Effects of Thrice Weekly versus Home Peritoneal Dialysis on Cardiovascular Functional Capacity (ELDEN-PD) Study

J
John Christenson, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
120 participants needed
1 Location

Brief description of study

What is the purpose of this study?

The purpose of this study is to gather information on cardiovascular changes in conventional hemodialysis, and peritoneal dialysis patients. Research indicates that cardiovascular disease remains the leading cause of death among patients with chronic kidney disease (CKD) and those on dialysis.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Recruitment will target dialysis patients. Personnel from the IUSM Division of Nephrology will review medical charts from nephrology clinics for pre-screening to determine potential eligibility. Subjects will be recruited from our outpatient dialysis clinics or home dialysis clinics of the IU Division of Nephrology in accordance with IU recruitment and local clinic policies. Patients may also be recruited from the DaVita, DCI, or Fresenius clinics affiliated with the IU Division of Nephrology. The potential subjects will be contacted by phone or visited by study staff during their outpatient dialysis session.

Detailed description of study

What will happen during the study?

  • All study procedures will be conducted for the purpose of research. We have established the first nephrology-based CPET lab in the United States located at IU University Hospital (room UH 5555). All CPET tests will be conducted in the CPET lab. Musculoskeletal measures may be collected either in the CPET lab or in the clinical research center which are both located on the 5th floor of IU University Hospital.
  • We will collect the following information which is characterized into four groups as described below. We will collect all data from each group below at each study visits (visits 1 and 2) except for demographic information (collected only at study visit 1). Each study visit will take approximately 4 hours. The order in which data is collected during visits from each group may vary.  
  • Subjects will be required to also participate in the Musculoskeletal Function, Imaging and Tissue Resource Core (FIT) Core study, IRB number 170755085. Separate informed consent will be collected for participation in the (FIT) Core. Data from FIT Core study procedures will be collected and used for purposes of participation in this study. 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Kidney Disease, CKD
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
•    All patients age 18 years or older. 
•    All races and ethnicities. Both genders. 
•    CKD stage 5D patients on thrice weekly hemodialysis or home peritoneal dialysis
•    English speaking patients.

Exclusion Criteria
•    Patients with malignancy requiring chemotherapy or metastatic disease. 
•    Patients with chronic obstructive pulmonary disorder and prescribed supplemental oxygen.
•    Patients unable to exercise due to musculoskeletal issues.
•    Patients likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the patient, research team and Investigator’s knowledge.
•    Patients with active implanted medical devices (e.g. cardiac pacemaker, defibrillators).
•    Pregnancy or breastfeeding. 
•    Weight > 300 pounds.

Updated on 15 May 2025. Study ID: NEPH-IIR-VANTIVE-ELDEN-PD, 24641
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