Health TrialsbyHealthPanel

Therapy to Maintain Remission in Dilated Cardiomyopathy

ConditionsHeart FailureCardiomyopathy, DilatedCardiomyopathiesHeart Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorImperial College London

About this trial

One third of patients diagnosed with heart failure demonstrate left ventricular reverse remodelling and recovery of cardiac function following a period of medical therapy. The TRED-HF trial investigated the impact of therapy withdrawal in this cohort and found that 40% of patients relapsed within 6 months of stopping treatment. In this follow-on study, the investigators will investigate the safety of therapy withdrawal of sodium cotransporter 2 inhibitors (SGLT2i) and mineralocorticord receptor anatagonists (MRAs) in patients with a previous diagnosis of heart failure and recovered cardiac function, in a randomised controlled trial to assess whether this maintains remission in this population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

a diagnosis of dilated cardiomyopathy,

previous left ventricular ejection fraction (LVEF) <40% (on echocardiography or cardiovascular magnetic resonance [CMR]),

current LVEF >50% with normal left ventricular end-diastolic volume (LVEDV),

plasma NT-pro-BNP<250ng/L,

Disqualifiers

Atrial fibrillation,

prior sustained ventricular tachycardia or fibrillation,

a known likely pathogenic or pathogenic variant in LMNA/DSP/FLNC/RBM20,

sudden cardiac or heart failure death in a first degree relative <50 years,

Trial design

Design model

Crossover

Treatments tested in this trial

  • Other

    Drug

    Withdrawal of mineralocorticoid receptor antagonists and/or sodium glucose cotransporter 2 inhibitors

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Withdrawal of treatment with eplerenone or spironolactone, and empagliflozin and dapalgiflozinExperimental treatment 1 intervention
Group B: Continued treatment with eplerenone or spironolactone, and empagliflozin and dapagliflozinNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Heart Failure Relapse assessed through left ventricular ejection fraction (LVEF)

Relapse of DCM defined by a reduction in LVEF\>10% and to below 50%

Time frame
32 weeks
2

Heart Failure Relapse assessed through pro-BNP

Relapse of DCM defined by a two-fold rise in NT-pro-BNP and to \>400ng/L

Time frame
32 weeks
3

Number of patients with heart failure Relapse assessed through signs of heart failure

Relapse of DCM defined by clinical signs of heart failure as determined by the research team

Time frame
32 weeks
4

Number of patients with heart failure Relapse assessed through symptoms of heart failure

Relapse of DCM defined by clinical symptoms of heart failure as determined by the research team

Time frame
32 weeks

Secondary outcomes

1

Left ventricular ejection fraction (LVEF)

Change in LVEF between baseline, during randomised phase (0-16 weeks) and follow-on phase (16-32 weeks)

Time frame
32 weeks
2

Left Ventricular End-Diastolic Volume Index indexed to body surface area (ml/m2) (LVEDVi)

Change in LVEDVi between baseline, during randomised phase (0-16 weeks) and follow-on phase (16-32 weeks)

Time frame
32 weeks
3

left ventricular global longitudinal strain (LV GLS)

Change in LV GLS between baseline, during randomised phase (0-16 weeks) and follow-on phase (16-32 weeks)

Time frame
32 weeks
4

left ventricular mass index (LVMi; g/m2)

Change in LVMI between baseline, during randomised phase (0-16 weeks) and follow-on phase (16-32 weeks)

Time frame
32 weeks

Other outcomes

Sponsors and contacts

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Imperial College London

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov
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