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The effect of sertraline on anxiety-depressive symptoms, endothelial dysfunction and biomarkers in heart failure patients with preserved ejection fraction
EU CTIS ID: 2024-515061-33-00
What this study is testing
Assessment of time to hospitalization for cardiovascular reasons or death from any cause
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- a. 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.
You likely can't join if
- a. 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.