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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01241838
• Other study ID #: 1717
• Status: Terminated
• Phase: N/A
• First received: November 15, 2010
• Last updated: August 3, 2012
• Start date: February 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Heart Failure
• Heart Rate
• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Hypertrophy

Intervention

Device:
• Pacemaker
Routine postoperative temporary pacemaker Rate change of 65-80-95-110-125 beats/second in random order at day 3-4 after operation

Locations

Country	Name	City	State
Denmark	Department of Anaesthesiology, Århus University Hospital	Århus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac index		At heart rates 65-80-95-110-125	No
Secondary	Mean arterial blood pressure		At heart rates 65-80-95-110-125	No
Secondary	Ejection fraction	Echocardiographic index of systolic function	Heart rates of 65-80-95-110-120	No
Secondary	Strain	Echocardiographic index of systolic function	Heart rates of 65-80-95-110-125	No
Secondary	S-max	Echocardiographic index of systolic function	Heart rates of 65-80-95-110-125 beats per second	No
Secondary	E/E'	Echocardiographic index of diastolic function	Heart rates of 65-80-95-110-125 beats per second	No
Secondary	E/A ratio	Echocardiographic index of diastolic function	Heart rates of 65-80-95-110-125 beats per second	No
Secondary	E'/A' ratio	Echocardiographic index of diastolic function	Heart rates of 65-80-95-110-125 beats per second	No
Secondary	Isovolumetric relaxation index	Echocardiographic index of diastolic function	Heart rates of 65-80-95-110-125 beats per second	No
Secondary	IVRT/IVRT'	Echocardiographic index of diastolic function	Heart rates of 65-80-95-110-125 beats per second	No
Secondary	End diastolic volume	Volume of left ventricle and end diastole	Heart rates of 65-80-95-110-125 beats per second	No
Secondary	End systolic volume	Volume of left ventricle at end systole	Heart rates of 65-80-95-110-125 beats per second	No