Reverse Remodelling and Remission Markers in the Serial Evaluation of Recent-onset Dilated Cardiomyopathy (REMIT-DCM)
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|ClinicalTrials.gov Identifier: NCT04957147|
Recruitment Status : Recruiting
First Posted : July 12, 2021
Last Update Posted : July 12, 2021
Approximately 30-40% of patients with non-ischaemic dilated cardiomyopathy (DCM) undergo significant left ventricular reverse remodelling in response to guideline-directed therapies. This is characterised by improvement in systolic dysfunction and regression of left ventricular dilatation. In some patients, extensive left ventricular reverse remodelling is accompanied by resolution of symptoms and normalisation of cardiac biomarkers, resulting in a state of clinical remission.
The mechanistic drivers behind left ventricular reverse remodelling and clinical remission are poorly understood. Current techniques to predict ventricular remodelling trajectory and clinical remission in patients with recent-onset DCM are limited.
The purpose of this study is to characterise predictors and markers of left ventricular reverse remodelling and clinical remission in patients with recent-onset DCM using molecular markers, genetics and advanced CMR imaging.
|Condition or disease||Intervention/treatment|
|Dilated Cardiomyopathy||Other: 12 months of guideline-directed heart failure therapy|
The REMIT-DCM study is a single-centre pilot observational cohort study. 70 patients with recent-onset DCM (Group A) and up to 40 healthy volunteers (Group B) will be recruited. Patients with DCM will be recruited over a 2-year period and will be followed up for 12 months. Subjects in Group A may be offered an optional further study visit at 24-48 months after enrolment in order to assess whether cardiac remodelling and clinical remission are sustained over the intermediate-term.
Patients with DCM (Group A) will attend 3 study visits at The Royal Brompton Hospital (baseline, 2-3 months and 12 months). Each study visit will involve a clinical consultation, blood sample collection (including routine clinical blood tests and sample storage for exploratory biomarkers), urine sample collection, 12-lead ECG, health questionnaire completion and a cardiovascular magnetic resonance scan (CMR). If patients are unable to have a CMR, 3D transthoracic echocardiography will be performed.
Healthy volunteers will attend a single study visit at The Royal Brompton Hospital. This will involve a clinical consultation, blood sample collection (including routine clinical blood tests and sample storage for exploratory biomarkers), urine sample collection, 12-lead ECG, health questionnaire completion and a CMR.
|Study Type :||Observational|
|Estimated Enrollment :||110 participants|
|Official Title:||The REMIT-DCM Study: Reverse Remodelling and Remission Markers in the Serial Evaluation of Recent-onset Dilated Cardiomyopathy|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||September 28, 2022|
|Estimated Study Completion Date :||September 28, 2022|
Group A: patients with dilated cardiomyopathy
Patients with recent-onset dilated cardiomyopathy
Other: 12 months of guideline-directed heart failure therapy
Standard guideline-directed heart failure drug +/- device therapy
Group B: healthy volunteers
Healthy volunteers with no known heart disease
- Clinical remission [ Time Frame: 12-months ]
If all 3 of the following criteria are met at 12-month assessment:
i. Increase in left ventricular ejection fraction (LVEF) by ≥ 10% to a value ≥ 50% and decrease in indexed left ventricular end diastolic volume (LVEDV) to within normal range according to age-/sex-corrected normograms.
ii. NYHA class I.
iii. NT-Pro BNP <250 ng/L.
- Left ventricular reverse remodelling [ Time Frame: 12-months ]Evaluated by changes in indexed left ventricular end systolic volume (LVESV), indexed LVEDV and LVEF between baseline and 12 months.
- Left ventricular reverse remodelling [ Time Frame: 12-months ]
Evaluated using a pre-specified threshold: patients with DCM will be divided into 2 groups at the 12-month timepoint:
i. Left ventricular reverse remodelling: an increase in LVEF by ≥ 10% to a value ≥ 40%; and a decrease in indexed LVEDV by ≥ 10%.
ii. No left ventricular reverse remodelling: no increase in LVEF by ≥ 10% to a value ≥ 40% and/or no decrease in indexed LVEDV by ≥ 10%.
- Major adverse cardiovascular events [ Time Frame: 12-months ]Composite of cardiovascular death, major heart failure or major arrhythmic events.
- Change in health status using Kansas City Cardiomyopathy questionnaire [ Time Frame: 12-months ]Change in Kansas City Cardiomyopathy questionnaire scores from baseline to 12-months
- Change in health status using SF-12 questionnaire [ Time Frame: 12-months ]Change in SF-12 questionnaire scores from baseline to 12-months
- Change in health status using EQ-5D questionnaire [ Time Frame: 12-months ]Change in EQ-5D questionnaire scores from baseline to 12-months
- Sustained clinical remission at 24-48 months after enrolment [ Time Frame: 48 months ]For those in clinical remission at 12-month timepoint, the proportion that have sustained clinical remission at 24-48 months after enrolment.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04957147
|Contact: Daniel J Hammersley, MBBS||020 7352 8121 ext email@example.com|
|London, United Kingdom, SW3 6LY|
|Contact: Daniel J Hammersley, MBBS 020 7352 8121 ext 88814 firstname.lastname@example.org|
|Principal Investigator:||Sanjay K Prasad||Imperial College London|