RAS Peptide Profiles in Patients With Treatment-resistant Arterial Hypertension

NCT ID: NCT02962778

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-10-11

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.

Conditions

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Hypertension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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treatment-resistant hypertension

patients with Treatment-resistant arterial hypertension receiving standard antihypertensive treatment with at least 3 antihypertensive agents including one diuretic

No interventions assigned to this group

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manuel Haschke, MD, Dr.

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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TRHT-01 Study

Identifier Type: -

Identifier Source: org_study_id

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