What this study is
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.
What's being tested
- NT-proBNP
Intervention · DIAGNOSTIC TEST
Patients will undergo an NT-proBNP which will guide their future involvement within the study. Patients with an NT-proBNP of ≥125 pg/mL will undergo transthoracic echocardiogram along with a clinical assessment - any diagnosis of HF will result in patients undergoing referral for initiation of guideline directed medical therapy (for HF).
Study details
- Official title
- Screening for earlY Heart Failure Diagnosis and Management in Primary Care or at HOme Using Natriuretic Peptides and echocardiographY
- Sponsor
- NHS Greater Glasgow and Clyde
- Conditions
- Heart Failure · Cardiovascular Diseases
- Enrolling
- 3,904 people
- Starts
- 2022-12-22
- Est. completion
- 2032-12-21
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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).
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (7)
7 open- Not yet recruiting
6 sites outside the US
University of British Columbia
Vancouver, British Columbia, Canada
- Nathaniel Hawkins · Contactnathawkins@hotmail.com
Not yet recruiting- Not yet recruiting
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark
- Lars Køber · Contactlars.koeber.01@regionh.dk
Not yet recruiting- Not yet recruiting
- Not yet recruiting
University of Glasgow
Glasgow, Scotland, United Kingdom
- Mark C Petrie, MbChB · Contact+44(0) 141 330 2677mark.petrie@glasgow.ac.uk
- F · Contact
Recruiting
Study team
Sponsor
NHS Greater Glasgow and Clyde
Study ID 1
Principal investigator
Mark C Petrie, MbChB
University of Glasgow
Principal investigator
Carolyn SP Lam
Duke-NUS Graduate Medical School
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.