HypertensionNCT03048734
Nocturnal Hypertension and Nocturia in African American Men
An observational study of Hypertension, run by Cedars-Sinai Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 79 years, men only
- Conditions the study is for
- Hypertension
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: A Pilot Study : Nocturnal Hypertension and Nocturia in African American Men
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:
- 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.
Read the detailed description
AIMS AND SIGNIFICANCE OF PILOT DATA
Determine:
- The feasibility of Southern California registry as an effective measure to recruit African American men to participate in a new research program.
- If men will comply with the study procedures including Actigraphy and ambulatory blood pressure monitors.
- The within subject coefficient of variation for repeated measures of nocturnal blood pressure by ambulatory blood pressure monitoring, vertical activity at night by Actigraphy monitors.
- Whether the ambulatory Blood pressure itself affects the sleep pattern on Actigraphy.
- Nocturnal systolic blood pressure and nocturnal vertical activity are higher in men with self-reported nocturia ≥2 at night than in men with no reported nocturia.
Purpose:
Obtain key pilot data to show feasibility and document the reproducibility of the proposed measurements.
- Conditions
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group (1): Men with Nocturia ≥2. | Not described | |
| Group (2): Men with no nocturia (0-1). | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald Victor, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048734
- Sponsor's protocol ID
- Pro00046856
- Status last verified
- Oct 2017
- First submitted
- 16 Dec 2016
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study : Nocturnal Hypertension and Nocturia in African American Men
- ClinicalTrials.gov ID
- NCT03048734
- Acronym / sponsor ID
- Pro00046856
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Detailed description
AIMS AND SIGNIFICANCE OF PILOT DATA
Determine:
- The feasibility of Southern California registry as an effective measure to recruit African American men to participate in a new research program.
- If men will comply with the study procedures including Actigraphy and ambulatory blood pressure monitors.
- The within subject coefficient of variation for repeated measures of nocturnal blood pressure by ambulatory blood pressure monitoring, vertical activity at night by Actigraphy monitors.
- Whether the ambulatory Blood pressure itself affects the sleep pattern on Actigraphy.
- Nocturnal systolic blood pressure and nocturnal vertical activity are higher in men with self-reported nocturia ≥2 at night than in men with no reported nocturia.
Purpose:
Obtain key pilot data to show feasibility and document the reproducibility of the proposed measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (1): Men with Nocturia ≥2. | – | – |
| Group (2): Men with no nocturia (0-1). | – | – |
Who may qualify
- Ages
- 35 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Diabetes Mellitus
- Taking Prostate medication
- Symptoms of prostate disease or urinary urgency
- Sleep apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of events of Nocturia in relation to blood pressure.
Time frame: 9 days
will evaluate the patients with how many times they go to the bathroom and assess the relation with their nocturnal blood pressure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Victor, MD principal investigator
Cedars-Sinai Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Cedars-Sinai Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of events of Nocturia in relation to blood pressure. (time frame: 9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.