RecruitingNAINTERVENTIONAL

Screening for earlY Heart Failure Diagnosis and Management in Primary Care or at HOme Using Natriuretic Peptides and echocardiographY "SYMPHONY-HF"

The SYMPHONY-HF study aims to find the best way to diagnose and manage heart failure early in people who might be at higher risk. Researchers from several countries are comparing two groups of people. One group receives usual care from their doctor. The other group has a special blood test called NT-proBNP. If this blood test shows higher levels, they'll then have a heart scan (echocardiogram) and other checks. The idea is to see if finding heart failure sooner can lead to better outcomes. This study will help us understand if targeted screening can improve how we care for people with undiagnosed heart failure.

At a glance

Status

Recruiting

Phase

Sponsor

NHS Greater Glasgow and Clyde

Enrolment target

3,904

Start

22 Dec 2022

Estimated completion

21 Dec 2032

Heart Failure Cardiovascular Diseases

What is this study about?

Heart failure is a condition where your heart doesn't pump blood around your body as well as it should. It can be caused by various health problems, and finding it early is important for managing it effectively. This study, called SYMPHONY-HF, is looking at whether a specific screening approach can help doctors find heart failure in people who are at high risk, but haven't been diagnosed yet. The hope is that by identifying the condition earlier, people can get the right treatment and support much sooner.

Researchers are involved from several countries, including the UK (Scotland), Denmark, Canada, the United States, and Sweden. They are recruiting people who are considered to have a higher chance of developing heart failure. Some participants will receive the usual care from their doctors. Others will be in the 'investigational arm', which means they'll have an extra blood test called NT-proBNP. This blood test can indicate if your heart is working harder than it should. If the levels are high, they will then have a special heart scan, called an echocardiogram, along with some other heart checks. This scan helps doctors see how well your heart is pumping.

The study will compare the health of both groups over time, looking for any differences in heart failure events. By doing this, the researchers want to see if this targeted screening strategy leads to earlier diagnoses and ultimately helps people manage their heart health better. It's about empowering healthcare professionals to identify and support people with heart failure as soon as possible.

Key takeaways

Symphony-HF is studying early heart failure diagnosis.
Compares standard care to a new screening approach.
Uses a blood test (NT-proBNP) and heart scan (echocardiogram).
Aims to find heart failure sooner in high-risk individuals.
Involves researchers from multiple countries, including the UK.
Participation helps improve future heart failure management.

Who may be eligible?

To join this study, you need to be at least 40 years old. You also need to have at least two specific risk factors for heart failure. These risk factors include things like having had a previous heart attack or a procedure like a bypass, having diabetes, certain types of irregular heartbeat (atrial fibrillation), a past stroke, or problems with blood flow in your legs. Other risk factors include certain kidney problems, regularly taking water tablets (diuretics), or having a lung condition called COPD.

There are some reasons why you might not be able to participate. For example, if you've already been diagnosed with heart failure, or if you're on kidney dialysis. Also, if the doctors think that joining the study wouldn't be safe or appropriate for you due to other health conditions that might unfortunately affect your survival during the study period, you wouldn't be able to take part. It's important that you can understand and agree to participate yourself.

Quick self-check

Are you 40 years old or older?
Do you have two or more of these risk factors: history of heart attack/procedures, diabetes, certain irregular heartbeats, a past stroke, leg artery disease, kidney problems, regular diuretic use, or COPD?
Have you *not* been previously diagnosed with heart failure?
Are you *not* currently on kidney dialysis?
Are you able to provide your own informed consent?

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'll first be asked to read and sign a consent form. Then, you'll be randomly assigned to one of two groups. If you're in the 'routine care' group, you'll continue to see your own doctor and receive your usual medical care, just as you would normally. The study will mainly follow your health through your electronic medical records.

If you're in the 'investigational' group, you'll have an additional blood test to measure something called NT-proBNP. If the amount of NT-proBNP in your blood is above a certain level, you'll then have a heart scan called an echocardiogram (similar to an ultrasound of your heart). This scan might be done using a special handheld device that uses artificial intelligence to help interpret the results. You'll also have a physical examination and answer questions about any heart failure symptoms. In Scotland, everyone in this group will also have a standard heart scan. If these tests suggest you have heart failure, you'll be referred to specialists for follow-up care. The study will monitor your health over time using your medical records and other routine information.

Potential risks and benefits

Participating in this trial could offer the benefit of potentially identifying heart failure earlier if you are in the investigational arm, which could lead to earlier treatment and management. For those in the routine care arm, the main benefit is contributing to valuable research that could help others in the future. The risks for both groups are generally low, as the blood test is routine, and the heart scan is a non-invasive procedure, similar to an ultrasound scan. However, as with any medical study, there's always a small chance of unexpected events, though these are typically minimal for observational screening. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (7)

Cleveland Clinic
Cleveland, United States· Not yet recruiting
University of British Columbia
Vancouver, Canada· Not yet recruiting
University of Montreal
Montreal, Canada· Not yet recruiting
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark· Not yet recruiting
Karolinska University Hospital
Stockholm, Sweden· Not yet recruiting
Uppsala University
Uppsala, Sweden· Not yet recruiting
University of Glasgow
Glasgow, United Kingdom· Recruiting

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood as effectively as it should. It doesn't mean your heart has stopped, but it might struggle to meet your body's needs.

What is NT-proBNP?

NT-proBNP is a substance found in your blood. Higher levels can indicate that your heart is working harder or under strain, which can be a sign of heart failure.

What is an echocardiogram?

An echocardiogram is a type of ultrasound scan that uses sound waves to create moving pictures of your heart. It helps doctors see how well your heart is pumping and if there are any problems with its structure.

Will I know which group I'm in?

Yes, this is an 'unblinded' study, meaning you will know if you are in the routine care group or the group having extra tests. Your doctor will also know.

What happens if I'm diagnosed with heart failure?

If the study tests suggest you have heart failure, you will be referred for appropriate follow-up and care by heart specialists, just as you would under normal medical practice.

How to find out more

Mark C Petrie, MbChB

mark.petrie@glasgow.ac.uk +44(0) 141 330 2677 Official trial record

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