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Due to the Pandemic, we decided to end this study.
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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:
Purpose:
Obtain key pilot data to show feasibility and document the reproducibility of the proposed measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thiazide Therapy Group | Experimental | • 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 |
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| Combination Therapy Group | Experimental | • 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thiazide Treatment Group | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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 . | 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 . | Change of systolic blood pressure from baseline at 12 weeks. |
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Inclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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:
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| Intensified Thiazide Treatment Group | Drug | 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. |
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| Combination Medication Treatment Group | Drug | Combination Medication Treatment Group: Diabetics or sleep systolic blood pressure of ≥ 140 mm Hg, or awake systolic blood pressure of ≥ 160 mm Hg
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