RAS Peptide Profiles in Patients With Treatment-resistant Arterial Hypertension

NCT02962778 | Completed

• 1 other identifier: TRHT-01 Study
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

treatment-resistant

Outcome Measures

Primary Outcomes (1)

• RAS peptide concentrations in plasma

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

Secondary Outcomes (1)

• Antihypertensive drug concentrations in plasma

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

Study Arms (1)

treatment-resistant hypertension

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female outpatients fulfilling criteria for treatment-resistant arterial hypertension

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples for concentration measurement of RAS peptides and quantification of antihypertensive drug concentrations

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Manuel Haschke, MD, Dr.

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 11, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 11, 2017
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)