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New Biomarkers and Difficult-to-treat Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03034265
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : December 20, 2017
University of Zurich
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
The purpose of this study is to determine the concentrations and variabilities of urinary exosomal sodium channels and plasma angiotensins in patients with difficult-to-treat arterial hypertension and to investigate their dependency on clinical parameters and sampling conditions.

Condition or disease

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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of New Biomarkers for the Classification and Monitoring of Difficult-to-treat Arterial Hypertension: Prospective Observational Study
Actual Study Start Date : May 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Plasma concentration of Ang peptides [ Time Frame: 2nd scheduled visit (5 days to 4 weeks after 1st visit) ]
  2. Urinary concentration of exosomal Na channel proteins [ Time Frame: 2nd scheduled visit (5 days to 4 weeks after 1st visit) ]

Secondary Outcome Measures :
  1. 24h urinary Na excretion [ Time Frame: 2nd scheduled visit (5 days to 4 weeks after 1st visit) ]
  2. Plasma renin concentration [ Time Frame: 2nd scheduled visit (5 days to 4 weeks after 1st visit) ]
  3. Plasma aldosterone concentration [ Time Frame: 2nd scheduled visit (5 days to 4 weeks after 1st visit) ]
  4. Repeatability of Ang peptide and urinary exosomal Na channel concentrations under spontaneous vs. standardized laboratory conditions. [ Time Frame: 1st visit vs. 2nd scheduled visit (5 days to 4 weeks after 1st visit) ]
    Statistical agreement is tested.

Biospecimen Retention:   Samples Without DNA
blood, urine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Amblatory patients with difficult-to-treat hypertension referred to the hypertension clinic for evaluation

Inclusion Criteria:

  • Patients with ≥2 antihypertensive drugs for ≥3 months
  • Reported blood pressure ≥140/90 mmHg and/or patient reported as having medically uncontrolled hypertension by the referring physician
  • Age ≥18 years, capacity to provide and granted written informed consent

Exclusion Criteria:

  • Chronic stage 4-5 renal insufficiency; glomerulonephritis, liver insufficiency (Child-Pugh B or C), chronic obstructive pulmonary disease Global Initiative for Obstructive Lung Disease grade 4; chronic heart failure New York Heart Association class IV
  • Known secondary hypertension
  • Mandatory RAAS-blockers (e.g. converting enzyme inhibitors, angiotensin type 1 receptor blockers), beta-adrenoceptor blockers, centrally acting sympatholytics and diuretics that cannot be paused adequately before visit 2
  • Mean sitting office blood pressure >190/110 mmHg measured 3x on visit 1
  • Normotension on visit 1 (mean seated office blood pressure measured 3x <140/90 mmHg)
  • Insufficient knowledge of project language and absence of an interpreter for study communications
  • Pregnancy or lactation
  • Scheduled clinical visit 2 outside routine workflow time-line (<5 or >31 days after visit 1)
  • Inability to follow procedures (e.g. relevant psychiatric disorder or dementia)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03034265

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Department of Nephrology and Hypertension, Inselspital, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Zurich
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Principal Investigator: Jürgen Bohlender, M.D. Inselspital, Bern University Hospital, Freiburgstr. 4, 3010 Bern, Switzerland

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Responsible Party: University Hospital Inselspital, Berne Identifier: NCT03034265    
Other Study ID Numbers: Study 3003
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Interested third parties may have access to project data by contacting the leading investigator. Only anonymous data are shared, also in case with third parties with lower data protection standards than Swiss or European Union, to safeguard confidentiality.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
hypertension; exosome; angiotensin; sodium channel; kidney; aldosterone; renin; urine
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases