RAS Peptide Profiles in Patients With Treatment-resistant Arterial Hypertension

Study Overview
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Brief Summary
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This study evaluates RAS peptides profiles in patients with treatment resistant arterial hypertension.

Detailed Description
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Selective quantification of RAS peptides in human plasma triggered investigations evaluating whether RAS peptides could be used as clinical biomarkers in patients receiving antihypertensive treatment. Drug-specific RAS profiles first characterized in healthy normotensive subjects (EKBB 255/12; ClinicalTrials.gov ID NCT01771783) are presently investigated in patients with newly diagnosed arterial hypertension (EKNZ 2015-081; clinicaltrials.gov identifier (ID) NCT02449811). With this observational study RAS peptide profiles will be characterized in patients with treatment resistant hypertension. Data generated by this study will show whether RAS peptide profiles merit further evaluation as clinical biomarkers in this complex patient group.

Official Title
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Renin-angiotensin-system (RAS) Peptide Profiles in Patients With Treatment-resistant Arterial Hypertension (TRHT-01 Study). An Observational Single Centre Study

Conditions
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Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion criteria Office blood pressure ≥ 140/90 mmHg and mean 24 hour blood pressure >130/80 mmHg on average, or >135/85 mmHg during the day, or > 120/70 mmHg during the night, despite concurrent use of 3 antihypertensive agents at optimal doses, including one diuretic OR Office blood pressure and 24 hour mean blood pressure controlled with four or more medications Age ≥ 18 years Ability to understand research procedures and to provide written informed consent Exclusion criteria Known secondary arterial hypertension at time of inclusion or diagnosis of secondary hypertension after study inclusion during routine work-up of treatment resistant hypertension Known obstructive sleep apnea at time of inclusion History of, or clinically relevant or uncontrolled cardiovascular disease (other than arterial hypertension), namely myocardial infarction within last 3 months or valvular heart disease with clinically relevant reflux or heart failure Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the research project or compliance with the research plan.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| treatment-resistant hypertension<br>patients with Treatment-resistant arterial hypertension receiving standard antihypertensive treatment with at least 3 antihypertensive agents including one diuretic | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RAS peptide concentrations in plasma |  | baseline, 4h after observed drug intake and steady-state sample | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antihypertensive drug concentrations in plasma |  | baseline, 4h after observed drug intake and steady-state sample | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment-resistant