Sympathetic Innervation of the Heart and Cardiac Resynchr... | NCT00567645

Studies
Sympathetic Innervation of the Heart and Cardiac Resynchronization Therapy(CRT)

NCT00567645

Sponsor

University Medical Center Groningen

Status

Withdrawn

Last Update Posted

May 13, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Sympathetic Innervation
Chronic Heart Failure

Interventions

Not provided

Countries

Netherlands

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

May 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 4, 2007

First Submission Date that Met QC Criteria

Dec 4, 2007

First Posted Date

Dec 5, 2007Estimated

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

May 12, 2016

Last Update Posted Date

May 13, 2016Estimated

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 assess whether baseline sympathetic innervation in patients with chronic heart failure (CHF) is predictive for response to cardiac resynchronization therapy (CRT). And to assess whether response to CRT coincides with restoration of regional sympathetic innervation.

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

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sympathetic innervation in patients with chronic heart failure (CHF)		6 months

Secondary Outcomes

Measure	Description	Time Frame
NYHA class Echocardiographic parameters: LVEDD, LVESD, LVEF, LVESV,IVMD, and septal to lateral delay Hospitalization for heart failure Maximal oxygen consumption NT pro-BNP changes		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Indication for CRT
Stable optimal medication
Non ischemic cardiomyopathy

Exclusion Criteria:

Age less then 18 years
Previous CRT
Clinically relevant valvular heart disease or coronary artery disease
Acute or chronic infection
Untreated clinical hypo- or hyperthyroidism or < 3 months euthyroidism
Uncontrolled hypertension, defined as a systolic blood pressure > 160 mm Hg and/or a diastolic blood pressure > 95 mm Hg
A concurrent medical condition (i.e. alcohol or drug abuse or a severe progressive extra cardiac disease or M. Parkinson) or is unlikely to comply with the protocol
Participation to a previous protocol involving radioactivity in the past year
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

chronic heart failure patients with CRT

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Isabelle C. Van Gelder, Prof	University Medical Center Groningen, departmen cardiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Groningen		Groningen	Provincie Groningen	9700 RB	Netherlands