ROCK-D
K
Kenneth Lim
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
140 participants needed
1 Location
Overview
The purpose of the study is to identify the best diagnostic test that could be used to assess cardiovascular risk in patients on dialysis. The study will also develop a new scoring system that can more accurately calculate the risk of developing an adverse cardiovascular event.
Description
The central hypothesis is that assessment of VO2Peak by CPET will be
superior to other diagnostic tests for predicting future CV events in patients
with advanced CKD on dialysis. We will test this hypothesis by completing the
following aims:
AIM 1 (A) will
determine the predictive value of VO2Peak compared to other
clinically used tests (cardiac CT, T1 MRI, physical function testing) for
predicting CV outcomes at 3-years; and (B) determine if changes in VO2Peak
at 1-year are superior to baseline VO2Peak in predicting CV outcomes
at 3-years.
AIM 2 will develop a new
risk stratification model and assess whether the inclusion of functional
indices can accurately prognosticate future CV outcomes in CKD compared to
traditional risk scores.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
kidney failure, dialysis
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
- · All patients aged 18 years or older.· All races and ethnicities. Both genders.· CKD stage 5D patients on thrice weekly hemodialysis for at least 3 months.· English speaking patients.
Exclusion Criteria:
- · Patients with malignancy requiring chemotherapy or metastatic disease.· 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.· Contraindications to CPET testing as described in our CPET standard operating procedure (SOP)· Weight > 300 pounds.
Updated on
15 May 2024.
Study ID: 15951; NEPH-IIR-ROCK-D
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