Key result
RED-CVD evaluates if early diagnosis increases CVD detection vs usual care in T2D or COPD.
Why the study?
Early stages of CVD cause non-specific symptoms that are easily missed, yet proactive diagnosis in high-risk patients with type 2 diabetes or COPD could enable earlier intervention.
Does an early diagnosis strategy using symptom questionnaires, natriuretic peptide measurement, and electrocardiography increase the detection of cardiovascular disease in primary care patients with type 2 diabetes or COPD?
RCT (n=1,300)
cluster
Yes
Does an early diagnosis strategy using symptom questionnaires, natriuretic peptide measurement, and electrocardiography increase the detection of cardiovascular disease in primary care patients with type 2 diabetes or COPD?
This protocol describes a cluster randomized trial to determine if a proactive screening strategy improves the early detection of cardiovascular disease in high-risk primary care patients with type 2 diabetes or COPD.
INTRODUCTION: The early stages of chronic progressive cardiovascular disease (CVD) generally cause non-specific symptoms that patients often do not spontaneously mention to their general practitioner, and are therefore easily missed. A proactive diagnostic strategy has the potential to uncover these frequently missed early stages, creating an opportunity for earlier intervention. This is of particular importance for chronic progressive CVDs with evidence-based therapies known to improve prognosis, such as ischaemic heart disease, atrial fibrillation and heart failure.Patients with type 2 diabetes or chronic obstructive pulmonary disease (COPD) are at particularly high risk of developing CVD. In the current study, we will demonstrate the feasibility and effectiveness of screening these high-risk patients with our early diagnosis strategy, using tools that are readily available in primary care, such as symptom questionnaires (to be filled out by the patients themselves), natriuretic peptide measurement and electrocardiography. METHODS AND ANALYSIS: The Reviving the Early Diagnosis-CVD trial is a multicentre, cluster randomised diagnostic trial performed in primary care practices across the Netherlands. We aim to include 1300 (2×650) patients who participate in a primary care disease management programme for COPD or type 2 diabetes. Practices will be randomised to the intervention arm (performing the early diagnosis strategy during the routine visits that are part of the disease management programmes) or the control arm (care as usual). The main outcome is the number of newly detected cases with CVDs in both arms, and the subsequent therapies they received. Secondary endpoints include quality of life, cost-effectiveness and the added diagnostic value of family and reproductive history questionnaires and three (novel) biomarkers (high-sensitive troponin-I, growth differentiation factor-15 and suppressor of tumourigenicity 2). Finally newly initiated treatments will be compared in both groups. ETHICS AND DISSEMINATION: The protocol was approved by the Medical Ethical Committee of the University Medical Center Utrecht, the Netherlands. Results are expected in 2022 and will be disseminated through international peer-reviewed publications. TRIAL REGISTRATION NUMBER: NTR7360.
No takes yet. Share an insight, caveat, or question.
Groenewegen et al. (2021) conducted an RCT in type 2 diabetes or COPD (n=1,300). early diagnosis strategy vs. care as usual was evaluated on number of newly detected cases with CVDs and subsequent therapies received. The RED-CVD cluster randomized trial will evaluate whether an early diagnosis strategy increases the detection of cardiovascular disease compared to usual care in 1300 patients with T2D or COPD.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: