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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515061-33-00
Acronym
NBK531/1/2022
Enrollment
485
Registered
2024-12-09
Start date
2024-03-22
Completion date
2025-12-05
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive-anxiety states in people with heart failure with preserved ejection fraction

Brief summary

Time to hospitalization for cardiovascular reasons or death from any cause

Detailed description

a. time to hospitalization for any cause, b. time to death for any cause, c. time to hospitalization for cardiovascular causes, d. time to death for cardiovascular causes, e. total time to death or hospitalization for any cause f. Change in the PHQ-9 and GAD-7 scale score from the last measurement before drug administration g. SF-12 scale score mental h.g. SF-12 mental score h. 8a. KCCQ-12 score 8b. NYHA class 8c. CCS class i. Level of biomarkers related to endothelial function

Interventions

DRUGAsentra
DRUG50 mg
DRUGPL1

Sponsors

Medical University Of Gdansk
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to hospitalization for cardiovascular reasons or death from any cause

Secondary

MeasureTime frame
a. time to hospitalization for any cause, b. time to death for any cause, c. time to hospitalization for cardiovascular causes, d. time to death for cardiovascular causes, e. total time to death or hospitalization for any cause f. Change in the PHQ-9 and GAD-7 scale score from the last measurement before drug administration g. SF-12 scale score mental h.g. SF-12 mental score h. 8a. KCCQ-12 score 8b. NYHA class 8c. CCS class i. Level of biomarkers related to endothelial function

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026