Insights in the Pathophysiology of Transient Left Ventricular Ballooning Syndrome (TLVBS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University Hospital, Gasthuisberg.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT01076946
First received: February 25, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

Transient left ventricular ballooning syndrome (TLVBS) is a cardiac syndrome that is characterised by acute but transient left ventricular (LV) dysfunction.

Since the syndrome clearly is not a rare phenomenon and since prognosis is not as benign as originally thought, there is a need for further research into the etiology and pathophysiology of TLVBS. Therefore the investigators aim to study the microvascular and endothelial function in their population of TLVBS patients.


Condition
Transient Left Ventricular Ballooning Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Insights in the Pathophysiology of Transient Left Ventricular Ballooning Syndrome (TLVBS)

Resource links provided by NLM:


Further study details as provided by University Hospital, Gasthuisberg:

Biospecimen Retention:   Samples Without DNA

plasma


Estimated Enrollment: 30
Study Start Date: March 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
TLVBS
patients with transient left ventricular ballooning

Detailed Description:

It was shown recently that in patients with previous TLVBS a cold pressor test (CPT) was able to induce new mid-ventricular and apical wall motion abnormalities, similar to those in the acute phase of the syndrome. Moreover, coronary blood flow (CBF), assessed by means of myocardial contrast echocardiography (MCE), increased in a group of control subjects but not in the TLVBS patients, suggesting a chronic impairment of coronary vasodilation reserve and thus microvascular dysfunction.

Since the syndrome clearly is not a rare phenomenon and since prognosis is not as benign as originally thought, there is a need for further research into the etiology and pathophysiology of TLVBS. Therefore the investigators aim to study the microvascular and endothelial function in their population of TLVBS patients. The project will be split up into two parts:

  1. From the patients that are already known in the prospective registry, patients willing to participate after informed consent will be asked to undergo a "reactive hyperaemia - pulse amplitude tonometry" (RH-PAT) baseline and after CPT and a cardiac magnetic resonance scan (CMR), at least 3 months after the last TLVBS event.

    The RH-PAT evaluates endothelial function. The CMR-evaluation at rest consists of assessment of global and regional left ventricular function, the exclusion of irreversible damage (lack of gadolinium hyperenhancement) and the evaluation of rest perfusion. Subsequently, adenosine-induced hyperemia is induced by an infusion of 140 µg/kg/min adenosine for 3 to 4 minutes, with stress perfusion sequence starting at 3 minutes. After approximately 10 minutes, a CPT will be performed (180 seconds immersion of the left foot in ice water (4°C)) immediately followed by a series of CMR cine sequences and a second stress perfusion CMR sequence. Afterwards the RH-PAT examination is repeated and blood sampling will be done for measuring plasma levels of B-type natriuretic peptide (BNP), the catecholamines epinephrine, norepinephrine, and dopamine and a marker for endothelial function endothelin-1.

    Patients will be monitored for one hour and before discharge two-dimensional (2D) echocardiography will be performed to exclude residual wall motion abnormalities. The investigators goal is to include at least 30 patients in this protocol.

  2. Patients who are newly admitted with TLVBS will follow a clinical path during index hospitalisation including serial ECG recording, serial blood sampling of cardiac biomarkers (Troponin I, CKMB), a sole sampling of BNP, catecholamines and endothelin-1, a RH-PAT measurement, a 2D echocardiogram, a coronary angiogram and a CMR with rest perfusion sequence. They will also be asked to return to the hospital at 3 months for the evaluation mentioned above. Patients will be added to the prospective registry.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients that were or will be admitted with TLVBS

Criteria

Inclusion Criteria:

  • For filling criteria of TLVBS
  • Presence of acute or subacute cardiac symptoms or events - Presence of reversible balloon-like left ventricular (LV) wall motion abnormalities (WMAs) that extend beyond the vascular distribution of a single epicardial vessel
  • Absence of ≥ 50% luminal narrowing or acute plaque rupture or intracoronary thrombus in the left anterior descending artery (LAD) in case the LAD extends well beyond the LV apex
  • Absence of pheochromocytoma, myocarditis, recent cardiac events or procedures, and recent stroke or head injury
  • Signed informed consent

Exclusion Criteria:

  • Not complying with any or more of the inclusion criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076946

Contacts
Contact: Peter Kayaert, MD +32 (0)16 34 09 26 peter.kayaert@uzleuven.be
Contact: Walter Desmet, MD, PhD +32 (0) 16 34 34 84 walter.desmet@uzleuven.be

Locations
Belgium
UZ Leuven Not yet recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Peter Kayaert, MD    +32 (0) 16 34 09 26    peter.kayaert@uzleuven.be   
Contact: Walter Desmet, MD PhD    +32 (0) 16 34 34 84    walter.desmet@uzleuven.be   
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
Principal Investigator: Peter Kayaert, MD UZ Leuven
  More Information

No publications provided

Responsible Party: UZ Leuven, Department Interventional Cardiology
ClinicalTrials.gov Identifier: NCT01076946     History of Changes
Other Study ID Numbers: pathophysiology TLVBS
Study First Received: February 25, 2010
Last Updated: February 25, 2010
Health Authority: Belgium: ethics committee UZ Leuven

Keywords provided by University Hospital, Gasthuisberg:
ballooning
TLVBS

Additional relevant MeSH terms:
Takotsubo Cardiomyopathy
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014