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Article History

Received: 21 November 2019

Accepted: 20 March 2020

First Online: 16 April 2020

Ethics approval and consent to participate

: The “MASS VI-(HF)” research protocol was developed in accordance with the principles of the Declaration of Helsinki and according to the laws and regulations of our country. The Ethics Committee of the Heart Institute of the Hospital das Clínicas of the Medical School of the University of São Paulo approved the study protocol. The principal investigator has and will continue to obtain written informed consent from study participants. These consents are available from the corresponding author on request. On the consent form, participants will be asked if they agree to the use of their data should they choose to withdraw from the trial. Participants will also be asked for permission for the research team to share relevant data with people from the Universities taking part in the research or from regulatory authorities, where relevant. Patients were informed that they will be randomized to surgery with extracorporeal circulation or drug treatment.All data collected during the course of the research will be kept strictly confidential and only accessed by members of the trial team. Participants will be allocated an individual trial identification number. All data will be stored in a secure database, accessible only to the Trial Steering Committee. Anonymized trial data could be shared with other researchers to enable international prospective meta-analyses. Any data required to support the protocol can be supplied on request.All named authors adhere to the authorship guidelines of Trials. All authors have agreed to publication.The Project Management Group will review the trial every 6 months, and at any time if any other concern is observed during the study. An independent data monitoring committee will review outcomes for every 50 patients randomized in the study. The Hospital Ethics Committee will also routinely review the study every 6 months and state specific recommendations as needed.

: Not applicable.

: The authors declare that they have no competing interest.