HypertensionLAPTOHPNCT01743170
Telemonitoring of Hypertensive Patients
A study testing Telemonitoring of self-measured blood pressure in people with Hypertension, run by KU Leuven at 7 sites in Belgium.
Trial summary
The proportion of hypertensive patients achieving adequate blood pressure control meeting guideline targets remains low. Of hypertensive patients, only 50% are on antihypertensive medications. Of those on blood pressure lowering drugs, only 50% have their blood pressure controlled. The objectives of this study are: 1. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Telemonitoring of self-measured blood pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 7 sitesBelgium
- Study dates
- 1 Jun 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and men are eligible. Women of reproductive age should apply effective contraception.
- Age ranges from 20 years (inclusive) to less than 80 years.
- Patients should have hypertension, which is uncontrolled on medical treatment.
- 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, β-blockers, α-blockers, calcium-channel blockers (CCBs), inhibitors of the rennin system (angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II type-1 receptor blockers (ARBs), the direct renin inhibitor aliskiren, 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.
- 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.
Who cannot join
- 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 hyperglycemic or hypoglycemic 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 (MDRD) 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).
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Belgium7 sites
Center C2
Boutersem, BE-3370
Center C3
Grimde, BE-3300
Center C4
Leuven, BE-3000
Center C6
Leuven, BE-3000
Center C7
Leuven, BE-3000
Center C5
Tienen, BE-3300
Center C1
Wilsele, BE-3012
About this study
Official title: Leuven Academic Programme for Telemonitoring of Hypertensive Patients
The proportion of hypertensive patients achieving adequate blood pressure control meeting guideline targets remains low. Of hypertensive patients, only 50% are on antihypertensive medications. Of those on blood pressure lowering drugs, only 50% have their blood pressure controlled.
The objectives of this study are:
- To test the feasibility of telemonitoring of blood pressure in Flemish general practices.
- To investigate in a randomized fashion whether telemonitoring enabled self-measurement of blood pressure leads to faster blood pressure control than self-measurement without the telemonitoring information.
- The secondary endpoints include various blood pressure indexes, adverse effects, a simple assessment of quality of life, adherence, a log of technical problems, and cost effectiveness (EQ-5D-5L).
Read the detailed description
Hypertension affects an estimated 20% to 30% of the world's adult population. Despite the availability of numerous safe and effective pharmacologic therapies, including single-pill combinations of 2-3 drugs, the percentage of patients achieving adequate blood pressure control meeting guideline targets remains low. The rule of halves still applies. Of hypertensive patients, only 50% are on antihypertensive medications. Of those on blood pressure lowering drugs, only 50% have their blood pressure controlled. Achieving target blood pressure levels in the treatment of hypertension requires that patients take their medications not only properly (adherence), but also continue to do so throughout long-term treatment (persistence). Poor medication-taking behavior is a major problem among patients with hypertension, and is one of the main causes of failure to achieve blood pressure control. Self-measurement of blood pressure at home improves adherence to treatment and the control of blood pressure. One might even hypothesize that telemonitoring of blood pressure, which allows instantaneous feedback between doctor and patient might even be more effective than usual self-measurement in improving adherence and reaching treatment tools.
Previous studies demonstrated the feasibility of telemonitoring of blood pressure. However, several issues remain unaddressed.
- Feasibility of telemonitoring within the Belgian context has never been tested. No attempt has ever been made in Belgium to assess adherence to antihypertensive drugs in primary care.
- Telemonitoring of blood pressure will never make it to the routine clinical practice unless it can be proven that application of the technique results in faster and better blood pressure control compared with usual care including self-measurement of blood pressure at home.
- Secondary endpoints must also include adverse events, a simple assessment of quality of life, adherence, a log of technical problems, and cost-effectiveness.
LAPTOHP is a randomized parallel-group study, which will address the feasibility and potential benefits of telemonitoring of blood pressure at home. Eligible patients will be recruited at seven general practices. LAPTOHP will include three stages
- Screening period followed by stratification and randomization: Screening involves checking inclusion and exclusion criteria, ruling out secondary hypertension remediable by specific treatment, and obtaining informed written consent as outlined in the Helsinki declaration. Eligible patients will be stratified by centre and randomized in a one-to-three proportion to control or intervention. Randomization will be implemented by sequentially numbered sealed envelopes, which contain the group assignment. These envelopes will be available at the practices, so that no contact with the Studies Coordinating Centre (SCC) will be necessary to randomize the patient.
