NCT01641562: CARDIOTAX

Diagnosis and Prediction of Taxanes Induced Cardiac Dysfunction

Completed Last updated 17 July 2020

What this trial tests

trial in Breast Cancer in 60 participants. Completed in 31 January 2017.

Timeline

1 January 2012

Primary endpoint
30 October 2016

31 January 2017

Quick facts

Lead sponsor	Carol Davila University of Medicine and Pharmacy
Status	Completed
Study type	OBSERVATIONAL
Enrollment	60
Start date	1 January 2012
Primary completion	30 October 2016
Estimated completion	31 January 2017
Sites	1 location across Romania

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Carol Davila University of Medicine and Pharmacy

Who can join

Adults 18 to 80, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Breast cancer represents the most frequent form of neoplasia in women worldwide, being responsible of 1.6% of annual deaths. Therefore, it is a major public health issue and research in this field should be a priority. Taxanes, such as paclitaxel and docetaxel, are extremely powerful antineoplastic drugs, which alone or in association to anthracyclines, increase survival and lower the recurrence rate of cancer, but their use is limited by cardiotoxicity. Cardiotoxicity can appear early or late after therapy, and may vary from subclinical myocardial dysfunction to irreversible heart failure. Currently, cardiac dysfunction induced by taxanes is diagnosed through classical echocardiographic parameters. However, these cannot detect subtle, early changes of cardiac structure and function. Consequently, description of new parameters, which could detect cardiac dysfunction in an early stage, becomes essential for detecting the group of patients at risk for irreversible heart failure. The objectives of the investigators project, in patients with breast cancer treated with taxanes, are to investigate their mechanisms which lead to cardiac dysfunction, to describe new parameters for the early diagnosis of cardiotoxicity, and to define predictive models for cardiotoxicity. Meanwhile, project will publish the results in prestigious journals, leading to an increase of the visibility of Romanian research internationally.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cancer-Induced Cardiac Dysfunction: Mechanisms, Diagnostics, and Emerging Therapeutics in the Era of Onco-Cardiology.
   Saha S, Singh PK, Roy P, Vemuri V, et al · · 2025 · cited 3× · PMID 41097751 · DOI 10.3390/cancers17193225