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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Thiazide Treatment Group: Non-diabetics with sleep systolic blood pressure of 125-139 mm Hg and awake systolic blood pressure \<160 mm Hg Participants will be treated with Indapamide 0.625mg once a day After 4 weeks of treatment, the investigators will monitor chemistries/electrolytes with a fingerstick point of care device and repeat ambulatory blood pressure monitoring the investigators will repeat ambulatory blood pressure monitoring at 4, 8, and 12 weeks after treatment initiation. If sleep systolic blood pressure is \< 120 mm Hg, the investigators will continue treatment
At 4 weeks of therapy, individuals initially assigned to the Thiazide treatment group whose ambulatory blood pressure recheck showed a sleep systolic blood pressure \>120 mm Hg, the investigators will intensify their blood pressure medications by adding on Telmisartan 40 mg and Amlodipine 5 mg. In two week intervals, labs and ambulatory blood pressure will be measured. If the systolic blood pressure \>120, then the doses of Telmisartan and Amlodipine will be up-titrated until the sleep systolic blood pressure is \<120.
Cedars-Sinai Medical Center
Los Angeles, California, United States
Participant Compliance
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
Time frame: 12 weeks
change in the systolic blood pressure in participants
The within subject variation in millimeter of mercury for repeated measures of nocturnal systolic blood pressure by ambulatory blood pressure.
Time frame: Change from Baseline Systolic Blood Pressure at 12 weeks
change nocturnal systolic blood pressure in relation with frequency of nocturia
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 .
Time frame: change from baseline at 12 weeks after treatment initiation.
Night time blood pressure medication dosing in relation with frequency of Nocturia
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 .
Time frame: Change of systolic blood pressure from baseline at 12 weeks.
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Combination Medication Treatment Group: Diabetics or sleep systolic blood pressure of ≥ 140 mm Hg, or awake systolic blood pressure of ≥ 160 mm Hg * Participants will be treated with starting doses of a long acting blood pressure regimen of Telmisartan 40 mg and Amlodipine 5 mg daily * After 2 weeks, the investigators will monitor chemistries/electrolytes with a fingerstick point of care device and repeat ambulatory blood pressure monitoring * If sleep systolic blood pressure is \< 120 mm Hg, the investigators will continue treatment and repeat ambulatory blood pressure again in another 2 weeks to assess reproducibility * If sleep systolic blood pressure is \> 120 mm Hg, the investigators will increase Telmisartan dose to 80 mg and the Amlodipine dose to 10 mg. Ambulatory blood pressure monitoring will be checked again after 2 weeks of therapy to verify efficacy.