Vascular Sensitivity to Adrenergic Agonists in Patients W... | NCT00782782

Studies
Vascular Sensitivity to Adrenergic Agonists in Patients With CHF and in Healthy Subjects

NCT00782782

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Oct 31, 2008Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Congestive Heart Failure

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

Oct 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Oct 26, 2008

First Submission Date that Met QC Criteria

Oct 28, 2008

First Posted Date

Oct 31, 2008Estimated

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 28, 2008

Last Update Posted Date

Oct 31, 2008Estimated

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

Congestive Heart failure (CHF) is asociated with changes in cardiac function and vascular responses. The aim of this study is to characterize these differences. Our hypothesis is, that there are differences in vascular responses between healthy subjects and patients with CHF.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

80Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
vascular sensitivity (ED50) and response (Emax) to dexmedetomidine, phenylephrine, isoproterenol and terbutaline		3 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with congestive heart failure NYHA I-II
Stable clinical condition

Exclusion Criteria:

Resting systolic blood pressure < 100
Resting heart rate < 50
Hypersensitivity to dexmedetomidine, phenylephrine, isoproterenol, terbutaline

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with congestive heart failure NYHA I-II and healthy subjects

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mordechai Muszkat	Hadassah University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah University Hospital		Jerusalem		92110	Israel

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided