NCT01241838

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 6, 2012

Status Verified

August 1, 2012

Enrollment Period

1.5 years

First QC Date

November 15, 2010

Last Update Submit

August 3, 2012

Conditions

Left Ventricular HypertrophyDiastolic DysfunctionHeart FailureHeart Rate

Keywords

Heart failureLeft ventricular hypertrophyDiastolic dysfunction

Outcome Measures

Primary Outcomes (1)

  • Cardiac index

    At heart rates 65-80-95-110-125

Secondary Outcomes (11)

  • Mean arterial blood pressure

    At heart rates 65-80-95-110-125

  • Ejection fraction

    Heart rates of 65-80-95-110-120

  • Strain

    Heart rates of 65-80-95-110-125

  • S-max

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

  • E/E'

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

  • +6 more secondary outcomes

Study Arms (2)

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

PacemakerDEVICE

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 hypertrophyNormal left ventricular size

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Active endocarditis
  • Severe mitral insufficiency
  • No patient consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology, Århus University Hospital

Århus N, 8200, Denmark

Location

MeSH Terms

Conditions

Hypertrophy, Left VentricularHeart Failure

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Juhl-Olsen, M.D.

    Department of Anaesthesiology, Århus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 16, 2010

Study Start

February 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 6, 2012

Record last verified: 2012-08

Locations

DK(1)