The Use of Ambulatory Blood Pressure Monitors to Assess Angiotensin Converting Enzyme Inhibitors

NCT ID: NCT02623036

Last Updated: 2017-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-04-30

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.

Detailed Description

Resistant hypertension is defined as blood pressure > 140/90 mm Hg while adherent to three or more antihypertensive medications or < 140/90 mm Hg treated with four or more antihypertensives. Patients with resistant hypertension may be at risk for elevated nighttime blood pressure >120/70 mm Hg and "non-dipping" (night/day blood pressure > 0.9). A higher rate of cardiovascular events occur during the "morning surge" partially attributed elevated nighttime blood pressure due to increased renin angiotensin aldosterone system (RAAS) activity. Angiotensin converting enzyme inhibitors (ACEIs) suppress RAAS activity

This prospective randomized parallel-group pilot study will occur at Memorial Family Medicine. Eligible patients will undergo three study visits over a 5-8 week span. After providing written informed consent, patients will complete an initial screening visit assessing 25 hour blood pressure using ambulatory blood pressure monitors. Patients will continue the study if they are found to have a nighttime blood pressure >120/70 mm Hg. Patients continuing the study will be randomly assigned to equivalent dose lisinopril or enalapril treatment arms and their administration time will be changed to "bedtime." At the final visit, patients will complete a final ambulatory blood pressure analysis to reassess nighttime blood pressure and dipping status.

It's expected that patients with enalapril treatment will have superior nighttime blood pressure reduction compared to the lisinopril treatment group. If the expected outcome occurs, more patients in the enalapril group will meet their nighttime blood pressure goal (<120/70 mm Hg) and exhibit a "dipping pattern." Current evidence suggests that patients with normal nighttime blood pressure and dipping pattern are at a lower risk for cardiovascular morbidity and mortality.

Conditions

Hypertension, Resistant to Conventional Therapy

Study Design

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

Study Groups

Enalapril arm

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

Group Type: ACTIVE_COMPARATOR

Equivalent dose enalapril

Intervention Type: DRUG

Chronotherapy with enalapril.

Lisinopril arm

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

Group Type: ACTIVE_COMPARATOR

Equivalent dose lisinopril

Intervention Type: DRUG

Chronotherapy with lisinopril

Interventions

Equivalent dose enalapril

Chronotherapy with enalapril.

Intervention Type: DRUG

Equivalent dose lisinopril

Chronotherapy with lisinopril

Intervention Type: DRUG

Other Intervention Names

Vasotec; Prinivil

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Memorial Health University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

John Bucheit, Pharm.D.,BCACP, CDE

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John D. Bucheit, Pharm D

Role: PRINCIPAL_INVESTIGATOR

Memorial Health University Medical Center

Locations

Memorial Family Medicine Center

Savannah, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

John D Bucheit, Pharm.D.

Role: CONTACT

bucheit_jd@mercer.edu

912-350-8404

Cindy Gleit, M.D.

Role: CONTACT

cindygleit@memorialhealth.com

912-350-8404

Facility Contacts

John Bucheit, Pharm.D.

Role: primary

bucheit_jd@mercer.edu

312-350-8404

References

Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, White A, Cushman WC, White W, Sica D, Ferdinand K, Giles TD, Falkner B, Carey RM; American Heart Association Professional Education Committee. Resistant hypertension: diagnosis, evaluation, and treatment: a scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Circulation. 2008 Jun 24;117(25):e510-26. doi: 10.1161/CIRCULATIONAHA.108.189141.

Reference Type: BACKGROUND

PMID: 18574054 (View on PubMed)

Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.

Reference Type: BACKGROUND

PMID: 23817082 (View on PubMed)

Weisser K, Schloos J, Lehmann K, Dusing R, Vetter H, Mutschler E. Pharmacokinetics and converting enzyme inhibition after morning and evening administration of oral enalapril to healthy subjects. Eur J Clin Pharmacol. 1991;40(1):95-9. doi: 10.1007/BF00315146.

Reference Type: RESULT

PMID: 1647954 (View on PubMed)

Other Identifiers

MHUMC 2015.10.01

Identifier Type: -

Identifier Source: org_study_id