Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy

NCT01048125 | Terminated Results

• 1 other identifier: 1141858
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy

Keywords

Stress-induced cardiomyopathy; Takotsubo cardiomyopathy

Outcome Measures

Primary Outcomes (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

Study Arms (2)

Study group

EXPERIMENTAL

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; Behavioral: Mental Stress Test (Color Word Test); Drug: The Modified Oxford Technique for Baroreflex Sensitivity; Other: Cold Pressor Test; Device: Echocardiographic evaluation

Control

ACTIVE COMPARATOR

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; Behavioral: Mental Stress Test (Color Word Test); Drug: The Modified Oxford Technique for Baroreflex Sensitivity; Other: Cold Pressor Test; Device: Echocardiographic evaluation

Interventions

Sympathetic Nerve Activity DEVICE

Resting Sympathetic Nerve Activity

Control; Study group

Mental Stress Test (Color Word Test) BEHAVIORAL

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.

Control; Study group

The Modified Oxford Technique for Baroreflex Sensitivity DRUG

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.

Also known as: Sodium Nitroprusside, Phenylephrine hydrochloride

Control; Study group

Cold Pressor Test OTHER

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.

Control; Study group

Echocardiographic evaluation DEVICE

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.

Control; Study group

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of stress cardiomyopathy in the past

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Cardiomyopathies; Takotsubo Cardiomyopathy

Interventions

Nitroprusside; Phenylephrine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Ferricyanides; Cyanides; Anions; Ions; Electrolytes; Inorganic Chemicals; Ferric Compounds; Iron Compounds; Hydrogen Cyanide; Nitrogen Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Anand Chockalingam
• Organization: University of Missouri-Columbia

chockalingama@health.missouri.edu

573/882-2296

Study Officials

• Anand Chockalingam, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Cardiology

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 13, 2010
• Study Start: August 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 23, 2016
• Results First Posted: November 23, 2016

Record last verified: 2016-10

Locations

US (1)