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

NCT04297371 | Completed DMC

• 1 other identifier: 2018-12-24R
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Connective Tissue Diseases; Right Ventricular Hypertrophy

Keywords

Connective Tissue Diseases; Extracellular Volume; Myocardial Deformation; Cardiovascular Magnetic Resonance

Outcome Measures

Primary Outcomes (2)

• Composite endpoint of cardiac condition

  Compose of ventricular mass (g), volume (mL), ejection fraction (%) and strain (%) of both left and right ventricles.

  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 (%).

  within 2 days of CMR scan

Study Arms (3)

CTD with RVH

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

CTD without RVH

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

Control group

The controls were healthy volunteers who have normal electrocardiographic and echocardiographic results and normal CMR findings

Diagnostic Test: CMR examination

Interventions

CMR examination DIAGNOSTIC_TEST

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.

CTD with RVH; CTD without RVH; Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Age between 18-80 years old.
• Definite connective tissue diseases diagnosis.
• Echocardiography demonstration (later confirmed by CMR) of a hypertrophic RV when maximal end-diastole RV wall thickness \>4 mm due to CTD
• Age between 18-80 years old.
• Definite connective tissue diseases diagnosis.
• Echocardiography demonstration (later confirmed by CMR) that maximal end-diastole RV wall thickness ≤4 mm
• Absence of known systemic diseases
• Normal examinations
• Age between 18-80 years old.
• Providing written informed consent

You may not qualify if:

• 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 might induce RVH.
• Patients with standard metallic contraindications to CMR or an estimated glomerular filtration rate \< 30 ml/min/1.73 m2.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Connective Tissue Diseases; Hypertrophy, Right Ventricular

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Meng Jiang, MD

  RenJi Hospital, School of Medicine, Shanghai Jiantong University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 5, 2020
• Study Start: July 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)