Overview

Treating Nocturnal Hypertension and Nocturia in African American Men

Status:
Withdrawn
Trial end date:
2021-02-01
Target enrollment:
0
Participant gender:
Male
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 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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cedars-Sinai Medical Center
Treatments:
Sodium Chloride Symporter Inhibitors
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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