None listed
Conditions
Interventions
Tablets, 2.5mg, 5mg y 10mg, QD, 21 months, oral, MK-1242 o placebo
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Eligibility
Sex/Gender
All
Inclusion 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
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
Countries
Argentina, Austria, Belgium, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Ireland, Japan, New Zealand, Russian Federation, Sweden, Switzerland, United Kindgdom
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed