Telemonitoring of Uncontrolled Hypertension

NCT02730052 | Withdrawn DMC

• 1 other identifier: 11/16
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 8

Brief Summary

The proportion of hypertensive patients achieving adequate blood pressure control meeting guideline targets remains low. Of those patients on blood pressure lowering drugs, only 50% reach control. Objectives:

• Screening to check for eligibility.
• Randomisation in a 1:1 proportion to control or experimental arm: In the control arm, doctors will receive reports on the self-measured blood pressure based on diary cards; in the experimental group, doctors will receive weekly reports via telemonitoring.
• Treatment period: Doctors will adjust treatment according to the present guidelines of Hypertension. Blood pressure control is a home blood pressure below 135 mm Hg systolic and 85 mm Hg diastolic. Once blood pressure control is achieved the treatment period ends.
• Late follow-up: Assessment of blood pressure control at home 3 months after completion of the treatment period by means of telemonitoring. Sample size: 120 patients per group. Patients: recruited at clinics from Uruguay and Argentina. Main Inclusion Criteria:
• Women and men, age range 20 to 80 years.
• Uncontrolled hypertension and new diagnosed hypertension with a self-measured blood pressure at home of 135 mm Hg systolic and/or 85 mm Hg diastolic or more;
• Patients should be willing to accept adherence checking during follow-up and sign an informed written consent. Exclusion Criteria
• Patients emotionally or intellectually not capable of measuring their blood pressure at home;
• A clinical or social context, which is suboptimal for the self-measurement of blood pressure;
• Pregnancy;
• Alcohol or substance abuse or psychiatric illnesses;
• Participation in another study. Expected outcomes: blood pressure control will be achieved faster in the telemonitoring group.

Conditions

Hypertension

Keywords

Blood pressure control; Hypertension; Office blood pressure; Self-measured blood pressure,; Telemonitoring

Outcome Measures

Primary Outcomes (1)

• Time to blood pressure control

  Blood pressure control will be defined as a self-measured blood pressure at home below 135 mm Hg systolic and 85 mm Hg diastolic. Blood pressure control is assumed to be present if the aforementioned levels are attained during the preceding week to medical control.

  through study completion, an average of 2 years

Secondary Outcomes (8)

• The proportion of patients reaching blood pressure control on self-measurement at home and office measurement

  through study completion, an average of 2 years

• The proportion of patients reaching and maintaining blood pressure control on self-measurement and office measurement at the late follow-up visit

  through study completion, an average of 2 years

• Total pill load per day

  through study completion, an average of 2 years

• Number of single-pill combinations

  through study completion, an average of 2 years

• Adverse events, recorded by a self-administered questionnaire

  through study completion, an average of 2 years

Study Arms (2)

Omron 9200T without Telemonitoring

ACTIVE COMPARATOR

In the control group doctors will receive information on the self-measured blood pressure as recorded at home via a diary card.

Device: Omron 9200T without Telemonitoring

Omron 9200T plus Telemonitoring

EXPERIMENTAL

In the intervention group, doctors will receive weekly reports via telemonitoring of self-measured blood pressure.

Device: Omron 9200T plus Telemonitoring

Interventions

Omron 9200T plus Telemonitoring DEVICE

Telemonitoring of the self-measured blood pressure at home. After each blood pressure measurement the values are transmitted to and stored into a central station where a condensed weekly report is elaborated and delivered to the doctor (investigator).

Also known as: Telemonitored Self-BP Measurement

Omron 9200T plus Telemonitoring

Omron 9200T without Telemonitoring DEVICE

Self-measured blood pressure at home and register the values in a diary card. Participants will perform 2 consecutive blood pressure measurements twice a day for a 7 day period, previous to the visit to the doctor's (investigator) office.

Also known as: Conventional Self-BP Measurement

Omron 9200T without Telemonitoring

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men are eligible. Women of reproductive age should apply effective contraception.
• Age ranges from 20 years (inclusive) to 80 years.
• At screening, patients should have hypertension, which is uncontrolled on medical treatment. Uncontrolled hypertension is an office blood pressure of 140 mm Hg systolic or 90 mm Hg diastolic or higher AND a self-measured blood pressure at home of 135 mm Hg systolic or 85 mm Hg diastolic or more. Practitioners will receive a weekly report on the self-measured blood pressure at home summarising the results of the run-in period.
• At the screening visit, patients should either be untreated for at least 4 weeks or taking a stable drug regimen for at least 4 weeks. Medical treatment can consist of all major drug classes. This includes diuretics, beta-blockers, alfa-blockers, calcium-channel blockers (CCBs), inhibitors of the renin system (angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II type 1 receptor blockers (ARBs), the direct renin inhibitor aliskiren,18 aldosterone receptor antagonists (ARAs), centrally acting antihypertensive drugs and vasodilators (hydralazine). In line with current recommendations and recent studies, unless contra-indicated or not tolerated, aldosterone antagonists, such as spironolactone 25 to 50 mg per day should have been attempted for at least 4 weeks to improve blood pressure control in treatment-resistant patients. (1) The patients should be intellectually and emotionally capable of measuring their blood pressure at home and accept to keep a diary (control group) or to have a report sent to their doctor (intervention group).
• Patient should provide written informed consent.

You may not qualify if:

• The clinical context is suboptimal for telemonitoring of blood pressure:
• Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening period;
• Type 1 diabetes mellitus requiring multiple adjustments of treatment to maintain control or diabetes mellitus with recent hyperglycaemic or hypoglycaemic coma;
• Renal dysfunction defined as an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m2, using the Modification of Diet in Renal Disease formula;
• Secondary hypertension, in which treatment options other than antihypertensive drug treatment are indicated;
• Sleep apnea syndrome that qualifies for treatment with continuous positive airway pressure (CPAP);
• Atrial fibrillation or arrhythmia making oscillometric blood pressure measurement unreliable;
• The patient is on a waiting list for elective surgery or a cardiovascular intervention;
• Patients with alcohol or substance abuse or psychiatric illnesses.
• The patients should not have any serious medical condition, which in the opinion of the investigator, may adversely interfere with self-measurement of blood pressure at home.
• Patients should not participate in any other trial of an investigational drug or device.

Sponsors & Collaborators

• Universidad de la Republica: lead
• Hospital Italiano de Buenos Aires: collaborator
• KU Leuven: collaborator

Study Sites (8)

Center AR-4

Córdoba, Córdoba Province, Argentina

Location

Center AR-3

Rosario, Santa Fe Province, Argentina

Location

Center AR-1

Buenos Aires, Argentina

Location

Center AR-2

Buenos Aires, Argentina

Location

Center UY-1

Montevideo, 11600, Uruguay

Location

Center UY-2

Montevideo, 11600, Uruguay

Location

Center UY-3

Montevideo, 11600, Uruguay

Location

Center UY-4

Montevideo, 11600, Uruguay

Location

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MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jose G Boggia, MD PhD

  Universidad de la Republica - Uruguay

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: February 28, 2016
• First Posted: April 6, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 1, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

UR (4); AR (4)