Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
NCT07115953
Cardiovascular Diseases, Chronic Disease
Melbourne, Australia
View Trial DetailsNCT Number: NCT04185844
Despite many advances in our understanding of the natural history and progression of chronic kidney disease (CKD) and cardio vascular disease (CVD) in the parent CRIC study over the past 15 years, important questions about key risk factors for these diseases remain unanswered in the AI population. To address this burden of CKD in AI communities Investigators formed a consortium of investigators with extensive experience in conducting research of chronic diseases including diabetes, cardiovascular and kidney disease in AIs of Southwestern US. The proposed CRIC ancillary cohort study of 500 AIs (AI-CRIC) will rapidly improve our understanding of both potential risk factors for CKD progression, as well as the scope of this disease among AIs. This study leverages the current CRIC study and incorporates the planned activities of the next phase of the study - "CRIC 2018" - by implementing contemporary CRIC protocols for kidney and cardiovascular measurement and outcomes.
Interested in participating?
Request Info21 year–80 year
All sexes
Observational
NIDDK-Phoenix Epidemiology and Clinical Research, Phoenix, Arizona, United States
Investigators will conduct a longitudinal study of a CKD cohort of Southwest AIs to identify unique risk factors for CKD and CVD progression and compare CKD and CVD event rates and risk factors between AI and the populations represented in CRIC. Investigators will establish a specimen bank to support future ancillary studies designed to identify and examine biomarkers associated with the progression of CKD in AIs.
At the Clinic Visit the following will occur:
This visit takes about 1 to 2 hours. Participants will be contacted by telephone six months after the Baseline Visit to ask about recent medical events and medications.
Participants will be asked to return to the center for annual visits during which many but not all of the procedures described above will be conducted.
Additionally, participants will be asked to participate in one of two substudies using remote data collection techniques to identify trajectories of kidney function and cardiovascular risk sub-phenotypes
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 5 years
Primary outcomes regarding Cardio vascular disease will focus on clinical events indicative of ischemic heart disease, CHF, stroke, and peripheral vascular disease supplemented by radiographic evidence of progressive CVD.
Time frame: 5 years
The measure is reflected in decline of GFR levels
Time frame: 5 years
The measure is reflected in decline of GFR levels
Time frame: 5 years
The composite clinical outcome includes onset of End Stage Renal Disease, Significant loss of renal function or changes in proteinuria over time from baseline
Time frame: 5 years
The changes in the levels of proteinuria overtime
Contact information is provided by the study sponsor or research team.
University of New Mexico
Other
Acronym: AI-CRIC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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