Clinical trial NCT02962778: RAS Peptide Profiles in Patients With Treatment-resistant Arterial Hypertension
Official title: Renin-angiotensin-system (RAS) Peptide Profiles in Patients With Treatment-resistant Arterial Hypertension (TRHT-01 Study). An Observational Single Centre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: treatment-resistant
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female outpatients fulfilling criteria for treatment-resistant arterial hypertension

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: RAS peptide concentrations in plasma
timeFrame: baseline, 4h after observed drug intake and steady-state sample
Secondary outcomes:
measure: Antihypertensive drug concentrations in plasma
timeFrame: baseline, 4h after observed drug intake and steady-state sample
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Manuel Haschke, MD, Dr.
role: PRINCIPAL_INVESTIGATOR
References: