Recruiting
Phase 1

Ambulatory Blood Pressure Monitors

Sponsor:

Memorial Health University Medical Center

Code:

NCT02623036

Conditions

Hypertension, Resistant to Conventional Therapy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Equivalent dose enalapril

Equivalent dose lisinopril

Study Details

Brief summary:

The purpose of this study is to use ambulatory blood pressure monitors to investigate whether enalapril is superior to lisinopril in managing nocturnal hypertension in patients with resistant hypertension currently treated with daytime angiotensin converting enzyme inhibitors.

Conditions

Hypertension, Resistant to Conventional Therapy

Study ID

NCT02623036

Start date

Nov, 2015

Status verified date

May, 2017

Completion date

Apr, 2018

Anticipated

Primary completion date

Apr, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients with clinic blood pressure > 140/90 mm Hg on 3 antihypertensives or clinic blood pressure < 140/90 mm Hg on 4 antihypertensives
  • Currently treated with an angiotensin converting enzyme inhibitor

Exclusion Criteria:

  • Chronic kidney disease (CKD) stage 4 or worse
  • Pheochromocytoma
  • Unstable cardiovascular disease Stroke, Transient Ischemic Attack, Unstable Angina, or Myocardial infarction in the last 30 days
  • Hyperaldosteronism
  • Current pregnancy
  • Shift worker at night
  • Presenting blood pressure > 180/110 mm Hg

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Enalapril arm

Patients randomized to this group will receive equivalent dose enalapril to their current ACEI therapy and change the administration time to bedtime.

active comparator: Lisinopril arm

Patients randomized to this group will receive equivalent dose lisinopril to their current ACEI therapy and change the administration time to bedtime.

Interventions

Equivalent dose enalapril

Chronotherapy with enalapril.

Equivalent dose lisinopril

Chronotherapy with lisinopril

Primary outcome measure

  • Change from baseline nighttime blood pressure [ Time Frame: Baseline and 4-6 weeks ]

Central Contacts and Locations

Central contacts

John D Bucheit, Pharm.D.

912-350-8404bucheit_jd@mercer.edu

Cindy Gleit, M.D.

912-350-8404cindygleit@memorialhealth.com

Locations

Memorial Family Medicine Center

Recruiting

Savannah, Georgia, United States, 31404

Contacts

John Bucheit, Pharm.D.

312-350-8404bucheit_jd@mercer.edu

Principal Investigator:

John Bucheit, Pharm.D.

More Information

Sponsor

Memorial Health University Medical Center

Last update posted

May 25, 2017

Last verified

May, 2017

Keywords

  • chronotherapy
  • angiotensin converting enzyme inhibitors
  • ambulatory blood pressure monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Memorial Health University Medical Center on 2017-05-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.