Status:
WITHDRAWN
Treating Nocturnal Hypertension and Nocturia in African American Men
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
High Blood Pressure
Eligibility:
MALE
35-59 years
Phase:
PHASE4
Brief Summary
This is a protocol to obtain pilot data to submit a new NIH grant on Nocturnal Hypertension and Nocturia. In the diversity supplement to Dr. Victor's current NIH grant (Cut Your Pressure Too: The Los ...
Detailed Description
Aims and Significance of pilot data Determine: 1. The feasibility of the Southern California Healthy Heart and Blood Pressure registry as an effective method to recruit African American men to parti...
Eligibility Criteria
Inclusion
- African American Men
- Age 35 to 59 years-old
- Able to give informed consent
- Willing to wear the activity monitor, ambulatory blood pressure monitoring (ABPM), and sleep study device
- Uncontrolled hypertension: both a sleeping average systolic blood pressure of ≥ 125 mm Hg and an awake average systolic blood pressure of ≥ 135 mm Hg
Exclusion
- Severe Sleep Apnea (Apnea Hypopnea Index (AHI) of \> 30 on home sleep study) or history of sleep apnea diagnosis and use of Continuous Positive Airway Pressure therapy
- Uncontrolled Diabetes Mellitus (a random glucose of ≥ 200 mg/dL)
- History of diagnosis or symptoms of either prostate disease or overactive bladder (urinary urgency or frequency during the daytime)
- Chronic kidney disease (Glomerular filtration rate of \< 60 mL/min/1.73 m2 based on the MDRD equation)
- Renal transplant recipient
- Loop diuretic use
- Night shift work
- On chemotherapy for cancer
- Orthostatic hypotension
- o After 2 minutes of standing: a drop in blood pressure of \> 20/10 mm Hg, a standing systolic blood pressure of \< 100 mm Hg, or tachycardia with an increased heart rate of \> 20 beats/minute
- Other reasons deemed unsafe for study participation by Principle Investigator
Key Trial Info
Start Date :
October 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03319823
Start Date
October 25 2017
End Date
February 1 2021
Last Update
February 4 2021
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048