A Pilot Study: Treating Nocturnal Hypertension and Nocturia in African American Men
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Cedars-Sinai Medical Center
- Locations
- 1
- Primary Endpoint
- change nocturnal systolic blood pressure in relation with frequency of nocturia
Study Overview
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:
- 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
- If participants are willing to comply with the study procedures including wearing an activity monitor, sleep study device, and ambulatory blood pressure monitor
- The within subject variation for repeated measures of nocturnal blood pressure by ambulatory blood pressure and activity monitoring
- If nocturnal systolic blood pressure is higher in men with self-reported nocturia ≥2 than in men with 0-1 nocturia
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 59 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Thiazide Therapy Group
• 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
Intervention: Thiazide Treatment Group (Drug)
Thiazide Therapy Group
• 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
Intervention: Intensified Thiazide Treatment Group (Drug)
Combination Therapy Group
• 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.
Intervention: Combination Medication Treatment Group (Drug)
Outcomes
Primary Outcomes
change nocturnal systolic blood pressure in relation with frequency of nocturia
Time Frame: change from baseline at 12 weeks after treatment initiation.
measurement of nocturnal systolic blood pressure will occur with continuous ambulatory blood pressure monitors. nocturia frequency will be self reported by participant and then verified by activity monitor (actigraph) built in the ambulatory blood pressure monitor .
Night time blood pressure medication dosing in relation with frequency of Nocturia
Time Frame: Change of systolic blood pressure from baseline at 12 weeks.
the use of long-acting antihypertensive medication as well as nighttime dosing of medication can lower nocturnal systolic blood pressure and reduce the frequency of nocturia which will be self reported by participant and then verified by activity monitor (actigraph) built in the ambulatory blood pressure monitor .
change in the systolic blood pressure in participants
Time Frame: Change from Baseline Systolic Blood Pressure at 12 weeks
The within subject variation in millimeter of mercury for repeated measures of nocturnal systolic blood pressure by ambulatory blood pressure.
Participant Compliance
Time Frame: 12 weeks
If participants are willing to comply with the study procedures including wearing an activity monitor (it is built in the ambulatory blood pressure monitor), sleep study device, and ambulatory blood pressure monitor
Secondary Outcomes
No secondary outcomes reported
Investigators
Florian Rader
Co-Director, Clinic for Hypertrophic Cardiomyopathy and Aortopathies
Cedars-Sinai Medical Center