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Treating Nocturnal Hypertension and Nocturia in African American Men

Primary Purpose

High Blood Pressure

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Thiazide Treatment Group

Intensified Thiazide Treatment Group

Combination Medication Treatment Group

About this trial

This is an interventional treatment trial for High Blood Pressure

Eligibility Criteria

35 Years - 59 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Thiazide Therapy Group

Combination Therapy Group

Arm Description

• 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.

Outcomes

Primary Outcome Measures

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

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 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 .

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 .

Secondary Outcome Measures

Full Information

NCT ID

NCT03319823

First Posted

October 10, 2017

Last Updated

February 2, 2021

Sponsor

Cedars-Sinai Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03319823

Brief Title

Treating Nocturnal Hypertension and Nocturia in African American Men

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Due to the Pandemic, we decided to end this study.

Study Start Date

October 25, 2017 (Actual)

Primary Completion Date

February 13, 2019 (Actual)

Study Completion Date

February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High Blood Pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Thiazide Therapy Group

Arm Type

Experimental

Arm Description

• 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

Arm Title

Combination Therapy Group

Arm Type

Experimental

Arm Description

• 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 Type

Drug

Intervention Name(s)

Thiazide Treatment Group

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Intensified Thiazide Treatment Group

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Combination Medication Treatment Group

Intervention Description

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.

Primary Outcome Measure Information:

Title

Participant Compliance

Description

Time Frame

12 weeks

Title

change in the systolic blood pressure in participants

Description

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

Title

change nocturnal systolic blood pressure in relation with frequency of nocturia

Description

Time Frame

change from baseline at 12 weeks after treatment initiation.

Title

Night time blood pressure medication dosing in relation with frequency of Nocturia

Description

Time Frame

Change of systolic blood pressure from baseline at 12 weeks.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Treating Nocturnal Hypertension and Nocturia in African American Men

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