Active Projects

INfluenza Vaccine to Effectively Stop cardioThoracic Events and Decompensated heart failure (INVESTED) Data Coordinating Center (1 U01 HL130204 02/15/2016-01/31/2021)

The INVESTED trial is an NHLBI-funded study designed to determine which of two formulations of influenza vaccine - the standard dose quadrivalent influenza vaccination or an investigational higher dose trivalent influenza vaccination - is more effective in reducing deaths and cardiopulmonary hospitalizations in individuals over 18 years of age with at least one heart disease risk factor as well as a history of heart attack (within the past year) or hospitalization for heart failure (within the past 2 years).

Principal Investigator DCC: KyungMann Kim, PhD, University of Wisconsin-Madison
Co-Principal Investigators CCC: Scott Solomon, MD, Brigham & Women’s Hospital
Orly Vardeny, PharmD, University of Minnesota
ClinicalTrials.gov Identifier: NCT02787044
Target Enrollment: 9,300
Study Start Date: August 2016
Estimated Completion Date: February 2021
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)

The INVESTED Data Coordinating Center (DCC) led by Professor Kim (DCC PI) in the UW Department of Biostatistics and Medical Informatics provides expertise and support for the INVESTED trial in data management, quality control and quality assurance, information technology for communication and trial conduct monitoring, and statistical methods for design including randomization, interim monitoring, analysis both interim and final, interpretation of findings from analysis, preparation of results in tabular and graphical formats for presentation, and publication of findings from the trial. Professor Kim oversees all DCC activities with specific responsibilities for communication and trial conduct monitoring and statistical methods; UW has partnered with the Frontier Science Foundation (https://www.frontierscience.org) for data management, quality control and quality assurance, and IT support for the INVESTED trial.


The MyHEART Study: A Young Adult Hypertension Self-Management Randomized Controlled Trial (MyHEART) (1 R01 HL132148 05/01/17-04/30/22)

The MyHEART trial will test the effect of the MyHEART (My Hypertension Education and Reaching Target) program, a hypertension self-management intervention consisting of home blood pressure monitoring and health coaching on hypertension control and hypertension self-management behavior as compared to usual clinical care in lowering systolic and diastolic blood pressure and to examine whether MyHEART’s effects are mediated through perceived competence, autonomy, motivation and activation in young adults with uncontrolled hypertension in a randomized, multi-center, controlled trial.

Principal Investigator DCC: Heather Johnson, MD, University of Wisconsin-Madison
Co-Investigator, DCC Director: KyungMann Kim, PhD, University of Wisconsin-Madison
ClinicalTrials.gov Identifier: NCT03158051
Target Enrollment: 310
Study Start Date: February 2018
Estimated Completion Date: April 2022
Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)

The MyHEART Data Coordinating Center (DCC) will be led by Professor Kim. He will provide expertise and support for the MyHEART trial with limited involvement in data management which will be done using REDCap, a research electronic data capture system.


Fecal Microbiota Transplant for C. difficile Infection in Solid Organ Transplant Recipients (FMT) (1 U01 AI125053 09/15/18-08/31/23)

The FMT trial will test a novel intervention, fecal microbiota transplant, for treatment of C. difficile infection (CDI) in solid organ transplant recipients as compared to the standard of care oral vancomycin in reducing recurrence of CDI in a randomized, multi-center, double-blind, double-dummy controlled trial.

Principal Investigator DCC: Nasia Safdar, MD, University of Wisconsin-Madison
Co-Investigator, DCC Director: KyungMann Kim, PhD, University of Wisconsin-Madison
ClinicalTrials.gov Identifier: NCT03617445
Target Enrollment: 158
Study Start Date: February 2019
Estimated Completion Date: December 2023
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

The FMT Data Coordinating Center (DCC) will be led by Professor Kim. He will provide expertise and support for the FMT trial much as in the INVESTED trial in partnership with the Frontier Science Foundation for data management, quality control and quality assurance, and IT support.

Contact Us

KyungMann Kim, PhD
DCC Principal Investigator
kyungmann.kim@wisc.edu
608-265-6380

Kelly Miller, BS, CCRC
DCC Research Administrator
kamiller@biostat.wisc.edu
608-262-8141