NCT03319823

Treating Nocturnal Hypertension and Nocturia in African American Men

A Pilot Study: Treating Nocturnal Hypertension and Nocturia in African American Men

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: Male
• Age: 35 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High Blood Pressure

Interventions

Type	Name	Description
DRUG	Thiazide Treatment Group	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
DRUG	Intensified Thiazide Treatment Group	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.
DRUG	Combination Medication Treatment Group	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.

Timeline

• Start date: 2017-10-25
• Primary completion: 2019-02-13
• Completion: 2021-02-01
• First posted: 2017-10-24
• Last updated: 2021-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study