RAS Peptide Profiles in Patients With Treatment-resistant Arterial Hypertension

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02962778
• Other study ID #: TRHT-01 Study
• Status: Completed
• Phase: N/A
• First received: November 9, 2016
• Last updated: February 26, 2018
• Start date: October 2016
• Est. completion date: October 11, 2017

Study information

• Verified date: February 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 11, 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RAS peptide concentrations in plasma		baseline, 4h after observed drug intake and steady-state sample
Secondary	Antihypertensive drug concentrations in plasma		baseline, 4h after observed drug intake and steady-state sample