Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy

• Sponsor: University of Missouri-Columbia (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01048125
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Aug 1, 2009
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

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.

Outcome Measures

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. [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anand Chockalingam, Professor, Cardiology, University of Missouri-Columbia
• ClinicalTrials.gov Identifier: NCT01048125
• Other Study ID Numbers: 1141858
• First Posted: Jan 13, 2010
• Last Update Posted: Nov 23, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by Anand Chockalingam, Professor, Cardiology, University of Missouri-Columbia: Stress-induced cardiomyopathy; Takotsubo cardiomyopathy
• Additional relevant MeSH terms: Cardiomyopathies; Takotsubo Cardiomyopathy; Nitroprusside; Phenylephrine; Oxymetazoline

Study Results

Participant Flow

Recruitment Details	2 participants were consented, but due to difficulty in recruitment and resource restraints the study did not progress as expected and was closed.

Arm/Group Title	Study Group	Control
Arm/Group Description	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	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 Sympathetic Nerve Activity: Resting Sympathetic Nerve Activity 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. 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
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Study Group	Control	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years	0
Between 18 and 65 years	0
>=65 years	0
Gender () []
Female	0
Male	0
Region of Enrollment () []
United States	0

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

Due to difficulty in recruitment and resource restraints the study did not progress as expected and was closed.

Arm/Group Title	Study Group	Control
Arm/Group Description	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	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 Sympathetic Nerve Activity: Resting Sympathetic Nerve Activity 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. 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
Measure Participants	0	0

Adverse Events

Arm/Group Title	Study Group		Control
Arm/Group Description	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		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
All Cause Mortality
	Study Group		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Study Group		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Study Group		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

2 participants were consented, but due to difficulty in recruitment and resource restraints the study did not progress as expected and was closed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.