Prevalence of Masked Hypertension in Nephrological Patients | NCT02663336

Studies
Prevalence of Masked Hypertension in Nephrological Patients

NCT02663336

Sponsor

Waid City Hospital, Zurich

Status

Unknown status

Last Update Posted

Oct 28, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Masked Hypertension

Interventions

Comparison ABPM with OBPM

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Jan 2023Estimated

Completion Date

Nov 2023Estimated

First Submitted Date

Jan 18, 2016

First Submission Date that Met QC Criteria

Jan 21, 2016

First Posted Date

Jan 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2021

Last Update Posted Date

Oct 28, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the percentage of patients with masked hypertension in a population with chronic kidney disease. The investigators goal is to register prospectively ambulatory blood pressure measurement results of patients of a nephrological outpatient clinic with normal office blood pressure to finally find the percentage of masked hypertension in this population.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CKD patients		Patients with chronic kidney disease, with diagnosed arterial hypertension and normal blood pressure during office blood pressure measurement. Comparison of ambulatory blood pressure (ABPM) with office blood pressure measurements (OBPM).	Other: Comparison ABPM with OBPM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Comparison ABPM with OBPM	Other	No interventions	CKD patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with uncontrolled masked hypertension assessed by comparison of ambulatory blood pressure with office blood pressure		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 20-90 years
Known arterial hypertension and antihypertensive medical treatment
Office blood pressure < 140 mmHg systolic and <90 mmHg diastolic

Exclusion Criteria:

Age <20 or >90 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic kidney disease of the nephrological outpatient clinic of Waidspital with normal office blood pressure in the context of diagnosed arterial hypertension with or without antihypertensive medication

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andreas Schleich	Contact	-41 44 36621 11		Andreas.schleich@waid.zuerich.ch

Overall Officials

Name	Affiliation	Role
Andreas Schleich	Stadtspital Waid Zurich Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stadtspital Waid Zurich	Recruiting	Zurich		8037	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D059468	Masked Hypertension
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D051437	Renal Insufficiency

Browse Leaves

Not provided

Browse Branches

Not provided