Treating Nocturnal Hypertension and Nocturia in African American Men
Withdrawn before enrolling · Phase 4
Conditions studied: High Blood Pressure
In brief
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 Angeles Barbershop Blood Pressure Study) the results show that uncontrolled systolic hypertension is an independent determinant of nocturia in African American men. the investigators now want to pursue this correlation by designing a new NIH grant proposal to determine whether replacing short acting with long acting drugs and dosing them at bedtime rather than in the morning will: A. Lower systolic blood pressure during sleep B. Improve nocturia and result in better sleep quality
Key facts
- Study ID
- NCT03319823
- Run by
- Cedars-Sinai Medical Center
- People needed
- 0
- Starts
- 2017-10-25
- Expected to finish
- 2021-02-01
- Last updated by the study team
- 2021-02-04
Who can join
Age: 35 and older, up to 59. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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