Ignite Creation Date:
2024-05-06 @ 2:22 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04297371
Status:
COMPLETED
Last Update Posted:
2020-08-13
First Post:
2020-03-02
Brief Title:
Early Detection of Cardiac Impairment and Prediction of RV Hypertrophy in Patients With CTD
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
Early Detection of Cardiac Impairment and Prediction of Right Ventricular Hypertrophy in Patients With Connective Tissue Disease
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EARLY-MYO-CTD
Brief Summary:
There have been reports suggesting that progressive RV failure and death in connective tissue disease CTD are related to right ventricular hypertrophy RVH and dilation irrespective of pulmonary arterial hypertension PAH The investigators aim to identify cardiac markers that occur before RVH and to investigate predictors of RVH
Detailed Description:
Patients with connective tissue disease CTD frequently exhibit multi-organ pathophysiological and functional damage The heart one of the leading causes of CTD mortality has attracted increasing attention However most patients with CTD present with nonspecific cardiac symptoms normal ECG and preserved left ventricular ejection fraction LVEF and therefore do not receive an early cardiac diagnosis Pulmonary arterial hypertension PAH right ventricular RV dilatation and hypertrophy are the first and the most frequent cardiac findings However these are late-stage phenomena which can eventually lead to death or right heart failure in CTDRight ventricle abnormalities is associated with the risk of heart failure and cardiovascular death RV dilation has long been considered a direct consequence of pulmonary arterial hypertension PAH but recently physicians have observed RVH in CTD patients as well RV dilation and RVH are not necessarily found in the same patient The pathophysiology behind these issues is less well-understood RVH progression continues even as CTD-associated PAH alleviates This finding implies PAH might not be the sole index that leads to RVH It would be interesting to explore factors that can predict the presence of RVH which may reduce major adversecardiovascular events in patients with CTD
Cardiovascular magnetic resonance CMR is able to depict myocardial characteristics from structure to tissue properties using cine and late gadolinium enhancement LGE sequences Newly developed imaging studies to date include T1 mapping and T1-derived Manuscript ECV estimationAll the previous studies in CTD have been restricted to patients with advanced cardiac involvement Together with clinical assessment and multi-imaging tests the aim of the present study was to find markers to detect cardiac involvement before RVH presented which could be important for guiding treatment decisions such as the timing and choice of pharmaceutical treatment The combination of myocardial functional and tissue changes may offer further insight into the pathophysiology of CTD
Cardiovascular magnetic resonance CMR is able to depict myocardial characteristics from structure to tissue properties using cine and late gadolinium enhancement LGE sequences Newly developed imaging studies to date include T1 mapping and T1-derived Manuscript ECV estimationAll the previous studies in CTD have been restricted to patients with advanced cardiac involvement Together with clinical assessment and multi-imaging tests the aim of the present study was to find markers to detect cardiac involvement before RVH presented which could be important for guiding treatment decisions such as the timing and choice of pharmaceutical treatment The combination of myocardial functional and tissue changes may offer further insight into the pathophysiology of CTD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None