Cardiac safety clinical trials

Demonstrated Expertise in Multiple Study Types. Collection of ECGs at multiple time points under tightly controlled settings that target a broad range of doses early in development.

Polarization studies. Targeted Patient Recruitment. Ado trastuzumab emtansine TDM1 : 3. Outcome Measures. If a patient already received part of the planned HER2 targeted therapy prior to enrollment in this trial, planned oncologic therapy will be achieved when a total of 1 year is completed.

In the metastatic setting: cessation of treating regimen due to progressive disease or non-cardiac toxicity or non-cardiac death. Hold is defined as any delay or discontinuation of HER2 targeted therapy due to cardiac toxicity. One cycle of HER2 targeted therapy will be considered 3 weeks. For patients who had a hold and resumed HER2 targeted therapy, duration of treatment hold will be described.

Eligibility Criteria. Patients of childbearing potential must implement contraceptive measures during study treatment and for 7 months after last dose of treatment drug and must have negative urine or serum pregnancy test within 7 days prior to registration.

History of significant neurologic or psychiatric disorders including psychotic disorders or dementia that would prohibit the understanding and giving of informed consent. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials. More Information. Breast Cancer Res Treat. Epub Mar 9. Epub Mar Cardiac electrophysiology effects, especially as manifested by changes in the QT interval, have been studied. None of the three agents are dangerously associated with QTc prolongation, although vardenafil has a warning for patients at risk for QTc prolongation.

In evaluating cardiovascular adverse events in clinical trials, no signal to danger can be convincingly cited. Indeed, with the vasodilator effects of these drugs, many studies point to the improved exercise tolerance and coronary dilation in patients taking PDE5 inhibitors.

Cardiac Safety Leadership BioTel Research has been a leader in the cardiac core lab industry since the s. Electrocardiography ECG We offer all ECG reading methodologies that might be requested, using varying degrees of automation and manual application of cardiac expertise.

Holter Monitoring Holter recordings , , hour, and up to 7 days are analyzed first by a cardiovascular medical doctor, then reviewed and authorized by a board-certified cardiologist or electrophysiologist, if required. Subscribe to our newsletter. Subscribe now.