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Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT01048125
Recruitment Status : Terminated (Due to difficulty in recruitment and resource restraints)
First Posted : January 13, 2010
Results First Posted : November 23, 2016
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
Anand Chockalingam, University of Missouri-Columbia

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cardiomyopathy Device: Sympathetic Nerve Activity Behavioral: Mental Stress Test (Color Word Test) Drug: The Modified Oxford Technique for Baroreflex Sensitivity Other: Cold Pressor Test Device: Echocardiographic evaluation Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy
Study Start Date : August 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources

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
Device: Sympathetic Nerve Activity
Resting Sympathetic Nerve Activity
Behavioral: Mental Stress Test (Color Word Test)
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.
Drug: The Modified Oxford Technique for Baroreflex Sensitivity
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:
  • Sodium Nitroprusside
  • Phenylephrine hydrochloride
Other: Cold Pressor Test
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.
Device: Echocardiographic evaluation
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
Device: Sympathetic Nerve Activity
Resting Sympathetic Nerve Activity
Behavioral: Mental Stress Test (Color Word Test)
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.
Drug: The Modified Oxford Technique for Baroreflex Sensitivity
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:
  • Sodium Nitroprusside
  • Phenylephrine hydrochloride
Other: Cold Pressor Test
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.
Device: Echocardiographic evaluation
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.



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048125


Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Anand Chockalingam, MD University of Missouri-Columbia

Responsible Party: Anand Chockalingam, Professor, Cardiology, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01048125     History of Changes
Other Study ID Numbers: 1141858
First Posted: January 13, 2010    Key Record Dates
Results First Posted: November 23, 2016
Last Update Posted: November 23, 2016
Last Verified: October 2016

Keywords provided by Anand Chockalingam, University of Missouri-Columbia:
Stress-induced cardiomyopathy
Takotsubo cardiomyopathy

Additional relevant MeSH terms:
Takotsubo Cardiomyopathy
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction
Phenylephrine
Oxymetazoline
Nitroprusside
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antihypertensive Agents
Vasodilator Agents
Nitric Oxide Donors