NCT01994408

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.

Trial Health

57
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Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_1 hypertension

Timeline
Completed

Started Nov 2013

Longer than P75 for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
terminated

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, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

November 12, 2013

Last Update Submit

January 30, 2017

Conditions

Hypertension

Keywords

physician inertiahypertensiontelemedicinemobile technology

Outcome Measures

Primary Outcomes (1)

  • Symptomatic hypotension

    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.

    from enrollment to 12 weeks

Secondary Outcomes (1)

  • hypertension control rate

    at 12 weeks

Study Arms (1)

default intensification arm (all)

EXPERIMENTAL

all subjects will receive blister packs with weekly increasing blood pressure medications. There is no control arm for this study

Other: default intensification

Interventions

default intensificationOTHER

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).

Also known as: weekly increasing blood pressure medications.
default intensification arm (all)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (4)

  • Phillips LS, Branch WT, Cook CB, Doyle JP, El-Kebbi IM, Gallina DL, Miller CD, Ziemer DC, Barnes CS. Clinical inertia. Ann Intern Med. 2001 Nov 6;135(9):825-34. doi: 10.7326/0003-4819-135-9-200111060-00012.

    PMID: 11694107BACKGROUND

  • O'Connor PJ. Overcome clinical inertia to control systolic blood pressure. Arch Intern Med. 2003 Dec 8-22;163(22):2677-8. doi: 10.1001/archinte.163.22.2677. No abstract available.

    PMID: 14662620BACKGROUND

  • Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell D, Tyll L, Larson EB, Thompson RS. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008 Jun 25;299(24):2857-67. doi: 10.1001/jama.299.24.2857.

    PMID: 18577730BACKGROUND

  • Bray EP, Holder R, Mant J, McManus RJ. Does self-monitoring reduce blood pressure? Meta-analysis with meta-regression of randomized controlled trials. Ann Med. 2010 Jul;42(5):371-86. doi: 10.3109/07853890.2010.489567.

    PMID: 20504241BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Florian Rader, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: default drug escalation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 12, 2013

First Posted

November 25, 2013

Study Start

November 1, 2013

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

US(1)