The effect of sertraline on anxiety-depressive symptoms, endothelial dysfunction and biomarkers in heart failure patients with preserved ejection fraction

Lab values

• Current participation in another clinical trial; b. Presence of suicidal behavior or thoughts in the period from 3 months preceding screening to the randomization visit – maximum score for question no. 9 in the PHQ-9 test; c. Blood Hb concentration <11.0 g/dl d. Abnormal renal function: blood creatinine concentration >2.0 mg/dl or eGFR <30 ml/min; e. Blood sodium concentration <130 mmol/l; f. Use of warfarin or acenocoumarol; g. Psychosis or bipolar disorder ever in the patient's medical records; h. Epilepsy or seizures ever in the patient's medical records; i. Use of antidepressants in the 4 weeks preceding screening; j. Diagnosed malignancy in the last 2 years before screening; k. Inability to attend all visits scheduled in the study; l. Angina symptoms ≥3 on the CCS scale; m. Revascularization or venous thromboembolism within 3 months prior to screening; n. Use of another study drug within 3 months prior to screening; o. Hemodynamically significant valvular disease or hypertrophic cardiomyopathy; p. Active infection as assessed by the investigator; q. Myocarditis or pericarditis within 1 year prior to screening; r. Significant atrial or ventricular septal defect; s. Cardiac amyloidosis in the patient's medical records; t. Severe ventricular arrhythmias; u. Uncontrolled blood pressure: SBP >170 or or DBP >100 mmHg at the screening or randomization visit; v. Resting heart rate (HR) >110/min or <50/min; w. Blood enzymatic activity ALAT or AST ≥3 times the upper limit of the reference range (UVR); x. Life expectancy of the patient <2 years; y. Organ transplant recipient; z. Severe dysfunction of the musculoskeletal system that prevents the patient from moving independently; aa. History of intolerance to sertraline or other SSRI drugs (treatment duration less than 8 weeks); bb. active gastric and/or duodenal ulcer; cc. history of gastrointestinal bleeding.

• Expression of willingness to participate in the study and after obtaining information about the study, signing an informed consent form to participate in the clinical trial; b. Patient age at enrollment ≥60 years and <85 years; c. Score ≥10 in the Patient Health Questionnaire PHQ-9 and/or score ≥10 in the Generalized Anxiety Disorder GAD-7; d. Documented diagnosis of HFpEF or new diagnosis of HFpEF based on obtaining ≥5 points according to the HFA-PEFF criteria by the investigator during the screening phase.