About the study

This study evaluates the effects of sertraline on depressive and anxiety symptoms, endothelial function and prognosis in patients with heart failure with preserved ejection fraction (HFpEF).

The project aims to determine whether antidepressant treatment can simultaneously improve patients’ mental health and positively influence the course of heart disease.

What is HFpEF?

Heart failure with preserved ejection fraction (HFpEF) is a form of heart failure in which symptoms of cardiac dysfunction occur despite preserved pumping function of the heart.

The condition is associated with a high risk of hospitalisation and reduced quality of life, and currently there is no clearly effective targeted therapy.

The impact of depression and anxiety

Depression and anxiety disorders are common among patients with HFpEF and may significantly worsen prognosis.

These conditions affect not only quality of life but also the course of cardiovascular disease, increasing the risk of hospitalisation and mortality.

Why sertraline?

Sertraline is a selective serotonin reuptake inhibitor (SSRI) used in the treatment of depressive and anxiety disorders.

In addition to its psychiatric effects, sertraline may exert additional biological actions, including modulation of inflammatory responses and improvement of endothelial function and microcirculation.

Study assessments

The study evaluates, among others:

• severity of depressive symptoms (PHQ-9);
• severity of anxiety symptoms (GAD-7);
• quality of life (SF-12);
• endothelial function and biomarkers;
• all-cause and cardiovascular mortality;
• number of hospitalisations;
• clinical status according to NYHA classification and KCCQ.

Study design

Participants are randomly assigned in a 2:1 ratio to receive either sertraline or placebo.

The study allows evaluation of both short-term and long-term treatment effects.

Study population

The study plans to enrol 495 patients aged 60–85 years with HFpEF and clinically significant depressive or anxiety symptoms (PHQ-9 ≥ 10 or GAD-7 ≥ 10).

Detailed eligibility criteria should be confirmed directly with the study centre.

Study objectives

The objective of the study is to evaluate the effects of sertraline on reducing depressive and anxiety symptoms and improving prognosis in patients with HFpEF.

The project also seeks to determine whether improvements in mental health translate into reduced mortality and fewer hospitalisations.

Organisational information

The project is funded by the Polish state budget through the Medical Research Agency (MRA), project number: 2021/ABM/02/00024.

Project duration: 01 December 2021 – 31 October 2027.

Total project value: PLN 9,944,017.55.