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Resistente HYpertensie: MEten voor Resultaat op Controle Tensie


- candidate number28380
- NTR NumberNTR6914
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-dec-2017
- Secondary IDsNL63126.078.17 
- Public TitleResistente HYpertensie: MEten voor Resultaat op Controle Tensie
- Scientific TitleResistant HYpertension: MEasure to Reach Targets
- ACRONYMRHYME-RCT
- hypothesisMeasuring 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) studiedTherapy 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 receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2018
- planned closingdate
- Target number of participants310
- InterventionsFeedback 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
- TimepointsInclusion
T = 0 months
T = 3 months
T = 6 months
T = 12 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Jorie Versmissen
- CONTACT for SCIENTIFIC QUERIES Laura Peeters
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD27-dec-2017 - 5-jan-2018


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl