Nocturnal Hypertension and Nocturia in African American Men

NCT03048734 | Completed

• 1 other identifier: Pro00046856
• Study Type: observational
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study to obtain pilot data on Nocturnal Hypertension and Nocturia. In Dr. Victor's current NIH grant (Cut Your Pressure Too: The LA Barbershop Blood Pressure Study) the results show that uncontrolled systolic hypertension is independent determinantal of nocturia in African American men. We now went 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 bed time rather than in the morning will: A. Lower the systolic Blood pressure during sleep B. Improve Nocturia and results in better sleep quality. The results suggest that short acting hydrochlorothiazide may contribute to nocturia in some patients.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Number of events of Nocturia in relation to blood pressure.

  will evaluate the patients with how many times they go to the bathroom and assess the relation with their nocturnal blood pressure.

  9 days

Study Arms (2)

Group (1): Men with Nocturia ≥2.

Group (2): Men with no nocturia (0-1).

Eligibility Criteria

• Age: 35 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit men between 35 and 79 years old who are able to give informed consent, and are willing to be contacted for future research. Protocol will be approved by our Institutional Review Board and informed written consent will be obtained from all subjects.

You may qualify if:

• African American Men
• Age 35 to 79 year-old
• Able to give informed consent
• Pass the home sleep study
• Willing to wear the wrist Actigraphy monitor for 9 days continuously.
• Willing to wear ambulatory blood pressure monitoring (ABPM) for 48 hours twice during the 9 days of the study period.

You may not qualify if:

• Diabetes Mellitus
• Taking Prostate medication
• Symptoms of prostate disease or urinary urgency
• Sleep apnea
• A neck circumference greater than 17 inches
• Using Continuous Positive Airway Pressure (CPAP)
• History of a diagnosis of Sleep Apnea
• Apnea Hypopnea Index (AHI) \> 15 per hour

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ronald Victor, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: February 9, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 14, 2020

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share