- Randomised period: Investigators will optimize medical treatment by rotating patients through different classes of antihypertensive drugs, combining drug classes according to the current guidelines of the European Societies of Cardiology and Hypertension (ESC/ESH), while achieving the maximal tolerated dose of each drug. In the intervention group, investigators will receive a report on the telemonitoring data at weekly intervals; in the control group doctors will receive information on the self-measured blood pressure as recorded at home in the week preceding the office visit via a diary card. Doctors are free to schedule contacts with their patients and office visits at their own discretion or as indicated by the clinical context. Once blood pressure control is achieved, the blood pressure measuring devices (telemonitoring enabled or not) will be recuperated and will become available for a next patient. In the control group, patients will keep a diary card in the week preceding the office visits. In the control group, doctors will receive a full report on all telemonitoring data at the completion of randomized treatment, after patients have achieved blood pressure control.
- Late follow-up: Three months after achieving blood pressure control, all patients will be telemonitored for 1 week and complete a diary card, preceding an office visit.
- Conditions
- Hypertension
- Being tested
- Telemonitoring of self-measured blood pressure
- Keywords
- Blood pressure control, Hypertension, Office blood pressure, Self-measured blood pressure, Telemonitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring of self-measured blood pressureOther
In the intervention group, doctors receive weekly reports via telemonitoring on the self-measured blood pressure
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | In the control group doctors will receive information on the self-measured blood pressure as recorded at home via a diary card. |
| Intervention group | Experimental | In the intervention group, doctors will receive weekly reports via telemonitoring of self-measured blood pressure. Receives: Other: Telemonitoring of self-measured blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 week preceding the last office visit of the randomized treatment visit.
Measured: During the treatment period, there will be no fixed interval between visits, so that doctors can apply their routine care scheme. Expected average of 3 months.
Secondary outcomes (7)
Proportion of patients reaching blood pressure control on self-measurement at home and office measurement.
Blood pressure control on office measurement is a seated blood pressure below 140 mm Hg systolic and 90 mm Hg.
Measured: During treatment period. No fixed time interval between visits. Expected average of 3 months.
The proportion of patients reaching and maintaining blood pressure control on self-measurement and office measurement at the late follow-up visit.
A self-measured home blood pressure of less than 135 mmHg systolic and less than 85 mmHg diastolic
Measured: Three months after achieving blood pressure control
The intensity of medical treatment.
The number of antihypertensive drug classes
Measured: During treatment period, up to 3 months.
Adverse events
Adverse events will be recorded by a self-administered questionnaire (as in previous studies conducted in general practice in Belgium).
Measured: During treatment period, up to 3 months.
Assessment of drug adherence.
The Morisky questionnaire will be used to assess drug adherence.
Measured: During treatment period, up to 3 months.
Assessment of quality of life
The EQ-D5 questionnaire will be used for the assessment of quality of life.
Measured: During treatment period, up to 3 months.
Analysis of cost-effectiveness
The cost-effectiveness analysis will be conducted from the perspective of the Belgian health care system, including both the direct and indirect costs of the intervention. The costs will be balanced against the use of medical resources, including visits, medications, and use of medical resources.
Measured: After completion of the study (expected average is 3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study start1 Jun 2020 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Recruitment by GPs proved to be impossible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan A. Staessen, KU Leuven
- Investigators
- Jan A Staessen, MD, PhD, Principal investigator, University of Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743170
- Sponsor's protocol ID
- LAPTOHP
- Acronym
- LAPTOHP
- Status last verified
- Mar 2020
- First submitted
- 3 Dec 2012
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leuven Academic Programme for Telemonitoring of Hypertensive Patients
- ClinicalTrials.gov ID
- NCT01743170
- Acronym / sponsor ID
- LAPTOHP / LAPTOHP
- Conditions
- Hypertension
- Keywords
- Blood pressure control, Hypertension, Office blood pressure, Self-measured blood pressure, Telemonitoring
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment by GPs proved to be impossible
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proportion of hypertensive patients achieving adequate blood pressure control meeting guideline targets remains low. Of hypertensive patients, only 50% are on antihypertensive medications. Of those on blood pressure lowering drugs, only 50% have their blood pressure controlled.
The objectives of this study are:
- To test the feasibility of telemonitoring of blood pressure in Flemish general practices.
- To investigate in a randomized fashion whether telemonitoring enabled self-measurement of blood pressure leads to faster blood pressure control than self-measurement without the telemonitoring information.
- The secondary endpoints include various blood pressure indexes, adverse effects, a simple assessment of quality of life, adherence, a log of technical problems, and cost effectiveness (EQ-5D-5L).
Detailed description
Hypertension affects an estimated 20% to 30% of the world's adult population. Despite the availability of numerous safe and effective pharmacologic therapies, including single-pill combinations of 2-3 drugs, the percentage of patients achieving adequate blood pressure control meeting guideline targets remains low. The rule of halves still applies. Of hypertensive patients, only 50% are on antihypertensive medications. Of those on blood pressure lowering drugs, only 50% have their blood pressure controlled. Achieving target blood pressure levels in the treatment of hypertension requires that patients take their medications not only properly (adherence), but also continue to do so throughout long-term treatment (persistence). Poor medication-taking behavior is a major problem among patients with hypertension, and is one of the main causes of failure to achieve blood pressure control. Self-measurement of blood pressure at home improves adherence to treatment and the control of blood pressure. One might even hypothesize that telemonitoring of blood pressure, which allows instantaneous feedback between doctor and patient might even be more effective than usual self-measurement in improving adherence and reaching treatment tools.
