Our clinical research program spans the spectrum of clinical trials, patient-oriented observational research to epidemiologic studies. One of the major platform technologies in our clinical research lab focuses on the use of state-of-the-art cardiopulmonary exercise testing (CPET) technology, a robust and powerful technology that can accurately and reproducibly assess cardiovascular functional capacity. We are at the forefront of efforts to introduce CPET technology into the field of nephrology. The potential exists for CPET indices such as VO2Peak to be used as a new endpoint for cardiovascular trials in nephrology which can help overcome current challenges in cardio-renal trials methodologies. The technology has the potential to help move the cardio-renal field forward.
ROCK-D Study
ROCK-D stands for “Redefining Cardiovascular Disease in patients on Dialysis” study. The overall aim of the ROCK-D study is to define the optimal diagnostic test and cardiovascular (CV) functional index for CV risk discrimination and prognostication. This unique prospective study aims to recruit a total of 140 chronic hemodialysis patients. All patients undergo comprehensive assessment including functional (standardized physical function testing, isokinetic dynamometry, cardiopulmonary exercise testing, CPET), advanced cardiac imaging (coronary artery CT and cardiac MRI scanning) and other investigations at baseline. Patients undergo repeat functional testing at 1-year follow-up. CV outcomes will be assessed prospectively at 3-years. ROCK-D is funded by the NIH National Heart, Lung and Blood Institute (NHLBI).
Status: Enrollment ongoing (March 2025).
FIT-INDY Study
FIT-INDY stands for “Cardiorespiratory Fitness in Patients with Chronic Kidney Disease in Indiana” study. The overall aim of the FIT-INDY study is to investigate the relationship between kidney function and cardiovascular functional capacity in patients referred for CPET in the State of Indiana. The study aims to create a novel digital platform that will enable efficient, automated capturing and processing of CPET data in the IU Health-IU infrastructure. This is accomplished by creating a streamlined approach across the continuum of translation from capture of raw CPET master storage data and processing of “big data”, to reconciling issues with health exchange information between IU Health and IU. The creation of the FIT-INDY database falls under the field of “translational science”. FIT-INDY is funded through an Indiana CTSI Clinical Translational Science award that is part of an NIH National Center for Advancing Translational Sciences (NCATS) program. To-date, we have enrolled n=1,126 patients.
Status: Enrollment ongoing (March 2025).
ECON Trial
ECON stands for “Effects of Long Interdialytic Intervals on Cardiovascular Functional Capacity” study. The overall aim of the ECON study is to determine how cardiovascular functional capacity (as assessed by VO2Peak) alters during the 3-day vs 2-day interdialytic period and the physiological mechanisms involved. This exploratory proof-of-concept trial will define ventilatory exercise derived response variables across the short- and long- interdialytic periods.
Status: Enrollment complete.
SPARK Trial
SPARK stands for “Comparison of the Self-Paced versus Ramp Incremental Exercise Protocols on Patients with Kidney Failure” study. The overall aim of the SPARK study is to determine the most accurate method for obtaining VO2Peak in individuals on in-center hemodialysis. The trial compares the standard incremental ramp protocol with two novel CPET protocols (self-paced and RISE). SPARK is funded by the Indiana Center for Musculoskeletal Health (ICMH).
Status: Enrollment complete (February 2025).
ELDEN-PD Trial
ELDEN-PD stands of “Effects of Thrice Weekly Hemodialysis versus Peritoneal Dialysis on Cardiovascular Functional Capacity” study. The overall aim the ELDEN-PD study is determine the effects of peritoneal dialysis (PD) compared to conventional hemodialysis (ConHD) on CV functional capacity and the physiological mechanisms involved. The study is currently in the feasibility and pilot phase and funded through an IU Health Values Fund and an investigator-initiated Baxter (Vantive US Healthcare) award.
Status: Enrollment ongoing (March 2025).
ELDEN-HHD Trial
ELDEN-HHD stands of “Effects of Thrice Weekly Home Hemodialysis versus Home Hemodialysis on Cardiovascular Functional Capacity” study. This overall aim of this study is to determine the effects of home hemodialysis (HHD) compared to conventional hemodialysis (ConHD) on CV functional capacity and the physiological mechanisms involved. ELDEN-HHD is the “sister” trial to the ELDEN-PD trial. The study is currently in the feasibility and pilot phase and funded through an IU Health Values Fund and an investigator-initiated Baxter (Vantive US Healthcare) award.
Status: Enrollment ongoing (January 2025).
EMPA-FUNCTION Dialysis Feasibility Trial
EMPA-FUNCTION stands for “Empagliflozin and physical function in patients on dialysis” trial. The overall aim of the EMPA-FUNCTION trial is to determine the role of SGLT2 inhibitors in preventing pathological impaired cardiovascular functional capacity and physical function in patients on dialysis. All patients undergo comprehensive CPET and physical function testing, in addition to skeletal muscle biopsy. The trial is currently in the feasibility phase and is funded by the Indiana CTSI and Indiana Center for Musculoskeletal Health.
Status: Enrollment ongoing (January 2025).
CAPER Study
CAPER stands for Cardiopulmonary Exercise Testing in Renal Failure and After Kidney Transplantation, a prospective landmark study that recruited 253 patients (advanced CKD patients on the kidney transplant waitlist and hypertensive controls). All patients underwent CPET, applanation tonometry and echocardiography before and after kidney transplantation. The study was the first to provide a comprehensive integrated time-course assessment of critical prognostic variables of both functional and structural indices. CAPER was led in collaboration with Dr. Thomas Hiemstra (Cambridge Unviersity) and Dr. Daniel Zehnder (North Cumbria University Hospitals NHS Trust) in the UK.
Status: Study complete.
FHS and MGH-ExS CPET Study
The FHS CPET study was a joint collaborative research study spearheaded by our group that analyzed 3,075 patients from the NIH funded Framingham Heart Study (FHS) and 451 patients from the Massachusetts General Hospital Exercise cohort (MGH-ExS) in collaboration with Dr. Greg Lewis (MGH). This was the largest CPET study in nephrology to-date. Patients in the MGH-ExS cohort also underwent invasive CPET involving right heart catheterization for direct cardiac output measurement.
Status: Study complete.
DESSERT Registry
DESSERT stands for “Division of Nephrology Research Registry.” The overall aim of this study is to create a research registry of patients on dialysis that will serve as a screening database to support multiple clinical studies. An emphasis of DESSERT is to also capture functional data enabling more efficient assessment for exercise testing. DESSERT aims to capture data from the over 900 chronic dialysis patients seen in the Division of Nephrology at Indiana University School of Medicine each year.
Status: Enrollment ongoing (January 2025).