Connective Tissue DiseasesEARLY-MYO-CTDNCT04297371
Early Detection of Cardiac Impairment and Prediction of RV Hypertrophy in Patients With CTD
An observational study of Connective Tissue Diseases and Right Ventricular Hypertrophy, run by RenJi Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Connective Tissue Diseases, Right Ventricular Hypertrophy
- What is being tested?
- CMR examination
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
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- Absence of known systemic diseases
- Normal examinations
- Age between 18-80 years old.
- Providing written informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Detection of Cardiac Impairment and Prediction of Right Ventricular Hypertrophy in Patients With Connective Tissue Disease
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.
Read the 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 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.
- Being tested
- CMR examination
- Keywords
- Connective Tissue Diseases, Extracellular Volume, Myocardial Deformation, Cardiovascular Magnetic Resonance
- Medical subject headings
- Connective Tissue Diseases, Hypertrophy, Right Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMR examinationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Diagnostic Test: CMR examination | |
| Control group | The controls were healthy volunteers who have normal electrocardiographic and echocardiographic results and normal CMR findings Receives: Diagnostic Test: CMR examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of cardiac condition
Compose of ventricular mass (g), volume (mL), ejection fraction (%) and strain (%) of both left and right ventricles.
Measured: 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 (%).
Measured: within 2 days of CMR scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study startJul 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Connective Tissue DiseasesStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng Jiang, MD, Study chair, RenJi Hospital, School of Medicine, Shanghai Jiantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297371
- Sponsor's protocol ID
- 2018-12-24R
- Acronym
- EARLY-MYO-CTD
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Cardiac Impairment and Prediction of Right Ventricular Hypertrophy in Patients With Connective Tissue Disease
- ClinicalTrials.gov ID
- NCT04297371
- Acronym / sponsor ID
- EARLY-MYO-CTD / 2018-12-24R
- Keywords
- Connective Tissue Diseases, Extracellular Volume, Myocardial Deformation, Cardiovascular Magnetic Resonance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CTD with RVH | – | Diagnostic Test: CMR examinationThe 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. |
| CTD without RVH | – | Diagnostic Test: CMR examinationThe 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). |
| Control group | – | Diagnostic Test: CMR examinationThe controls were healthy volunteers who have normal electrocardiographic and echocardiographic results and normal CMR findings |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMR examinationAfter 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. | Diagnostic test | CTD with RVH, CTD without RVH, Control group |
Primary outcome
Composite endpoint of cardiac condition
Time frame: within 2 days of CMR scan
Compose of ventricular mass (g), volume (mL), ejection fraction (%) and strain (%) of both left and right ventricles.
Composite endpoint of quantitative fibrosis assessment
Time frame: within 2 days of CMR scan
Compose of percentage of extracellular volume (%) and positive rate of late gadolinium enhancement (%).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng Jiang, MD study chair
RenJi Hospital, School of Medicine, Shanghai Jiantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Connective Tissue Diseases and Right Ventricular Hypertrophy, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of cardiac condition (time frame: within 2 days of CMR scan). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.