Previous studies demonstrated the feasibility of telemonitoring of blood pressure. However, several issues remain unaddressed.
- Feasibility of telemonitoring within the Belgian context has never been tested. No attempt has ever been made in Belgium to assess adherence to antihypertensive drugs in primary care.
- Telemonitoring of blood pressure will never make it to the routine clinical practice unless it can be proven that application of the technique results in faster and better blood pressure control compared with usual care including self-measurement of blood pressure at home.
- Secondary endpoints must also include adverse events, a simple assessment of quality of life, adherence, a log of technical problems, and cost-effectiveness.
LAPTOHP is a randomized parallel-group study, which will address the feasibility and potential benefits of telemonitoring of blood pressure at home. Eligible patients will be recruited at seven general practices. LAPTOHP will include three stages
- Screening period followed by stratification and randomization: Screening involves checking inclusion and exclusion criteria, ruling out secondary hypertension remediable by specific treatment, and obtaining informed written consent as outlined in the Helsinki declaration. Eligible patients will be stratified by centre and randomized in a one-to-three proportion to control or intervention. Randomization will be implemented by sequentially numbered sealed envelopes, which contain the group assignment. These envelopes will be available at the practices, so that no contact with the Studies Coordinating Centre (SCC) will be necessary to randomize the patient.
- Randomised period: Investigators will optimize medical treatment by rotating patients through different classes of antihypertensive drugs, combining drug classes according to the current guidelines of the European Societies of Cardiology and Hypertension (ESC/ESH), while achieving the maximal tolerated dose of each drug. In the intervention group, investigators will receive a report on the telemonitoring data at weekly intervals; in the control group doctors will receive information on the self-measured blood pressure as recorded at home in the week preceding the office visit via a diary card. Doctors are free to schedule contacts with their patients and office visits at their own discretion or as indicated by the clinical context. Once blood pressure control is achieved, the blood pressure measuring devices (telemonitoring enabled or not) will be recuperated and will become available for a next patient. In the control group, patients will keep a diary card in the week preceding the office visits. In the control group, doctors will receive a full report on all telemonitoring data at the completion of randomized treatment, after patients have achieved blood pressure control.
- Late follow-up: Three months after achieving blood pressure control, all patients will be telemonitored for 1 week and complete a diary card, preceding an office visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –In the control group doctors will receive information on the self-measured blood pressure as recorded at home via a diary card. |
| Intervention group | Experimental | Other: Telemonitoring of self-measured blood pressureIn the intervention group, doctors will receive weekly reports via telemonitoring of self-measured blood pressure. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women and men are eligible. Women of reproductive age should apply effective contraception.
- Age ranges from 20 years (inclusive) to less than 80 years.
- Patients should have hypertension, which is uncontrolled on medical treatment.
- 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, β-blockers, α-blockers, calcium-channel blockers (CCBs), inhibitors of the rennin system (angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II type-1 receptor blockers (ARBs), the direct renin inhibitor aliskiren, 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.
Key exclusion criteria (11 listed)
- The clinical context is suboptimal for telemonitoring of blood pressure:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemonitoring of self-measured blood pressureIn the intervention group, doctors receive weekly reports via telemonitoring on the self-measured blood pressure | Other | Intervention group |
Primary outcome
Time to blood pressure control
Time frame: During the treatment period, there will be no fixed interval between visits, so that doctors can apply their routine care scheme. Expected average of 3 months.
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 week preceding the last office visit of the randomized treatment visit.
7 secondary outcomes
Proportion of patients reaching blood pressure control on self-measurement at home and office measurement.
Time frame: During treatment period. No fixed time interval between visits. Expected average of 3 months.
The proportion of patients reaching and maintaining blood pressure control on self-measurement and office measurement at the late follow-up visit.
Time frame: Three months after achieving blood pressure control
The intensity of medical treatment.
Time frame: During treatment period, up to 3 months.
Adverse events
Time frame: During treatment period, up to 3 months.
Assessment of drug adherence.
Time frame: During treatment period, up to 3 months.
Assessment of quality of life
Time frame: During treatment period, up to 3 months.
Analysis of cost-effectiveness
Time frame: After completion of the study (expected average is 3 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan A Staessen, MD, PhD principal investigator
University of Leuven
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring of self-measured blood pressure in people with Hypertension, run by KU Leuven at 7 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to blood pressure control (time frame: During the treatment period, there will be no fixed interval between visits, so that doctors can apply their routine care scheme. Expected average of 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.