Treating Nocturnal Hypertension and Nocturia in African American Men

NCT ID: NCT03319823

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-25
• Study Completion Date: 2021-02-01

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:

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thiazide Therapy Group

• 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 Type: EXPERIMENTAL

Thiazide Treatment Group

Intervention Type: 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

Intensified Thiazide Treatment Group

Intervention Type: 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.

Combination Therapy Group

• 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.

Group Type: EXPERIMENTAL

Combination Medication Treatment Group

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Florian Rader

Co-Director, Clinic for Hypertrophic Cardiomyopathy and Aortopathies

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

48809

Identifier Type: -

Identifier Source: org_study_id