURE WITH REDUCED EJECTION FRACTION (HFREF) - VERICIGUAT GLOBAL STUDY IN SUBJECTS WITH HEART FAILURE WITH REDUCED EJECTION FRACTION (VICTORIA)
• Scientific title: A RANDOMIZED PARALLEL-GROUP, PLACEBO-CONTROLLED, DOUBLE-BLIND, EVENT-DRIVEN, MULTI- CENTER PIVOTAL PHASE III CLINICAL OUTCOME TRIAL OF EFFICACY AND SAFETY OF THE ORAL SGC STIMULATOR VERICIGUAT IN SUBJECTS WITH HEART FAILURE WITH REDUCED EJECTION FRACTION (HFREF) - VERICIGUAT GLOBAL STUDY IN SUBJECTS WITH HEART FAILURE WITH REDUCED EJECTION FRACTION (VICTORIA)
• Date of first enrolment: 01/03/2018
• Target sample size: 80
• Recruitment status: Recruiting
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=031-17
• Study type: Interventional
• Study design: This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, eventdriven trial of MK-1242 (vericiguat) in subjects with heart failure with reduced ejection fraction (HFrEF) to be conducted in conformance with Good Clinical Practice (GCP).; Approximately 4872 subjects will be randomized in this trial to evaluate the efficacy and; safety of MK-1242 (vericiguat) compared with placebo, on a background of standard of care.; After a screening phase of up to 30 days, eligible subjects will be treated until the required number of cardiovascular (CV) death events is observed (estimated median follow -up duration of approximately 18 months). All subjects will be followed until study completion to assess for the occurrence of endpoint events. Please refer to the protocol for more information.
• Phase: III

Countries of recruitment

Argentina, Austria, Belgium, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Ireland, Japan, New Zealand, Russian Federation, Sweden, Switzerland, United Kindgdom

Contacts

• Name: Nelva Coral Garcia
• Affiliation: MERCK SHARP & DOHME PERU S.R.L

• Name: Alexandra Denegri-Cornejo Lopez
• Affiliation: MERCK SHARP & DOHME PERU S.R.L

Key inclusion & exclusion criteria

Inclusion criteria:
1. Provide written informed consent for the trial. 2. Be male or female, aged 18 years or older on the day of signing informed consent. 3. Have a history of chronic HF (NYHA class II-IV) on standard therapy before qualifying
HF decompensation.4. Have a previous HF hospitalization within 6 months prior to randomization or IV diuretic
treatment for HF (without hospitalization) within 3 months prior to randomization. 5. Have brain natriuretic peptide (BNP) or NT-proBNP levels within 30 days prior to randomization as per protocol. 6. Have a left ventricular ejection fraction (LVEF) of <45% assessed within 12 months prior to randomization by any method (most recent measurement must be used to determine eligibility).7 The subject is a male. The subject is a female who is not of reproductive potential. The subject is a female who is of reproductive potential and agrees to avoid
becoming pregnant

Exclusion criteria:
1. Is clinically unstable at the time of randomization as defined by: Administration of any intravenous treatment within 24 hours prior to randomization, and/or Systolic blood pressure (SBP) <100 mmHg or symptomatic hypotension.
2. Has concurrent or anticipated use of long-acting nitrates or NO donors including
isosorbide dinitrate, isosorbide 5-mononitrate, and others. 3. Has concurrent use or anticipated use of phosphodiesterase type 5 (PDE5) inhibitors such as vardenafil, tadalafil, and sildenafil.
4. Has concurrent use or anticipated use of a sGC stimulator such as riociguat. 5. Has known allergy or sensitivity to any sGC stimulator. 6. Is awaiting heart transplantation (United Network for Organ Sharing Class 1A / 1B or
equivalent), receiving continuous IV infusion of an inotrope, or has/anticipates
receiving an implanted ventricular assist device. 7. Has primary valvular heart disease requiring surgery or intervention, or is within 3 months after valvular surgery or intervention. 8. Has hypertrophic obstructive cardiomyopathy. 9. Has acute myocarditis, amyloidosis, sarcoidosis, Takotsubo cardiomyopathy.
10. Has post-heart transplant cardiomyopathy. And Others. For more information please refer to the protocol


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

-I50

I50

Intervention(s)

Tablets, 2.5mg, 5mg y 10mg, QD, 21 months, oral, MK-1242 o placebo

Source(s) of Monetary Support

Merck Sharp & Dohme Corp. (una subsidiaria de Merck & Co. Inc.)

Ethics review

Status: Approved
Approval date: 17/08/2017
Contact:

[e-mail]

Hospital Cayetano Heredia

97254626

[e-mail]

Status: Approved
Approval date: 24/08/2017
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 14/09/2017
Contact:

[e-mail]

Hospital Nacional Alberto Sabogal Sologuren

4297744 anexo 5388

[e-mail]

Status: Approved
Approval date: 14/12/2017
Contact:

[e-mail]

Hospital Nacional Alberto Sabogal Sologuren

4297744 anexo 5388

[e-mail]

Results

• Results available: Yes
• Date Completed: 26/08/2019