An observational study in Connective Tissue Diseases and Right Ventricular Hypertrophy, sponsored by RenJi Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-13.
Sponsored by RenJi Hospital · Observational
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.
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 CTD.Right 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 estimation.All 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.
150 studies on the registry are indexed under Connective Tissue Diseases; 60 are open to participants now.
This study's enrollment of 136 is below the median of 250 across 49 observational studies indexed under Connective Tissue Diseases.
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Consecutive subjects were prospectively enrolled into 3 cohorts between July 2014 and Nov 2016. The cohorts were divided as follows: the CTD patients with RVH, the CTD patients without RVH and the control group.
Inclusion Criteria for CTD with RVH
Inclusion Criteria for CTD without RVH
Inclusion Criteria for Control group:
Exclusion Criteria:
The diagnosis of CTD was made based on the clinical classification criteria. The RVH patient was diagnosed by an echocardiography demonstration (later confirmed by CMR) of a hypertrophic RV (maximal end-diastole RV wall thickness \>4 mm) due to CTD.
Diagnostic Test: CMR examination
The diagnosis of CTD was made based on the clinical classification criteria.The subjects were enrolled as having non-RVH if their RV wall thickness was ≤ 4 mm (later confirmed by CMR).
Diagnostic Test: CMR examination
The controls were healthy volunteers who have normal electrocardiographic and echocardiographic results and normal CMR findings
Diagnostic Test: CMR examination
After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment.
Composite endpoint of cardiac condition
Compose of ventricular mass (g), volume (mL), ejection fraction (%) and strain (%) of both left and right ventricles.
Time frame: within 2 days of CMR scan
Composite endpoint of quantitative fibrosis assessment
Compose of percentage of extracellular volume (%) and positive rate of late gadolinium enhancement (%).
Time frame: within 2 days of CMR scan
Plan to share: No
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Hypertrophy, Right Ventricular
RenJi Hospital