- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01048125
Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy
Stress (Takotsubo) cardiomyopathy (SC) is a peculiar form of acute, reversible myocardial dysfunction predominantly affecting the apical and mid left ventricular segments.
In this institution over the last two to three years the investigators have identified more than a dozen patients with stress cardiomyopathy. The investigators' overarching goal is to characterize these individuals with the hope of identifying risk factors and developing strategies to prevent the occurrence of SC in situations where the likelihood in susceptible individuals may be high.
Study Overview
Status
Conditions
Detailed Description
Stress (Takotsubo) cardiomyopathy (SC) is a peculiar form of acute, reversible myocardial dysfunction predominantly affecting the apical and mid left ventricular segments. This was originally described in Japan but is increasingly recognized all over the world especially in older women. There is evidence to support that excess sympathetic activation and catecholamine surges are potential mechanisms that cause this temporary myocardial 'stunning'. The amount of catecholamines in circulation of patients with SC was 2 to 3-fold higher when compared to subjects with acute myocardial infarction related equivalent cardiac dysfunction [Wittstein, et al. NEJM, 2005].
In this institution over the last two to three years the investigators have identified more than a dozen patients with stress cardiomyopathy. This diagnosis has been confirmed by echocardiographic documentation of normalization of left ventricular function over a course of few days to weeks. The investigators' overarching goal is to further characterize these individuals with the hope of identifying risk factors and developing strategies to prevent the occurrence of SC in situations where the likelihood in susceptible individuals may be high.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65212
- University of Missouri
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of stress cardiomyopathy in the past
Exclusion Criteria:
- Coronary artery disease (CAD), primary coronary intervention (PCI) or coronary artery bypass graft (CABG)
- Cardiac dysfunction
- Heart failure
- Significant arrhythmias
- Severe chronic obstructive pulmonary disease (COPD)
- Diabetic neuropathy
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
Subjects with documented stress cardiomyopathy who would serve as the study group.
Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
|
Resting Sympathetic Nerve Activity
A printed word will be shown to the subject, displayed in a color different from the color it actually names.
The subject will be asked to say the color that the word is printed in as quickly as possible.
For example if the word "green" is written in blue ink, they will say "blue."
This mental stress procedure will be used to cause brief changes in heart rate and blood pressure.
Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride (150 µg).
Infusion of nitroprusside will decrease blood pressure approximately 10-15 mmHg below baseline values.
Subsequent phenylephrine infusion will increase blood pressure approximately 10-15 mmHg above baseline values.
Nitroprusside and phenylephrine have been used extensively to assess baroreflex sensitivity in healthy as well as heart failure populations.
Additionally, the dosages being used have been shown to minimize the risk of excessive decreases or increases in blood pressure.
Other Names:
The subject will be asked to place their hand in ice water for 2 minutes.
This procedure will be used to cause transient changes in sympathetic nerve activity, heart rate and blood pressure.
Transthoracic echocardiography with 2D, color and pulse Doppler will be employed in all of our subjects.
Baseline left ventricular function, systolic as well as diastolic, will be quantified.
|
Active Comparator: Control
Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions.
Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
|
Resting Sympathetic Nerve Activity
A printed word will be shown to the subject, displayed in a color different from the color it actually names.
The subject will be asked to say the color that the word is printed in as quickly as possible.
For example if the word "green" is written in blue ink, they will say "blue."
This mental stress procedure will be used to cause brief changes in heart rate and blood pressure.
Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride (150 µg).
Infusion of nitroprusside will decrease blood pressure approximately 10-15 mmHg below baseline values.
Subsequent phenylephrine infusion will increase blood pressure approximately 10-15 mmHg above baseline values.
Nitroprusside and phenylephrine have been used extensively to assess baroreflex sensitivity in healthy as well as heart failure populations.
Additionally, the dosages being used have been shown to minimize the risk of excessive decreases or increases in blood pressure.
Other Names:
The subject will be asked to place their hand in ice water for 2 minutes.
This procedure will be used to cause transient changes in sympathetic nerve activity, heart rate and blood pressure.
Transthoracic echocardiography with 2D, color and pulse Doppler will be employed in all of our subjects.
Baseline left ventricular function, systolic as well as diastolic, will be quantified.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Identifying Risk Factors and Developing Strategies to Prevent the Occurrence of Stress Cardiomyopathy in Situations Where the Likelihood in Susceptible Individuals May be High.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anand Chockalingam, MD, University of Missouri-Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Ventricular Dysfunction, Left
- Ventricular Dysfunction
- Cardiomyopathies
- Takotsubo Cardiomyopathy
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nitric Oxide Donors
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Phenylephrine
- Oxymetazoline
- Nitroprusside
Other Study ID Numbers
- 1141858
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