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Bedtime Administration of Amlodipine Versus Lisinopril (BAVLART)

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Amlodipine
Sponsored by
Allina Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring managed with bedtime administration of lisinopril versus amlodipine

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 40 to 80
  • Newly diagnosed hypertension based on 24 hour ambulatory blood pressure monitor criteria.
  • Minimum Asleep SBP mean of ≥ 120mmHg for inclusion.

Exclusion Criteria:

  • Current antihypertensive medication use
  • Baseline GFR < 45
  • Preexisting macroproteinuria
  • Chronic congestive heart failure
  • History of CVA
  • Diabetes Mellitus
  • Pregnancy
  • Night-shift work
  • Other preexisting contraindication to amlodipine or lisinopril

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Lisinopril

    Amlodipine

    Arm Description

    bedtime administration of lisinopril 20mg

    Bedtime administration of amlodipine 5mg

    Outcomes

    Primary Outcome Measures

    Change in mean sleep-time systolic blood pressure after addition of a bedtime dose of amlodipine versus lisinopril

    Secondary Outcome Measures

    Changes in mean sleep-time diastolic, awake systolic and diastolic blood pressures, including comparison of % achieving target BP
    Impact of individual medications on sleep-time blood pressure drop (dipping status)
    Association of baseline renin levels to sleep-time blood pressure drop
    Association of baseline renin levels with response to amlodipine versus lisinopril
    Association of baseline dipping status with response to amlodipine versus lisinopril
    Association of age and response to amlodipine versus lisinopril

    Full Information

    First Posted
    February 21, 2013
    Last Updated
    April 18, 2013
    Sponsor
    Allina Health System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01835418
    Brief Title
    Bedtime Administration of Amlodipine Versus Lisinopril
    Acronym
    BAVLART
    Official Title
    Bedtime Administration of Amlodipine Versus Lisinopril: a Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    July 2014 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Allina Health System

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study seeks to compare the differences in effectiveness among individual patients treated at for hypertension with bedtime administration of amlodipine versus lisinopril. There will be an analysis of whether one medication was more effective than another and whether specific patient factors could predict who responded better to which one.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension
    Keywords
    managed with bedtime administration of lisinopril versus amlodipine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Lisinopril
    Arm Type
    Experimental
    Arm Description
    bedtime administration of lisinopril 20mg
    Arm Title
    Amlodipine
    Arm Type
    Experimental
    Arm Description
    Bedtime administration of amlodipine 5mg
    Intervention Type
    Drug
    Intervention Name(s)
    Amlodipine
    Intervention Description
    crossover comparison of amlodipine vs lisinopril
    Primary Outcome Measure Information:
    Title
    Change in mean sleep-time systolic blood pressure after addition of a bedtime dose of amlodipine versus lisinopril
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Changes in mean sleep-time diastolic, awake systolic and diastolic blood pressures, including comparison of % achieving target BP
    Time Frame
    1 year
    Title
    Impact of individual medications on sleep-time blood pressure drop (dipping status)
    Time Frame
    1 year
    Title
    Association of baseline renin levels to sleep-time blood pressure drop
    Time Frame
    1 year
    Title
    Association of baseline renin levels with response to amlodipine versus lisinopril
    Time Frame
    1 year
    Title
    Association of baseline dipping status with response to amlodipine versus lisinopril
    Time Frame
    1 year
    Title
    Association of age and response to amlodipine versus lisinopril
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 40 to 80 Newly diagnosed hypertension based on 24 hour ambulatory blood pressure monitor criteria. Minimum Asleep SBP mean of ≥ 120mmHg for inclusion. Exclusion Criteria: Current antihypertensive medication use Baseline GFR < 45 Preexisting macroproteinuria Chronic congestive heart failure History of CVA Diabetes Mellitus Pregnancy Night-shift work Other preexisting contraindication to amlodipine or lisinopril

    12. IPD Sharing Statement

    Learn more about this trial

    Bedtime Administration of Amlodipine Versus Lisinopril

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