Treating Nocturnal Hypertension and Nocturia in African American Men
| Status: | Active, not recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 35 - 59 |
| Updated: | 2/27/2019 |
| Start Date: | October 25, 2017 |
| End Date: | December 1, 2019 |
A Pilot Study: Treating Nocturnal Hypertension and Nocturia in African American Men
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
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
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 participate in a new research
program
2. If participants are willing to comply with the study procedures including wearing an
activity monitor, sleep study device, and ambulatory blood pressure monitor
3. The within subject variation for repeated measures of nocturnal blood pressure by
ambulatory blood pressure and activity monitoring
4. If nocturnal systolic blood pressure is higher in men with self-reported nocturia ≥2
than in men with 0-1 nocturia
5. If use of long-acting antihypertensive medication as well as nighttime dosing of
medication can lower nocturnal systolic blood pressure and reduce nocturia
Purpose:
Obtain key pilot data to show feasibility and document the reproducibility of the proposed
measurements.
Determine:
1. The feasibility of the Southern California Healthy Heart and Blood Pressure registry as
an effective method to recruit African American men to participate in a new research
program
2. If participants are willing to comply with the study procedures including wearing an
activity monitor, sleep study device, and ambulatory blood pressure monitor
3. The within subject variation for repeated measures of nocturnal blood pressure by
ambulatory blood pressure and activity monitoring
4. If nocturnal systolic blood pressure is higher in men with self-reported nocturia ≥2
than in men with 0-1 nocturia
5. If use of long-acting antihypertensive medication as well as nighttime dosing of
medication can lower nocturnal systolic blood pressure and reduce nocturia
Purpose:
Obtain key pilot data to show feasibility and document the reproducibility of the proposed
measurements.
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
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Ronald G Victor, MD
Phone: 310-248-7641
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