Screening for early heart failure diagnosis and management using biomarkers and echocardiography

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international, multicentre, randomised-controlled trial aims to implement a targeted screening strategy to identify undiagnosed heart failure in high-risk patients aged 40 and older. Participants will be randomly assigned to either routine care or an investigational arm where they will undergo blood tests for NT-proBNP levels and echocardiography if elevated. The study will pool data from multiple countries, including Denmark, Canada, the USA, Sweden, and Scotland, to analyze the efficacy of this screening approach. The use of advanced echocardiography technology and AI-generated reports aims to enhance the accuracy of heart failure diagnosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female ≥40 years of age
* Informed consent
* Two or more of the following risk factors for heart failure:

  1. 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 \[50% left main stem or \>70% left anterior descending, circumflex or right coronary artery\])
  2. An established diagnosis of diabetes (type 1 or type 2)
  3. Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation)
  4. Previous ischemic or embolic stroke
  5. Peripheral arterial disease (previous surgical or percutaneous revascularisation or a documented stenosis greater than 50% of a major peripheral arterial vessel).
  6. 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).
  7. Regular loop diuretic use (any dose at any dosing interval) for \>30 days.
  8. 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's running

• University of Glasgow
  Glasgow, Scotland, United Kingdom Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Not yet recruiting
• University of British Columbia
  Vancouver, British Columbia, Canada Not yet recruiting
• University of Montreal
  Montreal, Quebec, Canada Not yet recruiting
• Rigshospitalet, Copenhagen University Hospital
  Copenhagen, Denmark Not yet recruiting
• Karolinska University Hospital
  Stockholm, Sweden Not yet recruiting

Study contacts

• Principal investigator: Mark C Petrie, MbChB — University of Glasgow
• Study coordinator: Mark C Petrie, MbChB
• Email: mark.petrie@glasgow.ac.uk
• Phone: +44(0) 141 330 2677

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AI-powered ECG to help diagnose and predict outcomes in heart disease

  Researchers test an AI-enhanced ECG to help diagnose and predict outcomes for people with cardiovascular diseases.

  Recruiting Inha University Hospital · Incheon, Incheon · NCT07856472

• Intrahospital flu vaccine for adults with high cardiovascular risk when admitted for ACS or heart failure

  This study tests whether offering a flu vaccine at the bedside during a hospital stay, along with counseling, increases vaccination rates for adults with acute coronary syndrome or heart failure who are at high cardiovascular risk.

  Recruiting at 2 sites University Hospital of Cologne · Cologne and 1 other locations · NCT07721649

• Dapagliflozin to Improve Exercise and Heart Function in Fontan Patients

  This study tests whether the diabetes drug dapagliflozin can improve exercise capacity and heart function in people who had a Fontan procedure.

  Recruiting Phase 4 The University of Hong Kong · Hong Kong and 1 other locations · NCT07482943

• Vicadrostat versus spironolactone: effects on kidney function and protein markers

  This will test whether vicadrostat or spironolactone, each given with empagliflozin, changes kidney function and blood/urine protein patterns in adults with CKD and heart disease or heart failure.

  Recruiting at 2 sites Phase 2 University Medical Center Groningen · Groningen, Provincie Groningen and 1 other locations · NCT07304817

• Pulmonary Artery Denervation for a specific type of heart and lung pressure problem

  This study tests whether the Enhancor System can safely and effectively help patients with combined pre- and post-capillary pulmonary hypertension due to left heart disease when added to standard therapy.

  Recruiting at 18 sites Pulnovo Medical, Inc. · Tucson, Arizona and 18 other locations · NCT07214376

• Longitudinal Assessment of Cardiac MRI Microstructure in Patients and Healthy People

  This study tests advanced, non-contrast and extended clinical cardiac MRI techniques to see how heart tissue features differ between people with heart disease and healthy individuals.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07081711

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.