NCT02623036

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 7, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

2.4 years

First QC Date

November 19, 2015

Last Update Submit

May 23, 2017

Conditions

Hypertension, Resistant to Conventional Therapy

Keywords

chronotherapyangiotensin converting enzyme inhibitorsambulatory blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

  • Change from baseline nighttime blood pressure

    Average blood pressure between 0000-0600.

    Baseline and 4-6 weeks

Secondary Outcomes (2)

  • Change from baseline night to day blood pressure ratio (dipping status)

    Baseline and 4-6 weeks

  • Change from baseline 24 Hour Blood Pressure

    Baseline and 4-6 weeks

Study Arms (2)

Enalapril arm

ACTIVE COMPARATOR

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

Drug: Equivalent dose enalapril

Lisinopril arm

ACTIVE COMPARATOR

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

Drug: Equivalent dose lisinopril

Interventions

Equivalent dose enalaprilDRUG

Chronotherapy with enalapril.

Also known as: Vasotec
Enalapril arm
Equivalent dose lisinoprilDRUG

Chronotherapy with lisinopril

Also known as: Prinivil
Lisinopril arm

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Family Medicine Center

Savannah, Georgia, 31404, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 18574054BACKGROUND

  • 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.

    PMID: 23817082BACKGROUND

  • 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.

    PMID: 1647954RESULT

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy

Interventions

EnalaprilatLisinopril

Intervention Hierarchy (Ancestors)

EnalaprilDipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • John D. Bucheit, Pharm D

    Memorial Health University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John D Bucheit, Pharm.D.

CONTACT

912-350-8404bucheit_jd@mercer.edu

Cindy Gleit, M.D.

CONTACT

912-350-8404cindygleit@memorialhealth.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 19, 2015

First Posted

December 7, 2015

Study Start

November 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

May 25, 2017

Record last verified: 2017-05

Locations

US(1)