Screening for earlY Heart Failure Diagnosis and Management in Primary Care or at HOme Using Natriuretic Peptides and echocardiographY "SYMPHONY-HF"
Recruiting · NCT05919342 · Interventional (participants receive a specific treatment) · Lead sponsor: NHS Greater Glasgow and Clyde
View the official record on ClinicalTrials.gov →Interventions studied
NT-proBNP
What this trial is about
This is an international prospective, multicentre, unblinded, randomised-controlled trial. The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure in high-risk patients.
Who can take part
Age range
40 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male or female ≥40 years of age
- Informed consent
- Two or more of the following risk factors for heart failure:
- Coronary artery disease (either a previous documented type 1 myocardial infarction or coronary artery bypass grafting or percutaneous coronary intervention or documented stenosis of an epicardial coronary artery \[50% left main stem or \>70% left anterior descending, circumflex or right coronary artery\])
- An established diagnosis of diabetes (type 1 or type 2)
- Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation)
- Previous ischemic or embolic stroke
- Peripheral arterial disease (previous surgical or percutaneous revascularisation or a documented stenosis greater than 50% of a major peripheral arterial vessel).
- Chronic kidney disease (defined as an estimated glomerular filtration rate \<60mL/min/1.73m2 or eGFR 60-90mL/min/1.73m2 and UACR \>300mg/g).
- Regular loop diuretic use (any dose at any dosing interval) for \>30 days.
- COPD (evidenced by one of the following: PFTs showing airway obstruction, diagnosis by respiratory physician, CT scan reporting presence of emphysema or treatment with national guideline advocated COPD therapy).
Exclusion criteria
- Inability to give informed consent e.g., due to significant cognitive impairment
- Previous documented diagnosis of heart failure
- Current renal replacement therapy
- Anyone who, in the investigators' opinion, is not suitable to participate in the trial for other reasons e.g., a diagnosis which may compromise survival over the study period
Where it is running
7 locations listed across 1 US state.
- Cleveland Clinic - Cleveland, Ohio, United States
- Rigshospitalet, Copenhagen University Hospital - Copenhagen, Denmark
- Karolinska University Hospital - Stockholm, Sweden
- Uppsala University - Uppsala, Sweden
- University of British Columbia - Vancouver, British Columbia, Canada
- University of Montreal - Montreal, Quebec, Canada
- University of Glasgow - Glasgow, Scotland, United Kingdom