The Effect of Heart Rate on Cardiac Index in Patients Wit... | NCT01241838

Studies
The Effect of Heart Rate on Cardiac Index in Patients With Left Ventricular Hypertrophy

NCT01241838

Sponsor

University of Aarhus

Status

Terminated

Last Update Posted

Aug 6, 2012Estimated

Enrollment

11Actual

Phase

Not Applicable

Conditions

Left Ventricular Hypertrophy
Diastolic Dysfunction
Heart Failure
Heart Rate

Interventions

Pacemaker

Countries

Denmark

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

Aug 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient no of patients eligible for enrollment.

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Nov 15, 2010

First Submission Date that Met QC Criteria

Nov 15, 2010

First Posted Date

Nov 16, 2010Estimated

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

Aug 3, 2012

Last Update Posted Date

Aug 6, 2012Estimated

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 compare the effect of heart rate on cardiac index in patients with or without left ventricular hypertrophy. The study will be conducted in postoperative heart surgery patients with a pacemaker.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal left ventricular size	Placebo Comparator	Postoperative patient with normal left ventricular size	Device: Pacemaker
Left ventricular hypertrophy	Active Comparator	Postoperative patient with left ventricular hypertrophy	Device: Pacemaker

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pacemaker	Device	Routine postoperative temporary pacemaker Rate change of 65-80-95-110-125 beats/second in random order at day 3-4 after operation	Left ventricular hypertrophy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiac index		At heart rates 65-80-95-110-125

Secondary Outcomes

Measure	Description	Time Frame
Mean arterial blood pressure		At heart rates 65-80-95-110-125
Ejection fraction	Echocardiographic index of systolic function	Heart rates of 65-80-95-110-120

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Scheduled heart surgery including thoracotomy
Ejection fraction > 45%
Duration of QRS complex < 120 milliseconds
Sinus rhythm
Planned perioperative temporary pacemaker

Group: Left ventricular hypertrophy:

Thickness of interventricular septum and posterior wall >11 mm.

Group: No left ventricular hypertrophy:

Thickness of interventricular septum and posterior wall <11 mm.

Exclusion Criteria:

Active endocarditis
Severe mitral insufficiency
No patient consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Juhl-Olsen, M.D.	Department of Anaesthesiology, Århus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesiology, Århus University Hospital		Århus N		8200	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D017379	Hypertrophy, Left Ventricular
D006333	Heart Failure

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided