An interventional study of Home blood pressure monitoring (telemonitoring) and Standard care in Hypertension, sponsored by Maasstad Hospital. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-13.
Sponsored by Maasstad Hospital · Not applicable, Interventional, and Health services research
Among 152 studies in Hypertension with a site in Netherlands — 23 open to participants now, 32 under way, 7 of them phase 3. Hypertension · Netherlands.
Among the 152 studies in Hypertension with a site in Netherlands, this one is the 44th largest by planned enrollment of the 127 interventional ones, is one of 9 that started in 2023, is one of 44 with no phase, reaches primary completion later than 6 of the 31 other live ones, and was the 128th registered.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 400 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →23 of the 152 studies in Hypertension with a site in Netherlands are open now, in 12 countries. Each count lists the studies.
Of the 564 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (35%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →152 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 9 started in 2023.
Median enrollment 139 across the 127 interventional studies, 626 across the 25 observational. Of the 103 that completed or were terminated, 38 (37%) have results posted.
81 of 152 have an industry lead sponsor. The 10 most frequent:
Maasstad Hospital is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Maasstad Hospital has 1 study filed under Hypertension — fewer than ten, so there is no comparison to draw.
9 of the studies in Hypertension with a site in Netherlands that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03683186Phase 3United TherapeuticsA Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension | 2026-12 |
| NCT03604198Corcept TherapeuticsExtension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome | 2026-12 |
| NCT06059638Orchestra BioMed, IncBradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT | 2026-12 |
| NCT06256991University Medical Center GroningenPotassium Correction for RAAS Optimization in Chronic Kidney Disease | 2026-12 |
| NCT07294794University of BirminghamPersonalised Pharmacometabolomic-guided Strategy Trial to Optimise Treatment for Hypertension | 2026-12-31 |
Among the 152 studies in Hypertension with a site in Netherlands, from their registry updates:
Rationale: Hypertension is the most significant risk factor for cardiovascular disease and can be mitigated by lifestyle and medical management. Telemonitoring as a novel management approach to perform hypertension management at distance has been thriving but became indispensable during the COVID-19 pandemic. However, evidence of an effective implementation for telemonitoring remains to be elucidated.
Hypothesis: Telemonitoring with a smartphone application, which includes mixed automated services for a personal counselling program (PCP), on top of self-monitoring (SM) will lead to improvement of hypertension control rates, medication adherence and lifestyle behaviors and lower health care costs in patients with hypertension when compared to usual care.
Objective: To investigate the effects of PCP+SM on hypertension control rate and lifestyle behaviors as compared with usual care.
Study design: The study is a non-blinded randomized controlled clinical trial in adults with hypertension, in a multicenter hospital setting . We will randomize participants in a 1:1 fashion to the intervention group (PCP+SM), or to the control group (usual care).
Study population: 400 patients, patients, aged ≥18 years with hypertension (RR >140/90) Main study outcome: hypertension control rate (%\<140/90mmHg) after 6 months (as measured by the SPRINT protocol)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Home blood pressure monitoring + E-coaching
Other: Home blood pressure monitoring (telemonitoring)
Standard care in patients with hypertension
Other: Standard care
Using a digital mobile phone based telemonitoring platform to A: monitor patients and adjust their treatment accordingly based on the remote monitoring outcomes and B: provide E-Coaching/self learning modules (lifestyle)
Standard outpatient blood pressure management
Hypertension control rate
Percentage of patients with blood pressure on target (RR\<135/85)
Time frame: 6 months
Blood pressure control
Mean systolic and diastolic blood pressures for both groups
Time frame: 6 weeks, 6 months and 12 months
Medication use
Biochemical assessment of antihypertensive medication concentrations in blood. Number of antihypertensive agents used at 6 months. Number of antihypertensive medication changes at 6 months.
Time frame: 6 weeks, 6 months and 12 months
Self-management
Self-efficacy to monitor blood pressure, effect of coaching on disease insight and skills using PAM 13 and EQ5DL questionnaires
Time frame: baseline and 6 months
Patient and Healthcare provider Satisfaction
Patients and health-care provider satisfaction as measured with TUQ and MAUQ questionnaires. The scales are from 1 to 7 (disagree to agree)
Time frame: 6 months and 12 months
Hospitalizations
Hospitalizations resulting from poor blood pressure control or cardiovascular complications resulting from poor blood pressure control (hypertensive emergencies, MI's, stroke)
Time frame: 6 months and 12 months
Adverse cardiovascular events
Myocardial infarction, cerebrovascular events and hypertensive emergencies.
Time frame: 6 months and 12 months
Hypertension control rate
Percentage of patients with blood pressure on target (RR\<140/90)
Time frame: 6 weeks and 12 months
Direct Medical Costs
* Costs related to HBPT (blood pressure monitor costs) * Costs related to additional prescribing of antihypertensive drugs * Costs related to a physical appointment for patients in a hypertension care pathway * Costs related to reimbursement for patients in a HBPT program * Costs related to hospital admissions resulting primarily from poorly controlled hypertension or hypertensive emergencies. * Costs related to hospital admissions or required care pathways following a cardiovascular complication as a result from poorly controlled hypertension * Future related medical costs
Time frame: 6 weeks, 6 months and 12 months
Direct Non-Medical Costs
* Training costs related to the use of HBPT for both telenurses, nurse specialists and clinicians * Development and exploitation costs (time spent developing the HBPT protocol, license costs for the application) * Salaries for involved health care providers during HBPT
Time frame: 6 weeks, 6 months and 12 months
Indirect Non-Medical costs
* Costs related to work absence (loss of productivity for short-term absence, friction cost for long-term absence) * Costs related to the hospital visit (travel costs, parking costs)
Time frame: 6 weeks, 6 months and 12 months
Indirect medical costs
o Future unrelated medical costs (as calculated using the iMTA PAID module: costs related to other diseases due to improved life expectancy
Time frame: 6 weeks, 6 months and 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Mar 2025, 23 months after the start.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 23 months is close to that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Maasstad Hospital