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Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy

This study has been terminated.
(Due to difficulty in recruitment and resource restraints)
Sponsor:
Information provided by (Responsible Party):
Anand Chockalingam, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01048125
First received: January 11, 2010
Last updated: November 22, 2016
Last verified: October 2016

January 11, 2010
November 22, 2016
August 2009
July 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01048125 on ClinicalTrials.gov Archive Site
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Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Cardiomyopathy
  • 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.
  • 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
    Interventions:
    • 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
  • 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
    Interventions:
    • 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 Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
21 Years to 90 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01048125
1141858
No
Not Provided
Not Provided
Anand Chockalingam, University of Missouri-Columbia
University of Missouri-Columbia
Not Provided
Principal Investigator: Anand Chockalingam, MD University of Missouri-Columbia
University of Missouri-Columbia
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP