A randomised trial investigating therapies needed to maintain remission in dilated cardiomyopathy

Phase 4

• Conditions: Patients with a previous diagnosis of dilated cardiomyopathy who have improved cardiac function and who are asymptomatic; Circulatory System

• Registration Number: ISRCTN60045220
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-18
• Last Update Posted: 22 April 2024
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. A diagnosis of DCM
2. Previous LVEF <40% (on echocardiography or cardiovascular magnetic resonance [CMR])
3. Current LVEF >50% for at least 6 months duration with normal left ventricular end-diastolic volume (LVEDV) at inclusion
4. Plasma NT-pro-BNP<250ng/L
5. New York Heart Association (NYHA) class I
6. Sinus rhythm
7. Taking a beta-blocker and an ACEi, ARB or sacubitril-valsartan, along with at least one of an MRA or SGLT2i.

Exclusion Criteria

1. Current atrial fibrillation
2. Prior sustained ventricular tachycardia or fibrillation
3. A known likely pathogenic or pathogenic variant in LMNA/DSP/FLNC/RBM20
4. Sudden cardiac or heart failure death in a first degree relative <50 years
5. Contraindication to CMR
6. Estimated glomerular filtration rate (eGFR) <45mls/min
7. Current or planned pregnancy
8. Known active myocardial inflammation
9. Another indication for an SGLT2i (diabetes mellitus or CKD)
10. Previous relapse of symptomatic heart failure following initial recovery in function
11. Current participation in another CTIMP
12. Ongoing need for other heart failure therapies including loop diuretics, ivabradine or digoxin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse of DCM defined by any one of the following:<br>1. A reduction in LVEF>10% and to below 50%<br>2. A two-fold rise in NT-pro-BNP and to >400ng/L or<br>3. Clinical features of heart failure as determined by the research team.<br>This is a composite of prognostically important variables supported by the findings of TRED-HF, taking into account changes in markers of cardiac function and congestion. The primary analysis will take place after 16 weeks of the randomised phase. There will also be a follow-on phase. The incidence of the primary end-point will also be assessed between 16-32 weeks.

Secondary Outcome Measures

Name	Time	Method
At baseline, 16 weeks and 32 weeks:<br>1. Left ventricular ejection fraction (%) (cardiovascular magnetic resonance [CMR])<br>2. Left ventricular end-diastolic volume indexed to body surface area (ml/m²) (CMR)<br>3. Left ventricular global longitudinal strain (LV GLS) (CMR)<br>4. Left ventricular mass index (LVMi; g/m²) (CMR)<br>5. Left atrial volume index (LAVi; ml/m²) (CMR)<br>6. Left atrial strain (LAS) (CMR)<br>7. Right ventricular ejection fraction (RVEF; %) (CMR)<br>8. NT-pro-BNP (ng/L) (plasma concentration from peripheral blood sampling)<br>9. Quality of life: EQ-5D-5L score<br>10. Treatment Burden Questionnaire score