Cardiorenal Syndrome in End-Stage Kidney Disease | NCT02238093

Studies
Cardiorenal Syndrome in End-Stage Kidney Disease

NCT02238093

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Sep 12, 2014Estimated

Enrollment

270Estimated

Phase

Not provided

Conditions

End-stage Renal Disease
Cardiorenal Syndrome
Heart Disease

Interventions

Not provided

Countries

Israel

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

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Feb 2015Estimated

Completion Date

Feb 2015Estimated

First Submitted Date

Sep 10, 2014

First Submission Date that Met QC Criteria

Sep 10, 2014

First Posted Date

Sep 12, 2014Estimated

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

Sep 10, 2014

Last Update Posted Date

Sep 12, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Cardiorenal Syndrome (CRS) is prevalent among end-stage renal disease (ESRD) patients. Recently, its prevalence is rising. There are several different clinical presentations of this syndrome. It has a high rate of morbidity and mortality.

The purpose of this study is to find the connection between the heart pathology and its effect on ESRD patients. This will aid in choosing the appropriate medical therapy for these patients, and hopefully, aid in increasing their quality of life, and decrease their morbidity and mortality.

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

270Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dialysis Patients		End-stage renal disease patients undergoing dialysis at the Hillel Yaffe Medical Center.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart Pathology Identification	Visual identification of heart pathology in ESRD patients using echocardiography by measuring the ejection fraction of the left-ventricle during the systolic and diastolic phases. Valvular pathology is measured by the size of the valve.	One hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

End-stage renal patients

Exclusion Criteria:

Cancer patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

End-stage renal disease patients undergoing dialysis at the Hillel Yaffe Medical Center.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Noa Berar-Yanay, MD	Contact	972-4-630-4115		noab@hy.health.gov.il

Overall Officials

Name	Affiliation	Role
Noa Berar-Yanay, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic
D059347	Cardio-Renal Syndrome
D006331	Heart Diseases

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided