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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

SYMPHONY-HF Trial 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.

SYMPHONY-HF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a stroke caused by a clot.

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My heart condition is persistent or permanent atrial fibrillation.

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I have had surgery or a procedure for blocked arteries in my legs.

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I have had a heart attack or surgery/intervention for blocked heart arteries.

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I have chronic kidney disease with specific kidney function levels.

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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.

SYMPHONY-HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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 more

SYMPHONY-HF Trial 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

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

NHS Greater Glasgow and ClydeLead Sponsor

273 Previous Clinical Trials

307,986 Total Patients Enrolled

University of GlasgowOTHER

337 Previous Clinical Trials

24,955,233 Total Patients Enrolled

National Heart Centre SingaporeOTHER

72 Previous Clinical Trials

7,447,364 Total Patients Enrolled

Media Library

Investigational arm Clinical Trial Eligibility Overview. Trial Name: NCT05919342 — N/A

Cardiovascular Disease Research Study Groups: Routine care arm, Investigational arm

Cardiovascular Disease Clinical Trial 2023: Investigational arm Highlights & Side Effects. Trial Name: NCT05919342 — N/A

Investigational arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05919342 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap for participants in this experiment?

"The sponsor, AstraZeneca, will need to recruit 3904 participants that meet the inclusion criteria for this trial. These patients can be found at two locations in Canada: University of British Columbia in Vancouver and University of Montreal in Montréal."

Answered by AI

Is this trial currently open for enrolment?

"Affirmative, the trial is actively seeking participants. According to clinicaltrials.gov, this study was first presented on December 22nd 2022 and has been recently revised on June 22nd 2023. In total, 3904 volunteers are needed at 7 distinct medical hubs."

Answered by AI

How many facilities are currently running this research program?

"Currently, this trial is being conducted at 7 different locations around the world. These include Vancouver, Montréal and Copenhagen as well as 4 other cities. To minimize travel demands enrolled patients should select a site nearest to them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Screening for earlY Heart Failure Diagnosis and Management in Primary Care or at HOme Using Natriuretic Peptides and echocardiographY "SYMPHONY-HF"". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05919342.