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

This study has been terminated.
(Insufficient no of patients eligible for enrollment.)
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01241838
First received: November 15, 2010
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Left Ventricular Hypertrophy
Diastolic Dysfunction
Heart Failure
Heart Rate
Device: Pacemaker

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Effect of Heart Rate on Cardiac Index in Patients With Left Ventricular Hypertrophy

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Cardiac index [ Time Frame: At heart rates 65-80-95-110-125 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean arterial blood pressure [ Time Frame: At heart rates 65-80-95-110-125 ] [ Designated as safety issue: No ]
  • Ejection fraction [ Time Frame: Heart rates of 65-80-95-110-120 ] [ Designated as safety issue: No ]
    Echocardiographic index of systolic function

  • Strain [ Time Frame: Heart rates of 65-80-95-110-125 ] [ Designated as safety issue: No ]
    Echocardiographic index of systolic function

  • S-max [ Time Frame: Heart rates of 65-80-95-110-125 beats per second ] [ Designated as safety issue: No ]
    Echocardiographic index of systolic function

  • E/E' [ Time Frame: Heart rates of 65-80-95-110-125 beats per second ] [ Designated as safety issue: No ]
    Echocardiographic index of diastolic function

  • E/A ratio [ Time Frame: Heart rates of 65-80-95-110-125 beats per second ] [ Designated as safety issue: No ]
    Echocardiographic index of diastolic function

  • E'/A' ratio [ Time Frame: Heart rates of 65-80-95-110-125 beats per second ] [ Designated as safety issue: No ]
    Echocardiographic index of diastolic function

  • Isovolumetric relaxation index [ Time Frame: Heart rates of 65-80-95-110-125 beats per second ] [ Designated as safety issue: No ]
    Echocardiographic index of diastolic function

  • IVRT/IVRT' [ Time Frame: Heart rates of 65-80-95-110-125 beats per second ] [ Designated as safety issue: No ]
    Echocardiographic index of diastolic function

  • End diastolic volume [ Time Frame: Heart rates of 65-80-95-110-125 beats per second ] [ Designated as safety issue: No ]
    Volume of left ventricle and end diastole

  • End systolic volume [ Time Frame: Heart rates of 65-80-95-110-125 beats per second ] [ Designated as safety issue: No ]
    Volume of left ventricle at end systole


Enrollment: 11
Study Start Date: February 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Normal left ventricular size
Postoperative patient with normal left ventricular size
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
Active Comparator: Left ventricular hypertrophy
Postoperative patient with left ventricular hypertrophy
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

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241838

Locations
Denmark
Department of Anaesthesiology, Århus University Hospital
Århus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Peter Juhl-Olsen, M.D. Department of Anaesthesiology, Århus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01241838     History of Changes
Other Study ID Numbers: 1717
Study First Received: November 15, 2010
Last Updated: August 3, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Heart failure
Left ventricular hypertrophy
Diastolic dysfunction

Additional relevant MeSH terms:
Heart Failure
Hypertrophy
Hypertrophy, Left Ventricular
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly

ClinicalTrials.gov processed this record on July 29, 2014