Effect of Medical Treatment on Longitudinal Function of t... | NCT02237794

Studies
Effect of Medical Treatment on Longitudinal Function of the Heart

NCT02237794

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Sep 11, 2014Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Heart Function

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

Oct 2016Estimated

Completion Date

Oct 2016Estimated

First Submitted Date

Sep 9, 2014

First Submission Date that Met QC Criteria

Sep 9, 2014

First Posted Date

Sep 11, 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 9, 2014

Last Update Posted Date

Sep 11, 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

The purpose of this study is to determine the effect of medical treatment on longitudinal myocardial function. Patients who have been hospitalized for reasons other than heart disease will be examined with Transthoracic Cardiography before and after medical treatment to determine change in myocardial function.

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
Patients Without Acute Heart Conditions		Patients without acute heart conditions who were hospitalized for other medical indications.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Longitudinal Myocardial Function	Analysis of longitudinal contractility of the heart by the calculation of the heart's strain factor before and after chronic medication treatment.	Two Years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospitalized patients receiving above-mentioned medications

Exclusion Criteria:

Patients suffering from heart conditions
Patients unable to undergo Echocardiography
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients hospitalized in an Internal Medicine Department of the Hillel Yaffe Medical Center having a variety of medical conditions and treated with a variety of medications including Beta Blockers, Calcium Channel Blockers, Angiotensine Converting Enzyme Inhibitors and diuretics and do not suffer from overt heart conditions.

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Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Said Younis, MD	Contact	972-5-446-66274		saidjy@gmail.com

Overall Officials

Name	Affiliation	Role
David Blondheim, MD	Hillel Yaffe Medical Center	Study Chair
Said Younis, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

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