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NT-proBNP Screening for Heart Failure (SYMPHONY-HF Trial)
N/A
Recruiting
Led By Carolyn SP Lam
Research Sponsored by NHS Greater Glasgow and Clyde
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previous ischemic or embolic stroke
Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation)
Must not have
Inability to give informed consent e.g., due to significant cognitive impairment
Current renal replacement therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Summary
This trial studies a better way to screen for hidden heart failure in people at high risk.
Who is the study for?
This trial is for adults over 40 with persistent atrial fibrillation and a history of stroke, plus two or more risk factors like coronary artery disease, diabetes, peripheral arterial disease, chronic kidney disease, regular use of loop diuretics, or COPD. It's not for those who can't consent, are on renal replacement therapy, have known heart failure or other conditions that may limit survival during the study.Check my eligibility
What is being tested?
SYMPHONY-HF aims to test if screening high-risk patients using NT-proBNP (a marker in the blood) and echocardiography can help detect undiagnosed heart failure early. Participants will be randomly assigned to receive this targeted screening strategy.See study design
What are the potential side effects?
Since this trial focuses on screening strategies rather than medication interventions directly treating heart failure, side effects are primarily related to the diagnostic procedures rather than drug-related adverse reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a stroke caused by a clot.
Select...
My heart condition is persistent or permanent atrial fibrillation.
Select...
I have had surgery or a procedure for blocked arteries in my legs.
Select...
I have had a heart attack or surgery/intervention for blocked heart arteries.
Select...
I have chronic kidney disease with specific kidney function levels.
Select...
I have been diagnosed with diabetes.
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I have been taking water pills regularly for over a month.
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I am 40 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am able to understand and agree to the study's procedures and risks.
Select...
I am on dialysis.
Select...
I have been diagnosed with heart failure before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diagnosis of heart failure within 6 months
Secondary outcome measures
Diagnosis of HFrEF within 6 months
People diagnosed with HFrEF receiving GDMT within 6 months
Other outcome measures
All-cause mortality at 1 year
All-cause mortality at 2 years
All-cause mortality at 5 years
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Investigational armExperimental Treatment1 Intervention
Patients in this arm will have a blood sample performed for measurement of N-terminal prohormone of B-type natriuretic peptide (NT-proBNP). Patients with an elevated Roche NT-proBNP (≥125 pg/mL) will undergo a transthoracic echocardiogram, clinical examination for signs of HF, HF symptom assessment, an ECG). Patients will undergo echocardiography with a CE-marked, FDA-approved handheld point of care (POC) EchoNous echocardiogram device in all countries. The US2.ai algorithm (which is also CE-marked and FDA-approved) will generate an AI-automated echocardiogram report.
Group II: Routine care armActive Control1 Intervention
Patients in this arm will undergo routine care. They will be managed and followed up as per routine clinical care. They will be remotely monitored for HF events by follow up through electronic records and routinely collected data.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NT-proBNP
2019
N/A
~90
Find a Location
Who is running the clinical trial?
NHS Greater Glasgow and ClydeLead Sponsor
278 Previous Clinical Trials
301,816 Total Patients Enrolled
University of GlasgowOTHER
342 Previous Clinical Trials
24,957,158 Total Patients Enrolled
National Heart Centre SingaporeOTHER
72 Previous Clinical Trials
7,447,364 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to understand and agree to the study's procedures and risks.I have had surgery or a procedure for blocked arteries in my legs.I have had a heart attack or surgery/intervention for blocked heart arteries.I have been diagnosed with COPD.I have chronic kidney disease with specific kidney function levels.I have had a stroke caused by a clot.My heart condition is persistent or permanent atrial fibrillation.I have been diagnosed with diabetes.You have two or more factors that increase the risk of heart failure.I have been taking water pills regularly for over a month.I am on dialysis.I have been diagnosed with heart failure before.I am 40 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Routine care arm
- Group 2: Investigational arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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