Niewydolność serca: badanie fazy III leku maritide

Kryteria wyłączenia kto nie może wziąć udziału (22)

1. History of any of the following within 60 days prior to or during screening: Type I (spontaneous) MI, valvular replacement or repair, coronary revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke.
2. HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active or chronic myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease.
3. Hospitalized with acute decompensated HF at the time of or during the screening period.
4. Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes.
5. For participants with a prior diagnosis of T2DM (including those diagnosed during screening):
6. HbA1c > 10.0% (86 mmol/mol) at screening
7. Uncontrolled diabetes requiring immediate therapy
8. History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization
9. One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness
10. History or presence of either proliferative diabetic retinopathy, or diabetic maculopathy, or severe non-proliferative diabetic retinopathy; or currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
11. SBP ≥ 180 mmHg during the screening period, or on three or more blood pressure-lowering drugs with a SBP > 160 mmHg during the screening period (including day 1 prior to randomization).
12. History of chronic pancreatitis or acute pancreatitis in the 180 days before screening or during the screening period.
13. Any personal lifetime history of, or family history(first-degree relative[s]) of medullary thyroid carcinoma or MEN-2.
14. eGFR < 20 mL/min/1.73 m^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening.
15. Calcitonin ≥ 50 ng/L (pg/mL) at screening.
16. Acute or chronic hepatitis.
17. Any of the following psychiatric history:
18. History of unstable major depressive disorder or other severe psychiatric disorder within 2 years prior to screening or during the screening period
19. Lifetime history of suicide attempt
20. History of non-suicidal self-injury within 5 years prior to screening or during the screening period.
21. History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the trial.
22. Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days prior to or during the screening period or planned use during the conduct of the trial.