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Default BP Medication Intensification

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ClinicalTrials.gov Identifier: NCT01994408
Recruitment Status : Terminated (slow enrollment)
First Posted : November 25, 2013
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Florian Rader, MD, MSc, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE November 12, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date February 1, 2017
Study Start Date  ICMJE November 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
Symptomatic hypotension [ Time Frame: from enrollment to 12 weeks ]
Primary safety outcome is symptomatic hypotension during study participation (12 weeks). Safety monitoring will be achieved with patient-directed iPhone-based BP measuring and transmitting to study staff.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
hypertension control rate [ Time Frame: at 12 weeks ]
The investigators will assess blood pressure throughout the study period (12 weeks) with iPhone based technology. Hypertension control is defined as home blood pressure <135/85 mmHg
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Default BP Medication Intensification
Official Title  ICMJE Automatic Medication Increase Protocol in the Treatment of Elevated Blood Pressure
Brief Summary High blood pressure leads to heart attacks and strokes which can be prevented by blood pressure-lowering medication. However, the current office-based prescription of one pill and one dose at a time is ineffective. the investigators want to pilot-test a more effective patient-centered treatment approach, where patients will receive a prescription with gradual but automatic weekly increases of dose and number of pills. Patients will measure their blood pressure with an iPhone compatible cuff, which transmits readings to the doctor or pharmacist, who will stop escalation when the desired blood pressure level is reached. The investigators hypothesize that the intervention will decrease the time to control blood pressure and increase the overall rate of blood pressure control. Therefore, this new treatment model could prevent heart attacks and strokes, and reduce healthcare costs.
Detailed Description This is a pilot 2A trial of an innovative behavioral economics theory-based antidote for physician inertia in the medical treatment of hypertension (HTN). In the current reactive physician-centered model, blood pressure (BP) is measured and medical decisions are made in the physician office; when deciding whether or not to prescribe new medication for a high office BP reading, the physician's default behavior is inaction. The investigators propose default medication intensification as a new patient-centered/pharmacist-assisted proactive treatment model to eliminate physician inertia. For enrolled patients with office BP>155/95, the physician will prescribe a one-month protocol that automatically escalates drug dose and drug number each week. The pharmacist will fill the prescription in a blister pack to simplify adherence. The patient will measure daily home BP with an iPhone cuff that transmits the data electronically to the pharmacist, who will halt the protocol if goal home BP<135/85 is achieved ahead of schedule. the investigators will pilot test the feasibility and safety of self-monitoring plus the new automatic intensification protocol packaged in blisters. Default medication intensification could revolutionize HTN treatment and reduce healthcare costs.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
default drug escalation
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Hypertension
Intervention  ICMJE Other: default intensification
The investigators will determine which blood pressure medications to use. No specific drug will be tested but rather the automatic intensification of medications is the intervention. Examples of drugs used in this study are calcium channel blockers (e.g., amlodipine 2.5 mg to 10 mg) or ACE-inhibitors (e.g., lisinopril 5 mg to 40 mg) or diuretics (HCTZ 25 mg).
Other Name: weekly increasing blood pressure medications.
Study Arms  ICMJE Experimental: default intensification arm (all)
all subjects will receive blister packs with weekly increasing blood pressure medications. There is no control arm for this study
Intervention: Other: default intensification
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 30, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2013)
20
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 to 55 years old
  • office BP of ≥160 mmHg systolic and ≥100 mmHg diastolic (treated or untreated) AND <180 mmHg systolic.

Exclusion Criteria:

  • chronic kidney disease
  • symptomatic coronary artery disease
  • congestive heart failure
  • more than mild valvular heart disease
  • Diabetes mellitus
  • obstructive left ventricular hypertrophy
  • severe electrolyte abnormalities
  • multiple medication intolerances
  • orthostatic hypotension
  • cognitive impairment and mental disorders affecting ability to self-monitor BP
  • patients who are unwilling to measure and transmit BP readings throughout the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994408
Other Study ID Numbers  ICMJE Pro00030558
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Florian Rader, MD, MSc, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE University of California, Los Angeles
Investigators  ICMJE
Principal Investigator: Florian Rader, MD Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP