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TerminatedNCT01241838Updated Aug 6, 2012

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

An interventional study of Pacemaker in Left Ventricular Hypertrophy, Diastolic Dysfunction and Heart Failure, sponsored by University of Aarhus. Terminated at 1 site in Denmark. Open to participants aged 30 Years to 90 Years. Per ClinicalTrials.gov, last updated 2012-08-06.

Sponsored by University of Aarhus · Not applicable and Interventional

Why this study was terminated
Insufficient no of patients eligible for enrollment.
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Non-randomized
Ages
30 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Heart failure
  • Left ventricular hypertrophy
  • Diastolic dysfunction
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 11 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Active endocarditis
  • Severe mitral insufficiency
  • No patient consent
05

Study design

Phase
Not applicable
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Placebo comparator
    Normal left ventricular size

    Postoperative patient with normal left ventricular size

    Device: Pacemaker

  • Active comparator
    Left ventricular hypertrophy

    Postoperative patient with left ventricular hypertrophy

    Device: Pacemaker

Interventions

  • DevicePacemaker

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

06

What researchers measure

Primary outcomes

  1. Cardiac index

    Time frame: At heart rates 65-80-95-110-125

Secondary outcomes

  1. Mean arterial blood pressure

    Time frame: At heart rates 65-80-95-110-125

  2. Ejection fraction

    Echocardiographic index of systolic function

    Time frame: Heart rates of 65-80-95-110-120

  3. Strain

    Echocardiographic index of systolic function

    Time frame: Heart rates of 65-80-95-110-125

  4. S-max

    Echocardiographic index of systolic function

    Time frame: Heart rates of 65-80-95-110-125 beats per second

  5. E/E'

    Echocardiographic index of diastolic function

    Time frame: Heart rates of 65-80-95-110-125 beats per second

  6. E/A ratio

    Echocardiographic index of diastolic function

    Time frame: Heart rates of 65-80-95-110-125 beats per second

  7. E'/A' ratio

    Echocardiographic index of diastolic function

    Time frame: Heart rates of 65-80-95-110-125 beats per second

  8. Isovolumetric relaxation index

    Echocardiographic index of diastolic function

    Time frame: Heart rates of 65-80-95-110-125 beats per second

  9. IVRT/IVRT'

    Echocardiographic index of diastolic function

    Time frame: Heart rates of 65-80-95-110-125 beats per second

  10. End diastolic volume

    Volume of left ventricle and end diastole

    Time frame: Heart rates of 65-80-95-110-125 beats per second

  11. End systolic volume

    Volume of left ventricle at end systole

    Time frame: Heart rates of 65-80-95-110-125 beats per second

07

Study locations

1 site
  • Department of Anaesthesiology, Århus University Hospital
    Århus N, 8200, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01241838
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
Nov 16, 2010
Start date
Feb 2011
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Aug 6, 2012

Study contacts

Peter Juhl-Olsen, M.D.
principal investigator · Department of Anaesthesiology, Århus University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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