Clinical trial NCT03319823: Treating Nocturnal Hypertension and Nocturia in African American Men
Official title: A Pilot Study: Treating Nocturnal Hypertension and Nocturia in African American Men
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: High Blood Pressure
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 0
Sex: MALE
Minimum age (years): 35
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study Design and Procedures

Participants who meet the inclusion criteria will be contacted by the study team. The purpose of the study will be explained, and they will be asked to sign an informed consent form. Based on their nocturnal systolic blood pressure, the investigators will assign participants to one of two treatment groups:

* Group (1): Thiazide Therapy Group: Men without diabetes, and mild hypertension - a sleeping systolic blood pressure of 125-139 mm Hg, and an awake average blood pressure of \< 160 mm Hg.
* Group (2): Combination Therapy Group: Men with diabetes, or with more severe hypertension - a sleeping blood pressure of ≥ 140 mm Hg, or an awake average blood pressure of ≥ 160 mm Hg.
Primary purpose: TREATMENT

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 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

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 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.

Eligibility 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

Primary outcomes:
measure: Participant Compliance
timeFrame: 12 weeks
measure: change in the systolic blood pressure in participants
timeFrame: Change from Baseline Systolic Blood Pressure at 12 weeks
measure: change nocturnal systolic blood pressure in relation with frequency of nocturia
timeFrame: change from baseline at 12 weeks after treatment initiation.
measure: Night time blood pressure medication dosing in relation with frequency of Nocturia
timeFrame: Change of systolic blood pressure from baseline at 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
References: