The effect of sertraline on anxiety-depressive symptoms, endothelial dysfunction and biomarkers in heart failure patients with preserved ejection fraction
Key facts
- Where
- Bydgoszcz, Gdansk, Gdańsk, Gdynia, Słupsk és Warsaw, LengyelországSee the 8 sites
- Phase
- 3. fázis
Where in Lengyelország
- Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W BydgoszczyBydgoszcz, LengyelországNo longer taking part
- Copernicus Podmiot Leczniczy Sp. z o.oGdansk, LengyelországNo longer taking part
- Uniwersyteckie Centrum Kliniczne w GdańskuGdansk, LengyelországNo longer taking part
- Kardio LifeGdańsk, LengyelországNo longer taking part
- Niepubliczny Zakład Opieki ZdrowotnejGdańsk, LengyelországNo longer taking part
- Uniwersyteckie Centrum Medycyny Morskiej i TropikalnejGdynia, LengyelországNo longer taking part
- Szpital Specjalistyczny im. Janusza Korczaka w SłupskuSłupsk, LengyelországNo longer taking part
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory ReicherWarsaw, LengyelországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University Of Gdansk
- Trial code
- EU 2024-515061-33-00
- Record updated
- 2025. július 24.
- Original description
Assessment of time to hospitalization for cardiovascular reasons or death from any causeRead full original descriptionShow less
Assessment of time to hospitalization for cardiovascular reasons or death from any cause
Inclusion: 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.
Exclusion: 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.