RAC study - urinary albumin-to- creatinine ratio: a risk factor in Cardio-Oncology?

Background

Cancer-related cardiovascular toxicities (CTR-CVT) is a complication of cancer therapies that have an impact on cardiovascular morbidity and mortality, as well as on the probability of discontinuation of cardiovascular diseases.

Since the dawn of cardio-oncology, it has been advocated to demonstrate the existence of risk factors for the occurrence of CTR-CVT and in turn to develop cardio-oncological risk scores that predict when a patient is at high risk of presenting some toxicity.

In recent years, different studies have been published that have demonstrated the relationship between Urinary albumin-to-creatinine ratio (UACR) and the occurrence of cardiovascular events: arrhythmias (atrial fibrillation, ventricular arrhythmia), heart failure, coronary arterial disease, arterial stiffness, myocardial capillary disease.

This study aims to assess UACR as a predictor of risk of cardiovascular events in patients who undergo cancer therapy and to utilize it in their follow-up.

Purpose

The primary endpoint is to demonstrate the relationship between elevated UACR and the incidence of cardiovascular events secondary to cancer therapies.

The secondary endpoints are:

To determine the predictive capacity of UACR for early CTR-CVT.

To analyze the correlation between UACR and cardiac biomarkers (troponin and BNP/NT-proBNP).

To identify UACR cut-off points associated with a higher risk of cardiovascular events.

To evaluate the longitudinal evolution of UACR during cancer treatment.

Methods

The RAC Study is a prospective observational cohort study that will enroll 200 patients over 18 years of age with a confirmed diagnosis of cancer who will initiate specific therapy over a period of 12 months.

Patients will be evaluated at baseline with echocardiogram with strain, biomarkers (troponin, BNP or NT-proBNP), UARC, and blood test.

During follow-up, patients will be evaluated with an echocardiogram, including strain, biomarkers, and UARC, every 3 months.

Statistical analysis will include: descriptive statistics, comparison of incidence of CTR-CVT and UACR levels, logistic or Cox regression models adjusted for confounding variables, ROC curves to assess predictive capacity, longitudinal analysis of changes in UACR and CRT-CVT

Conclusions

The RAC Study is an observational, prospective, cohort study whose objective is to demonstrate the relationship between increased levels of UACR and the occurrence of cardiovascular events secondary to cancer treatment. Also, our objective is to demonstrate the utility of UARC as a tool for predicting CRT-CVT and monitoring these patients.