REFOCUS-HTN US-WEST: A Data Infrastructure to Characterize Individuals With Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKaiser Permanente
About this trial
The goal of the REFOCUS-HTN US-WEST program is to gain a better understanding of the role of a hormone called aldosterone in the development of hypertension. The SCALED sub-study is an observational cohort study that will enroll from REFOCUS-HTN cohort for prospective data collection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥1 outpatient, non-emergency department diagnosis of hypertension;
≥2 consecutive outpatient measures of systolic blood pressure ≥130 mmHg at least 90 days apart;
≥2 consecutive outpatient measures of diastolic blood pressure ≥80 mmHg at least 90 days apart.
Hypertension diagnosis within the past 18 months prior to screening.
Disqualifiers
Diagnosed cause of secondary hypertension from drug or alcohol induced, or renovascular hypertension;
Bariatric surgery or GLP1 prescription in the last 12 months;
Exposure to an aldosterone synthase inhibitor or a mineralocorticoid receptor antagonist in the last 12 weeks;
Last known estimated glomerular filtration rate < 45 mL/min/1.73m2 (according to the CKD-EPI equation) at the time of screening;
Trial population
REFOCUS-HTN and SCALED will be conducted at KPNC. The KPNC Division of Research (DOR) will serve as the clinical and data coordinating center for all REFOCUS-HTN activities.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
observational study
Other interventionParticipants are not assigned an intervention
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: SCALED Cohort1 intervention
Trial outcomes
Primary outcomes
1
Aldosterone Trajectories and Aldosterone Dysregulation
Describe aldosterone trajectories and aldosterone dysregulation (including its prevalence) from baseline to six months; describe changes in aldosterone levels over time in the context of measures that are known to be related (e.g. renin, potassium etc.) and/or commonly assessed in routine clinical practice (e.g. blood pressure etc.).
Time frame
From enrollment to the end of the last lab visit six months post initial visitSecondary outcomes
1
Clinical and Demographic Characteristics by Aldosterone Dysregulation Status
Describe the clinical and demographic characteristics of individuals with hypertension, stratified by the presence or absence of aldosterone dysregulation. Outcome measures include baseline demographic characteristics, laboratory measurements, laboratory testing patterns, comorbidities, and medication use.
Time frame
From enrollment to the end of the last lab visit six months post initial visitOther outcomes
1
Proportion of Patients with Aldosterone Dysregulation by Patient Characteristics
Identify patient and clinical characteristics associated with aldosterone dysregulation among individuals with hypertension. The outcome measure will be the proportion of patients with aldosterone dysregulation (overt or subclinical), defined according to the criteria established for the primary objective of the SCALED study. The proportion of patients with aldosterone dysregulation will be evaluated according to demographic characteristics, clinical history, laboratory values, and medication use. Note: These analyses are contingent upon the results of a feasibility assessment based on data available from the SCALED study.
Time frame
From enrollment to the end of the last lab visit six months post initial visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kaiser Permanente
Lead sponsor
AstraZeneca
Collaborator
Source ClinicalTrials.gov