Medication Adherence and "True" Resistance in Patients With Resistant Hypertension

Charité University Medicine Berlin

Status: Unknown

Conditions: Hypertensive Disease; Hypertension, Resistant to Conventional Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT02128386

EA1/328/13

Details and patient eligibility

About

The purpose of this study is to estimate the proportion of patients with "true" resistance among patients referred to the Medical Outpatient Department of the Charité - Universitätsmedizin Berlin with the diagnosis "resistant hypertension". Moreover, data on medication adherence will be collected based on therapeutic drug monitoring and on the answers to validated questionnaires. Finally, efficacy, safety and costs of renal sympathetic denervation will be compared to an intensified drug treatment in an exploratory way.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female or male adult patients with arterial hypertension and admission diagnosis of "resistant hypertension"
• Informed consent
• Exclusion of secondary arterial hypertension
• Kidney function (estimated glomerular filtration rate [eGFR] ≥ 45 ml/min/1.73 m2)

Exclusion criteria

• Age < 18 years
• Secondary arterial hypertension
• Type 1 Diabetes mellitus
• Unstable coronary heart disease, myocardial infarction or stroke in the last 6 months
• Psychiatric diseases
• Significant carotid stenosis (> 70%)
• Pregnancy
• Chronic kidney disease (eGFR < 45 ml/min/1.73 m2)
• Severe liver injury (elevation of transaminases more than twofold the upper limit of normal)
• Abuse of alcohol or illegal drugs

Trial design

50 participants in 2 patient groups

Renal sympathetic denervation

Description:

Olmesartan 40 mg once daily + Amlodipine 5 or 10 mg once daily + Hydrochlorothiazide 25 mg one daily plus renal sympathetic denervation

Intensified antihypertensive treatment

Description:

Olmesartan 40 mg once daily + Amlodipine 5 or 10 mg once daily + Hydrochlorothiazide 25 mg one daily plus second-line antihypertensive agents (e.g. mineralocorticoid receptor antagonists or alpha-1-blockers)