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Proposal 1907

Title of the Proposed Research

Development and validation of a model to predict absolute vascular risk reduction due to intensive blood-pressure targets in individual patients at baseline and after three months

Lead Researcher

F.L.J. Visseren

Affiliation

University Medical Center Utrecht, Utrecht, the Netherlands

Funding Source

Publically Funded Institution

Potential Conflicts of Interest

None

Data Sharing Agreement Date

16 October 2017

Lay Summary

Background and aim: Hypertension, and subsequently blood-pressure reduction are essential components of cardiovascular disease (CVD) prevention. An important part of this blood-pressure reduction entails setting a blood-pressure target, and titrating the medication to achieve this target. Some patients quickly achieve the desired targets, while other patients require multiple visits to the physician, and switching between blood-pressure lowering medications. A large number of models able to predict an individual’s prognosis before the start of therapy exist for patients with cardiovascular disease. These prognostic scores are often calculated prior to an intervention. However, in theory, patients’ prognoses should change after an intervention has been administered. Whether a patient quickly achieves the blood-pressure target, of does not achieve the target after a number of months may contain valuable information relating the prognosis of the patient. We therefore aim the develop both a prognostic model with variables pre-intervention (at baseline), and compare the ability of this model to accurately predict to a model which incorporates variables after approximately 3 months.

Improving patient care: Even among high-risk patients, or patients with cardiovascular disease, there is a significant variability in prognosis. Individualized risk prediction is therefore important for both the patient to understand his or her own risk, and for the doctor when deciding how to approach treatment. Response to a certain treatment, i.e. blood-pressure medication or the setting of blood-pressure targets, could be important factors which could more accurately predict risk than using baseline factors alone.

How will the research be conducted?: The research will be conducted by utilizing data from multiple clinical trials to develop a prognostic model which predicts an individual’s risk of a major cardiovascular event . First, one model using pre-treatment (baseline) variables will be developed. Second, variables measured after approximately 3 months follow-up , will be added to the baseline data. The area under the curve, and calibration differences between these models will be described, as well as the net reclassification index.

Study Data Provided

BI-502.373: Effectiveness and Safety of Ramipril Alone Compared With Telmisartan Alone and in Combination With Ramipril in Patients at High Risk for Cardiovascular Events. Patients Intolerant to Ramipril Were Entered in TRANSCEND, Telmisartan Compared to Placebo.

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.