- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01076946
Insights in the Pathophysiology of Transient Left Ventricular Ballooning Syndrome (TLVBS)
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.
Study Overview
Status
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:
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.
- 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Peter Kayaert, MD
- Phone Number: +32 (0)16 34 09 26
- Email: peter.kayaert@uzleuven.be
Study Contact Backup
- Name: Walter Desmet, MD, PhD
- Phone Number: +32 (0) 16 34 34 84
- Email: walter.desmet@uzleuven.be
Study Locations
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- UZ Leuven
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Contact:
- Peter Kayaert, MD
- Phone Number: +32 (0) 16 34 09 26
- Email: peter.kayaert@uzleuven.be
-
Contact:
- Walter Desmet, MD PhD
- Phone Number: +32 (0) 16 34 34 84
- Email: walter.desmet@uzleuven.be
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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TLVBS
patients with transient left ventricular ballooning
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Collaborators and Investigators
Investigators
- Principal Investigator: Peter Kayaert, MD, UZ Leuven
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- pathophysiology TLVBS
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Clinical Trials on Transient Left Ventricular Ballooning Syndrome
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Mayo ClinicCompletedApical Ballooning SyndromeUnited States
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Mayo ClinicCompletedApical Ballooning SyndromeUnited States
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University of Campania "Luigi Vanvitelli"CompletedApical Ballooning Syndrome | Nervous System Diseases, SympatheticItaly
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Mayo ClinicUnited States Department of DefenseCompletedMyocardial Infarction | Coronary Endothelial Dysfunction | Apical Ballooning SyndromeUnited States
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Montreal Heart InstituteOttawa Heart Institute Research CorporationCompletedAcute Coronary Syndrome | Left Ventricular DysfunctionCanada
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University of LeipzigCompletedLeft Ventricular Hypertrophy | Left Ventricular Failure | Left Ventricular Non-compaction CardiomyopathyGermany
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Lawson Health Research InstituteMedtronicTerminatedHeart Failure, Left Ventricular DysfunctionCanada
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AstraZenecaCompletedLeft Ventricle FunctionSweden
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Assistance Publique Hopitaux De MarseilleCompletedLeft Ventricular Non CompactionFrance
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Lawson Health Research InstituteRecruiting