Effects of Thrice Weekly versus Home Hemodialysis on Cardiovascular Functional Capacity (ELDEN-HHD)
Kenneth Lim
Primary Investigator
Brief description of study
What is the purpose of this study?
The purpose of this study is to gather information on cardiovascular changes in hemodialysis patients, both home-hemo and conventional hemo-dialysis. Research indicates that cardiovascular disease remains the leading cause of death among patients with chronic kidney disease (CKD) and those on dialysis.
Detailed description of study
What will happen during the study?
We will conduct a single-center, nonrandomized 2-arm prospective controlled trial. We will recruit a total of approximately n=50 HD patients into two groups, comparing home HD (approximately n=25) versus conventional thrice weekly HD (approximately n=25) at baseline and 12 months (visit 2). The visit window for visit 2 will be between 12 months (- 4 weeks) to 12 months (+ 6 months). Patients in each group will be matched by age (+/- 10 years), gender and dialysis vintage (duration on dialysis; +/- 7 years). All patients will undergo musculoskeletal testing in the FIT core, echocardiography, CPET testing and bioimpedance testing.
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 3 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.
In addition, as some subjects may also be participants in another study under the same PI, with the same measurements, (“Effects of long interdialytic intervals on Cardiovascular Functional Capacity (ECON) Study” IRB study #: 2011886573.”), we will also utilize data from that study as necessary.
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 races and ethnicities. Both genders.
• CKD stage 5D patients on thrice weekly hemodialysis or home hemodialysis (HHD)
• 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.
