Study of Blood Biomarkers to Detect Heart Failure with Preserved Ejection Fraction in Adults Suspected of Heart Failure, Including Those with Obesity
Led by NHS Greater Glasgow and Clyde · Updated on 2024-02-13
1028
Participants Needed
3
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying patients with suspected heart failure with preserved ejection fraction HFpEF, especially focusing on those with obesity. The study aims to evaluate new ways to identify HFpEF because the commonly used NT-proBNP test is less effective at detecting HFpEF in people with obesity or those with low NT-proBNP levels. This observational study will explore alternative NT-proBNP cut-offs and novel biomarkers to improve diagnosis and understand how common HFpEF is in these groups.
The study will observe patients in primary care who have had NT-proBNP levels tested as part of their routine care for suspected heart failure. Participants will undergo assessments including medical history, physical examination, patient questionnaires, electrocardiograms, echocardiography, and blood and urine biomarker tests. Heart failure experts will use these results and echocardiography findings to diagnose heart failure. The study will include patients grouped by NT-proBNP levels and obesity status to evaluate the utility of different biomarkers.
Participants will be followed over time using medical records to track hospitalizations and deaths for at least 10 years. Researchers will monitor clinical signs, biomarker levels, and heart function through non-invasive testing such as echocardiography. The main outcome is determining the best NT-proBNP cut-offs for diagnosing HFpEF in obese patients, along with evaluating biomarker performance and the prevalence of heart failure in patients with low NT-proBNP. This long-term observation will provide insights into heart failure diagnosis and progression in this population.
CONDITIONS
Brief Title
Biomarkers in Patients With Suspected HFpEF
Research Team
R
Ross Campbell, MBChB
M
Mark Petrie, MBChB
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NT-proBNP sample taken by primary care physician as part of routine care for suspected heart failure
You will not qualify if you...
Unable to consent to inclusion in study due to significant cognitive impairment
Geographical or social reasons preventing attending study centre
Unable to complete study assessments
Patients presenting with acute heart failure or a previous diagnosis of heart failure
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 3 months
Participants undergo clinical history and examination, patient-reported outcome measures, electrocardiography, echocardiography, and biomarker analysis to evaluate heart failure status.
1 to 2 visits depending on assessment needs
Long-term Monitoring
Duration - At least 10 years
Participants are followed passively for a minimum of 10 years using record linkage for hospitalisations or deaths to monitor health outcomes.
No visits required; passive follow-up
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
Exercise testing in heart failure with preserved ejection fraction: an appraisal through diagnosis, pathophysiology and therapy - A clinical consensus statement of the Heart Failure Association and European Association of Preventive Cardiology of the European Society of Cardiology.
How to diagnose heart failure with preserved ejection fraction: the HFA-PEFF diagnostic algorithm: a consensus recommendation from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC).
Burkert Pieske, Carsten Tschöpe, Rudolf A de Boer...
The clinical use of stress echocardiography in non-ischaemic heart disease: recommendations from the European Association of Cardiovascular Imaging and the American Society of Echocardiography.
Patrizio Lancellotti, Patricia A Pellikka, Werner Budts...
Highest Obesity Category Associated With Largest Decrease in N-Terminal Pro-B-Type Natriuretic Peptide in Patients Hospitalized With Heart Failure With Preserved Ejection Fraction.
Joban Vaishnav, Jessica E Chasler, Yizhen J Lee...