Emulation of the STEP-HFpEF DM Heart Failure Trial in Healthcare Claims Data

Exclusion Criteria

• •Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.
• •Systolic blood pressure \> 160 mmHg at screening.
• •Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g. amyloidosis), hypertrophic obstructive cardiomyopathy, primary pulmonary arterial hypertension, chronic obstructive pulmonary disease, right heart failure due to pulmonary disease, complex congenital heart disease, anemia, or more than moderate heart valve disease).
• •Bariatric surgery prior to screening or planned bariatric surgery within the trial time course.
• •History of type 1 diabetes (history of gestational diabetes is allowed).
• •Treatment with any GLP-1 receptor agonist within 90 days prior to the day of screening.
• •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
• •Recurrent severe hypoglycemic episodes within the last year as judged by the investigator.
• •Treatment with continuous subcutaneous insulin infusion
• •Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
• •Presence of acute pancreatitis within the last 180 days prior to screening.
• •History or presence of chronic pancreatitis.
• •End-stage renal disease or chronic or intermittent hemodialysis or peritoneal dialysis.
• •Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell cancer and any carcinoma in-situ are allowed.
• •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
• •Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.
• •RELAXING ELIGIBILITY OF THE STEP-HFpEF DM TRIAL
• •Prior treatment with any GLP-1-RA
• •History of type 1 diabetes mellitus
• •End-stage renal disease or chronic or intermittent hemodialysis or peritoneal dialysis
• •History of bariatric surgery
• •History of nursing home admission
• •Pregnant female or breast-feeding
• •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy
• •Treatment with continuous subcutaneous insulin infusion
• •Multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
• •Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) for less than 5 years