Early Detection and IntervenTion in Undetected Heart Failure (EDIT-HF) trial
Description: Heart failure (HF) is thought to affect 1-2% of people in the modern societies, however, the true prevalence remains largely unknown. At the same time, undetected HF is prevalent in high-risk groups, including chronic obstructive pulmonary disease (COPD), diabetes, hypertension, atrial fibrillation, obesity, and geriatric settings. A study analysing the prevalence of HF among high risk patients without HF history found that up to 34% of these patients fulfil the diagnostic criteria for HF with HF with preserved left ventricular ejection fraction (HFpEF) being dominant.This epidemic of undetected HF is complex and multifactorial. On the one hand, high-risk comorbidities share similar clinical pictures (e.g. dyspnoea is a cornerstone symptom of COPD, obesity and HF), and the vigilance for comorbidities in patients with already established diagnosis is low. On the other hand, gradually developing dyspnoea and reducing physical capacity in older patients are often falsely attributed to the natural course of aging. The fact that 44% of patients diagnosed with HF in acute setting had at least 1 HF-attributed clinical symptom within a year prior to decompensation supports this assumption. Even more, 2 out of 3 newly diagnosed HF patients with natriuretic peptide level check within a year had an abnormal value; despite that, the diagnosis was not made on time. Also, <15% of patients with acute HF diagnosis undergo prior natriuretic peptide screening, suggesting an opportunity for earlier disease detection. Since early diagnosis of HF leads to timely initiation of evidence-based interventions, the current gap in HF care adds to the growing number of HF hospitalizations, unacceptably high death rates, and poor quality of life of patients living with undetected HF. This is especially true in the context of modern HF treatment with evidence-based measures, improving hard outcome in patients with both reduced and preserved left ventricular ejection fraction. Taken the high prevalence of undetected HF into account, it becomes obvious that state-of-the-art knowledge generated by modern clinical trials are poorly applied. This leads to enormous health care costs, primarily related to HF hospitalizations that could have been avoided.This prospective, stepped-wedge, randomized, controlled, interventional trial is designed to test whether diagnostic screening of consecutive high-risk patients without prior HF diagnosis and subsequent referral of newly detected HF patients to a HF clinic improve HF hospitalization-free survival. The present study will be conducted in a step-wedged manner. This modern design will allow to include all patients and avoid selection bias. During the implementation phase, screening will be performed based on the recent ESC HF diagnostic algorithm. Patients with at least one clinical symptom of HF (e. g. dyspnea, ankle swelling, fatigue) will undergo plasma natriuretic peptide measurement. If detected plasma NT-proBNP level will be =125 pg/mL or BNP =35 pg/mL, the patient will be referred to local HF clinic for specialized assessment, treatment adjustment and follow-up, based on current best clinical practice. The control patients will receive the usual care. The following facilities where chosen as potential candidates to participate in the study, based on previously reported high prevalence of undetected HF in these populations: diabetes, COPD, geriatric, hypertension, arrhythmia clinics, major non-cardiovascular surgery and non-invasive coronary artery disease tracks. Since the present research question concentrates on testing of a concept with high public health need and has no interest in a specific treatment method, it attracts no attention from the industry and can only be conducted as an investigator initiated clinical trial, to fill this enormous knowledge gap, potentially changing the thresholds of diagnostic vigilance in Switzerland and world-wide.
Amount: CHF 5,000
Funding type: research
Funder scheme: IICT - PPI Preparatory Grant
Start date: 2023-07-01
End date: 2023-10-31
Investigator: Mueller, Christian
Institution: University of Basel – BS
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Funded outputs count: 0
Funder award ID: 221726
OpenAlex ID: G8949332113