Insights in the Pathophysiology of Transient Left Ventricular Ballooning Syndrome (TLVBS)
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|ClinicalTrials.gov Identifier: NCT01076946|
Recruitment Status : Unknown
Verified December 2009 by University Hospital, Gasthuisberg.
Recruitment status was: Not yet recruiting
First Posted : February 26, 2010
Last Update Posted : February 26, 2010
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 or disease|
|Transient Left Ventricular Ballooning Syndrome|
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 :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Insights in the Pathophysiology of Transient Left Ventricular Ballooning Syndrome (TLVBS)|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||September 2010|
|Estimated Study Completion Date :||December 2010|
patients with transient left ventricular ballooning
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076946
|Contact: Peter Kayaert, MD||+32 (0)16 34 09 email@example.com|
|Contact: Walter Desmet, MD, PhD||+32 (0) 16 34 34 firstname.lastname@example.org|
|UZ Leuven||Not yet recruiting|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Contact: Peter Kayaert, MD +32 (0) 16 34 09 26 email@example.com|
|Contact: Walter Desmet, MD PhD +32 (0) 16 34 34 84 firstname.lastname@example.org|
|Principal Investigator:||Peter Kayaert, MD||UZ Leuven|