Screening for earlY Heart Failure Diagnosis and Management in Primary Care or at HOme Using Natriuretic Peptides and echocardiographY
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 3,904
- Locations
- 9
- Primary Endpoint
- Diagnosis of heart failure within 6 months
Study Overview
Brief Summary
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.
Detailed Description
The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure (HF) in high-risk patients.
Participants will be recruited from 5-countries (Denmark, Canada, United States of America, Sweden and Scotland). Individual patient data from similar national randomised controlled trials that are independently powered for different efficacy endpoints will be pooled, harmonised and analysed.
After agreeing to consent, patients will be randomised to one of two arms:
"Routine care arm" - 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.
OR
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Diagnosis of heart failure within 6 months
Time Frame: 6 months
Secondary Outcomes
- Diagnosis of HFrEF within 6 months(6 months)
- People diagnosed with HFrEF receiving GDMT within 6 months(6 months)