The effect of sertraline on anxiety-depressive symptoms, endothelial dysfunction and biomarkers in heart failure patients with preserved ejection fraction
This research is investigating if a medication called sertraline, often used for anxiety and depression, can help people who have a specific type of heart failure. This type of heart failure is called 'heart failure with preserved ejection fraction' – meaning the heart still pumps blood well, but it struggles to relax properly. The study wants to find out if taking sertraline can make a difference to how often these patients need to go to hospital for heart-related issues, or if it changes their risk of death. Researchers will also look at how participants' anxiety and depression symptoms change, as well as their general quality of life and some blood markers. The goal is to see if this existing medicine could offer a new way to help people manage their heart condition better, especially if they are also struggling with anxiety or low mood.
At a glance
What is this study about?
Imagine you have a type of heart failure where your heart still pumps blood out effectively, but it can't quite relax properly between beats. This is called 'heart failure with preserved ejection fraction.' It can make you feel tired, breathless, and sometimes anxious or down. This study is looking into whether a medicine called sertraline, which is commonly used to help with anxiety and depression, could also benefit people with this heart condition.
The main aim of this research is to see if sertraline can reduce the chances of someone with this heart condition needing to go into hospital for heart-related problems, or reduce their risk of dying from any cause. Researchers will also be checking to see if sertraline helps improve symptoms of anxiety and depression, and if it makes a difference to how people feel about their overall quality of life. They will also measure certain substances in the blood to see if the medicine has an effect on the lining of blood vessels.
Ultimately, this study is trying to understand if a medicine that's already used for mental well-being might also play a role in improving the physical health and quality of life for people living with heart failure with preserved ejection fraction. It's about finding new ways to help patients feel better and stay healthier.
Key takeaways
- The study looks at sertraline for heart failure patients with anxiety/depression.
- It aims to see if the medicine reduces hospital visits or improves well-being.
- Participants will take sertraline tablets and have regular health checks.
- Both physical health (heart function) and mental health (anxiety/mood) are being assessed.
- This is a Phase III study, meaning it's a larger trial to confirm earlier findings.
Who may be eligible?
To take part in this study, you need to be an adult, aged 18 or older. Both men and women are welcome.
The study is specifically for people who have been diagnosed with a type of heart failure called 'heart failure with preserved ejection fraction.' This means your heart is still able to pump blood out well, but it might not relax as it should.
Crucially, you would also need to be experiencing symptoms of anxiety or depression. The study is particularly interested in how sertraline helps people who have both this heart condition and mental health symptoms.
- Are you 18 years old or older?
- Have you been diagnosed with 'heart failure with preserved ejection fraction'?
- Are you currently experiencing symptoms of anxiety or depression?
- Are you able to take tablet medication?
- Are you willing and able to attend regular study appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would be taking a medicine called Asentra (which contains sertraline), in a 50 mg tablet form. You would take this tablet regularly, as instructed by the study team. The study involves several visits to the clinic, where you would have health checks, blood tests, and answer questionnaires about how you are feeling, both physically and mentally.
These questionnaires, like the PHQ-9, GAD-7, SF-12, and KCCQ-12, help the doctors understand your mood, general health, and how your heart condition is affecting your daily life. You'll also have a physical examination to check your heart health, including your NYHA and CCS class, which describe how much your heart failure symptoms affect your daily activities. The study team will be monitoring you closely throughout to see how the medicine is affecting you and your health. The total duration of the study would be discussed with you, but it would involve regular follow-up over a period of time to track your progress.
Potential risks and benefits
Locations (1)
- —Poland
Common questions
What is 'heart failure with preserved ejection fraction'?
It's a type of heart failure where your heart still pumps blood out well, but it struggles to relax properly between beats, which can cause symptoms like breathlessness.
What is sertraline?
Sertraline is a common medicine often prescribed to help people with anxiety and depression.
Will I definitely get sertraline if I join?
In some studies, participants might receive the study medicine, while others might receive a dummy pill (placebo) or another standard treatment. The study team will explain this to you.
How long does the study last?
The study will involve regular check-ups over a period of time to track your health. The exact duration will be discussed by the study team.
Do I have to pay to be in the study?
No, you should not have to pay to participate in a clinical trial. All study-related care and medication are typically provided free of charge.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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