RecruitingOBSERVATIONAL

A Prospective, Observational, Single Centre Study to Assess the Feasibility of the Data Harvested by the Acorai Intracardiac Pressure Monitoring (ICPM) System in Predicting Prognosis in Patients Discharged From Hospital After Treatment for Acute Decompensated Heart Failure

This study is looking at a new, handheld device called the Acorai Heart Monitor. It's designed to measure pressures inside your heart without needing an invasive procedure. Currently, doctors use a thin tube inserted into your body to get these measurements, which carries risks. The Acorai device, placed on your chest, aims to be a much safer and simpler way to do this. Researchers want to see if the data collected by this device can help predict how well people with heart failure will recover after leaving the hospital, and if it can help identify those who might be at risk of their condition worsening. This could lead to better and earlier care for heart failure patients.

At a glance

Status

Recruiting

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Enrolment target

150

Start

29 Apr 2024

Estimated completion

01 Feb 2027

Heart Failure Decompensated Heart Failure

What is this study about?

Heart failure is a condition where your heart can't pump enough blood around your body. When it gets worse suddenly, it's called 'decompensated heart failure', and often requires a hospital stay. To understand how severe heart failure is and to guide treatment, doctors sometimes need to measure the pressure inside your heart.

Currently, the main way to do this is through an invasive procedure called a 'right heart catheterisation'. This involves inserting a thin tube into a blood vessel, usually in your neck or groin, and guiding it into your heart. While this gives doctors important information, it does carry some risks, like bleeding or infection.

This study is testing a new, non-invasive device called the Acorai Heart Monitor. It's designed to be placed on your chest and measure these heart pressures using advanced sensors, without needing any needles or tubes inside your body. The goal is to see if the information collected by this device can accurately tell doctors about your heart's health and help predict your progress after leaving the hospital. Ultimately, if successful, this could provide a much safer and easier way to monitor people with heart failure.

Key takeaways

This study is testing a new, non-invasive way to measure heart pressures.
The device, Acorai Heart Monitor, sits on your chest and collects data.
It aims to help doctors better understand and predict the course of heart failure.
This could offer a safer alternative to current invasive procedures.
Participation involves a single measurement before hospital discharge and a year of follow-up.

Who may be eligible?

To be considered for this study, you must be an adult (18 years or older) who has recently been in the hospital for heart failure that needed special intravenous (IV) medication to help. You should also be well enough to go home from the hospital.

It's important that you are willing and able to follow the study instructions and attend any necessary appointments. You'll also need to be able to understand and sign a consent form, showing you agree to take part.

However, if you are pregnant, you won't be able to join this study. Also, the study doctor might decide it's not in your best interest to participate for other medical reasons.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently been in hospital for heart failure that needed intravenous medication?
Are you medically fit to go home from the hospital?
Are you willing to follow study instructions and attend appointments?
Can you provide written consent to join the study?
Are you currently not pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, a new device called the Acorai Heart Monitor will be used to take measurements. This is a handheld device that rests on your chest, along with a small wrist strap, for about five minutes while you lie down. This will happen before you leave the hospital. The study doctors will collect this information and continue to keep track of your health for one year after your hospital discharge to see how you are doing.

Potential risks and benefits

Taking part in this study may offer the potential benefit of contributing to research that could develop a safer and easier way to monitor heart failure patients in the future. The Acorai device is non-invasive, meaning it doesn't involve any needles or tubes, so the risks are expected to be very low and are generally related to the sensors. We understand that medical decisions are personal, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Harefield Hospital
Verified postcode
Uxbridge, United Kingdom· Recruiting

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood as well as it should. It can lead to tiredness and shortness of breath.

What is 'decompensated heart failure'?

This is when your heart failure suddenly gets worse, often needing hospital treatment like intravenous (IV) medication.

What does 'non-invasive' mean?

It means the test or device doesn't go inside your body, like a blood pressure cuff or an ECG.

Will this device replace my regular heart failure treatment?

No, this device is for gathering information for research. It will not replace your current or future heart failure treatments.

How long does taking part in the study last?

You will have measurements taken before you leave the hospital, and then your health will be monitored for about one year after that.

How to find out more

Owais Dar, MB ChB MD Res

o.dar@rbht.nhs.uk 01895828933 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.