Treating Nocturnal Hypertension and Nocturia in African American Men

NCT03319823 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 48809
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

High Blood Pressure

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

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

Drug: Thiazide Treatment Group; Drug: Intensified Thiazide Treatment Group

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.

Drug: Combination Medication Treatment Group

Interventions

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

Thiazide Therapy Group

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.

Thiazide Therapy Group

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 * 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.

Combination Therapy Group

Eligibility Criteria

• Age: 35 Years - 59 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Clinic for Hypertrophic Cardiomyopathy and Aortopathies

Model Details: 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.

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 24, 2017
• Study Start: October 25, 2017
• Primary Completion: February 13, 2019
• Study Completion: February 1, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)