Right Ventricular Hypertrophy After Atrial Switch and Car... | NCT01430897

Studies
Right Ventricular Hypertrophy After Atrial Switch and Cardiovascular Magnetic Resonance (CMR) Findings

NCT01430897

Sponsor

University of Leipzig

Status

Completed

Last Update Posted

Sep 8, 2011Estimated

Enrollment

37Actual

Phase

Not provided

Conditions

Right Ventricular Hypertrophy
d-TGA

Interventions

Not provided

Countries

Germany

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 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Apr 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Sep 5, 2011

First Submission Date that Met QC Criteria

Sep 7, 2011

First Posted Date

Sep 8, 2011Estimated

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 7, 2011

Last Update Posted Date

Sep 8, 2011Estimated

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

Systemic RV hypertrophy and impaired systolic function occur after atrial switch (AS) in d-transposition of the great arteries (d-TGA). Echocardiography has limitation in the assessment of the right ventricle (RV).

In this study the investigators sought to evaluate systemic RV myocardial mass and function after AS for d-TGA and to analyze the role of excessive hypertrophy for ventricular function under special consideration of the interventricular septal (IVS) movement.

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

37Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligibility criteria were an AS operation in childhood for correction of d-TGA and the absence of associated hemodynamically significant heart defects.

Exclusion Criteria:

Exclusion criteria were usual CMR contraindications such as ferromagnetic metallic implants.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Thirty-seven consecutive patients who came to regular outpatient visits at our tertiary care institution were referred to CMR.

Patient parameters were compared to a control group of 25 healthy age matched volunteers.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthias Gutberlet, MD	University pf Leipzig - Heart Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Leipzig - Heart Center		Leipzig		04289	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12356407	Result	Hornung TS, Kilner PJ, Davlouros PA, Grothues F, Li W, Gatzoulis MA. Excessive right ventricular hypertrophic response in adults with the mustard procedure for transposition of the great arteries. Am J Cardiol. 2002 Oct 1;90(7):800-3. doi: 10.1016/s0002-9149(02)02619-x. No abstract available.

ID	Term
D017380	Hypertrophy, Right Ventricular
D006333	Heart Failure

ID	Term
D006332	Cardiomegaly
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D006984	Hypertrophy