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Completed

NCT Number: NCT02962778

RAS Peptide Profiles in Patients With Treatment-resistant Arterial Hypertension

This study evaluates RAS peptides profiles in patients with treatment resistant arterial hypertension.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. RAS peptide concentrations in plasma

    Time frame: baseline, 4h after observed drug intake and steady-state sample

Secondary outcomes

  1. Antihypertensive drug concentrations in plasma

    Time frame: baseline, 4h after observed drug intake and steady-state sample

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 11, 2016
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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