Hypertrophic Cardiomyopathy Clinical Trial

Treating Nocturnal Hypertension and Nocturia in African American Men

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

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 4

Study ID:

NCT03319823

Recruitment Status:

Withdrawn

Sponsor:

Cedars-Sinai Medical Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Cedars-Sinai Medical Center
Los Angeles California, 90048, United States

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 4

Study ID:

NCT03319823

Recruitment Status:

Withdrawn

Sponsor:


Cedars-Sinai Medical Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider