Early Detection of Cardiac Impairment and Prediction of RV Hypertrophy in Patients With CTD

Phase

N/A

Condition

Connective Tissue Diseases

Musculoskeletal Diseases

Treatment

N/A

Clinical Study ID

NCT04297371

2018-12-24R

Ages 18-80
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria for CTD with RVH

Age between 18-80 years old.
Definite connective tissue diseases diagnosis.
Echocardiography demonstration (later confirmed by CMR) of a hypertrophic RV whenmaximal end-diastole RV wall thickness >4 mm due to CTD Inclusion Criteria for CTD without RVH
Age between 18-80 years old.
Definite connective tissue diseases diagnosis.
Echocardiography demonstration (later confirmed by CMR) that maximal end-diastole RVwall thickness ≤4 mm Inclusion Criteria for Control group:
Absence of known systemic diseases
Normal examinations
Age between 18-80 years old.
Providing written informed consent

Exclusion

Exclusion Criteria:

Age <18 years old or >80 years old
Documented coronary artery disease or prior angiography for coronary artery disease (>50% stenosis).
Patients with known congenital heart disease or other systemic diseases that mightinduce RVH.
Patients with standard metallic contraindications to CMR or an estimated glomerularfiltration rate < 30 ml/min/1.73 m2.

Study Design

July 01, 2014

November 30, 2016

Study 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 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.

Connect with a study center

Renji Hospital
Shanghai, Shanghai 200127
China
Site Not Available

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