RecruitingNot ApplicableNCT05919342

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

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

Enrollment

3,904 participants

Start Date

Dec 22, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 Years

Inclusion Criteria11

  • 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 Criteria4

  • 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

Interventions

DIAGNOSTIC_TESTNT-proBNP

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).


Locations(7)

Cleveland Clinic

Cleveland, Ohio, United States

University of British Columbia

Vancouver, British Columbia, Canada

University of Montreal

Montreal, Quebec, Canada

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark

Karolinska University Hospital

Stockholm, Sweden

Uppsala University

Uppsala, Sweden

University of Glasgow

Glasgow, Scotland, United Kingdom

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NCT05919342


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