|- candidate number||28380|
|- NTR Number||NTR6914|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-dec-2017|
|- Secondary IDs||NL63126.078.17 |
|- Public Title||Resistente HYpertensie: MEten voor Resultaat op Controle Tensie|
|- Scientific Title||Resistant HYpertension: MEasure to Reach Targets|
|- hypothesis||Measuring drug levels combined with personalized feedback leads to a decrease in resistant hypertension after 12 months of follow-up due to improved adherence. |
|- Healt Condition(s) or Problem(s) studied||Therapy resistance hypertension|
|- Inclusion criteria||- Resistant hypertension: office blood pressure > 140/90 mmHg and 24h ABPM (ambulatory blood pressure measurement) daytime blood pressure > 135/85 mmHg despite a medication regimen of antihypertensive drugs from at least three classes including a diuretic.|
- Use of at least two drugs for which DBS-analysis is available (enalapril, perindopril, losartan, valsartan, hydrochlorothiazide, spironolactone, amlodipine and nifedipine.
- Age 18 years and older
- Providing informed consent after reading patient information
|- Exclusion criteria||- Not providing informed consent or not capable of giving informed consent|
- Kidney transplantation
- End-stage renal disease (eGFR<15 ml/min) „h
- Insufficient understanding of Dutch or Turkish language
- Secondary forms of hypertension (to be excluded according to local guidelines) except cases when a secondary form of hypertension has been established or is likely but chosen treatment is drug therapy (for instance primary hyperaldosteronism, renovascular hypertension).
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2018|
|- planned closingdate||1-jul-2021|
|- Target number of participants||310|
|- Interventions||Feedback of actual drug levels measured in a dried blood spot (DBS) obtained by a finger prick combined with supported problem solving: firstly, barriers to adherence will be discussed and suggestions for modular interventions tailored to the underlying cause of non-adherence will be made. The control group will receive no feedback and supported problem solving. |
|- Primary outcome||- Determine whether measuring drug levels combined with personalized feedback leads to a decrease in resistant hypertension after 12 months of follow-up. |
|- Secondary outcome||- determine percentage of assumed resistant hypertension at baseline due to non-adherence|
- Determine the percentage of patients with partial or non-adherence at baseline who are adherent after 12 months of follow-up
- Determine whether the number of required antihypertensive drugs is lower in patients who receive feedback on drug levels than in patients who do not.
- cost-utility of the intervention versus usual care in resistant hypertention
- The number of patients fulfilling the definition of resistant hypertension after 3 and 6 months
T = 0 months
T = 3 months
T = 6 months
T = 12 months
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. Jorie Versmissen|
|- CONTACT for SCIENTIFIC QUERIES|| Laura Peeters|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: Resistant hypertension is a common health issue leading to high costs and suboptimal cardiovascular prevention. Non-adherence is one of the most common reasons, but proving non-adherence and, more importantly, improving adherence are challenging. We have developed a method to measure drug levels of the most commonly used antihypertensive drug in a dried blood spot (DBS) obtained by a finger prick.
Objective: To determine whether measuring drug levels combined with personalized feedback leads to a decrease in resistant hypertension after 12 months of follow-up due to improved adherence.
Study design: We will perform a randomised controlled trial in which half of the patients will undergo an intervention consisting of feedback on drug levels combined with supported problem-solving, while the other half will not receive any feedback on drug levels.
Study population: Patients with resistant hypertension (RH: uncontrolled hypertension despite a regimen of antihypertensive drugs from at least three classes including a diuretic). Patients need to use at least two drugs for which DBS-analysis is available. Patients who do not understand Dutch or Turkish or cannot give informed consent for another reason will be excluded. 392 patients will be included to be able to identify a difference in RH between the intervention group and the control group of 10%, taking into account a decrease in the control group due to study effect.
Intervention: Feedback of actual drug levels combined with supported problem solving: firstly, barriers to adherence will be discussed and suggestions for modular interventions tailored to the underlying cause of non-adherence will be made. A psychologist and a sociologist are involved to develop the training and to train the involved doctors to perform the supported problem solving. The control group will receive no feedback and supported problem solving.
Main study parameters/endpoints: Primary: the proportion of patients fulfilling the definition of resistant hypertension after one year. Secondary: the real number of patient with assumed resistant hypertension that is caused by non-adherence, cost effectiveness of the intervention, percentage of patients with resistant hypertension after 3 and 6 months
|- Main changes (audit trail)|
|- RECORD||27-dec-2017 - 12-okt-2018|