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Sympathetic Heart Innervation in Patients With Tako-Tsubo Cardiomyopathy

NCT01524861 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-01-27

No results posted yet for this study

Summary

Stress (tako-tsubo) cardiomyopathy (SC) is a rapidly reversible form of acute heart failure reported to be triggered by stressful events and associated with a distinctive left ventricular (LV) contraction pattern.

SC mimics acute coronary syndrome and is accompanied by reversible left ventricular apical ballooning in the absence of angiographically significant coronary artery stenosis. sympathetic activity dysfunction appears to play a very important role in the pathophysiology of takotsubo cardiomyopathy.

In most cases, myocardial scintillography with 123Imetaiodobenzylguanidine (MIBG) showed altered captation of the radiotracer in several heart segments. In particular, the apical myocardium has poor sympathetic innervations and an uptake reduction in MIBG tracer.

A hypothesis for this finding could be that the intense discharge of adrenalin, acting on heart segment with different and abnormal innervation, may produce a transient heart failure characterized by a particular shape of the left ventricle.

While studies have shown that heterogeneous MIBG distribution, decreased MIBG uptake and increased norepinephrine content were completely prevented by α-lipoic acid or by L-acetyl carnitine administrations in diabetic cardiomyopathy, no studies have examined the effects of these therapies on tako-tsubo cardiomyopathy.

On this basis, the investigators study will evaluate whether the dysfunction of adrenergic cardiac innervation, evaluated by MIBG, persist after previous experience of transient stress-induced cardiac dysfunction. Moreover, the investigators will assess whether the medications that restore sympatho-vagal alterations in diabetic cardiomyopathy, such as α-lipoic acid and L-acetyl carnitine, will improve the adrenergic cardiac innervation, in patients with SC.

Conditions

  • Apical Ballooning Syndrome
  • Nervous System Diseases, Sympathetic

Interventions

DRUG

Placebo

a placebo tablet bis in die for 12 months

DRUG

alpha-lipoic acid

alpha-lipoic, tablets of acid 400 mg bis in die (800 mg/day), for 12 months

DRUG

L-acetyl carnitine

L-acetyl carnitine tablets, 500 mg bis in die (1000 mg/day), for 12 months

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Principal Investigators

  • Raffaele Marfella, MD, PhD · University of Campania Luigi Vanvitelli

  • Raffaele Marfella, MD, PhD · Dept Geriatric and Metabolic diseases SUN, Naples, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-12-31
Completion
2016-01-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01524861 on ClinicalTrials.gov