Telemonitoring of Uncontrolled Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02730052
• Date of registration: 28/02/2016
• Prospective Registration: Yes
• Primary sponsor: Universidad de la Republica
• Public title: Telemonitoring of Uncontrolled Hypertension ERNESTINA
• Scientific title: Estudio RioplateNsE Sobre Telemonitoreo en hIpertensos No-controlAdos
• Date of first enrolment: December 2016
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02730052
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Argentina, Uruguay

Contacts

• Name: Jose G Boggia, MD PhD
• Affiliation: Universidad de la Republica - Uruguay

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Women and men are eligible. Women of reproductive age should apply effective
contraception.

2. Age ranges from 20 years (inclusive) to 80 years.

3. 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.

4. 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).

5. Patient should provide written informed consent.

Exclusion Criteria:

1. 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.

2. 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.

3. Patients should not participate in any other trial of an investigational drug or
device.



Age minimum: 20 Years
Age maximum: 79 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Device: Omron 9200T without Telemonitoring

Device: Omron 9200T plus Telemonitoring

Primary Outcome(s)

Time to blood pressure control [Time Frame: through study completion, an average of 2 years]

Secondary Outcome(s)

The proportion of patients reaching and maintaining blood pressure control on self-measurement and office measurement at the late follow-up visit [Time Frame: through study completion, an average of 2 years]

Assessment of quality of life using the Euro-Quality-of-life questionnaire "EQ-5D-5L" [Time Frame: through study completion, an average of 2 years]

Assessment of drug adherence using Morisky questionnaire [Time Frame: through study completion, an average of 2 years]

Number of single-pill combinations [Time Frame: through study completion, an average of 2 years]

Adverse events, recorded by a self-administered questionnaire [Time Frame: through study completion, an average of 2 years]

The proportion of patients reaching blood pressure control on self-measurement at home and office measurement [Time Frame: through study completion, an average of 2 years]

Total pill load per day [Time Frame: through study completion, an average of 2 years]

Health care costs from randomization to last follow-up [Time Frame: through study completion, an average of 2 years]

Secondary ID(s)

11/16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

KU Leuven

Hospital Italiano de Buenos Aires