Left Ventricular HypertrophyNCT01241838
The Effect of Heart Rate on Cardiac Index in Patients With Left Ventricular Hypertrophy
A study testing Pacemaker in people with Left Ventricular Hypertrophy and Diastolic Dysfunction, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Left Ventricular Hypertrophy, Diastolic Dysfunction, Heart Failure
- What is being tested?
- Pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled heart surgery including thoracotomy
- Ejection fraction > 45%
- Duration of QRS complex < 120 milliseconds
- Sinus rhythm
- Planned perioperative temporary pacemaker
- Group: Left ventricular hypertrophy:
Show all 9Show fewer
- Thickness of interventricular septum and posterior wall >11 mm.
- Group: No left ventricular hypertrophy:
- Thickness of interventricular septum and posterior wall <11 mm.
Who cannot join
- Active endocarditis
- Severe mitral insufficiency
- No patient consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anaesthesiology, Århus University Hospital
Århus N, 8200
About this study
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.
- Being tested
- Pacemaker
- Keywords
- Heart failure, Left ventricular hypertrophy, Diastolic dysfunction
- Medical subject headings
- Hypertrophy, Left Ventricular, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacemakerDevice
Routine postoperative temporary pacemaker Rate change of 65-80-95-110-125 beats/second in random order at day 3-4 after operation
| Study group | Role | What they receive |
|---|---|---|
| Normal left ventricular size | Placebo comparator | Postoperative patient with normal left ventricular size Receives: Device: Pacemaker |
| Left ventricular hypertrophy | Active comparator | Postoperative patient with left ventricular hypertrophy Receives: Device: Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac index
Measured: At heart rates 65-80-95-110-125
Secondary outcomes (11)
Mean arterial blood pressure
Measured: At heart rates 65-80-95-110-125
Ejection fraction
Echocardiographic index of systolic function
Measured: Heart rates of 65-80-95-110-120
Strain
Echocardiographic index of systolic function
Measured: Heart rates of 65-80-95-110-125
S-max
Echocardiographic index of systolic function
Measured: Heart rates of 65-80-95-110-125 beats per second
E/E'
Echocardiographic index of diastolic function
Measured: Heart rates of 65-80-95-110-125 beats per second
E/A ratio
Echocardiographic index of diastolic function
Measured: Heart rates of 65-80-95-110-125 beats per second
E'/A' ratio
Echocardiographic index of diastolic function
Measured: Heart rates of 65-80-95-110-125 beats per second
Isovolumetric relaxation index
Echocardiographic index of diastolic function
Measured: Heart rates of 65-80-95-110-125 beats per second
IVRT/IVRT'
Echocardiographic index of diastolic function
Measured: Heart rates of 65-80-95-110-125 beats per second
End diastolic volume
Volume of left ventricle and end diastole
Measured: Heart rates of 65-80-95-110-125 beats per second
End systolic volume
Volume of left ventricle at end systole
Measured: Heart rates of 65-80-95-110-125 beats per second
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startFeb 2011
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Insufficient no of patients eligible for enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular HypertrophyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Juhl-Olsen, M.D., Principal investigator, Department of Anaesthesiology, Århus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241838
- Sponsor's protocol ID
- 1717
- Status last verified
- Aug 2012
- First submitted
- 15 Nov 2010
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Heart Rate on Cardiac Index in Patients With Left Ventricular Hypertrophy
- ClinicalTrials.gov ID
- NCT01241838
- Acronym / sponsor ID
- 1717
- Keywords
- Heart failure, Left ventricular hypertrophy, Diastolic dysfunction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient no of patients eligible for enrollment.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal left ventricular size | Placebo comparator | Device: PacemakerPostoperative patient with normal left ventricular size |
| Left ventricular hypertrophy | Active comparator | Device: PacemakerPostoperative patient with left ventricular hypertrophy |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Scheduled heart surgery including thoracotomy
- Ejection fraction > 45%
- Duration of QRS complex < 120 milliseconds
- Sinus rhythm
- Planned perioperative temporary pacemaker
Key exclusion criteria (3 listed)
- Active endocarditis
- Severe mitral insufficiency
- No patient consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PacemakerRoutine postoperative temporary pacemaker Rate change of 65-80-95-110-125 beats/second in random order at day 3-4 after operation | Device | Left ventricular hypertrophy, Normal left ventricular size |
Primary outcome
Cardiac index
Time frame: At heart rates 65-80-95-110-125
11 secondary outcomes
Mean arterial blood pressure
Time frame: At heart rates 65-80-95-110-125
Ejection fraction
Time frame: Heart rates of 65-80-95-110-120
Strain
Time frame: Heart rates of 65-80-95-110-125
S-max
Time frame: Heart rates of 65-80-95-110-125 beats per second
E/E'
Time frame: Heart rates of 65-80-95-110-125 beats per second
E/A ratio
Time frame: Heart rates of 65-80-95-110-125 beats per second
E'/A' ratio
Time frame: Heart rates of 65-80-95-110-125 beats per second
Isovolumetric relaxation index
Time frame: Heart rates of 65-80-95-110-125 beats per second
IVRT/IVRT'
Time frame: Heart rates of 65-80-95-110-125 beats per second
End diastolic volume
Time frame: Heart rates of 65-80-95-110-125 beats per second
End systolic volume
Time frame: Heart rates of 65-80-95-110-125 beats per second
Results and safety
The study was stopped early (reason given: Insufficient no of patients eligible for enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Juhl-Olsen, M.D. principal investigator
Department of Anaesthesiology, Århus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker in people with Left Ventricular Hypertrophy and Diastolic Dysfunction, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient no of patients eligible for enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac index (time frame: At heart rates 65-80-95-110-125). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2012.