Therapy withdrawal in REcovered DCM – TRED

A randomised controlled pilot trial of the feasibility and safety of therapy withdrawal in asymptomatic patients with a prior diagnosis of dilated cardiomyopathy & recovered cardiac function. - Therapy withdrawal in REcovered Dilated cardiomyopathy trial (TRED)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005351-27-GB

Enrollment

Registered

2016-01-19

Start date

2016-02-17

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dilated Cardiomyopathy with recovered cardiac function MedDRA version: 20.0 Level: PT Classification code 10007636 Term: Cardiomyopathy System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: PT Classification code 10007636 Term: Cardiomyopathy System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: High-Ceiling Diuretics Product Name: High-Ceiling Diuretics Product Code: C03C Pharmaceutical Form: Tablet INN or Proposed INN: Furosemide Concentration unit: mg milligram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of DCM confirmed by 2 independent operators based on clinical details and previous imaging. 2. Currently taking at least 1 of the following medications: loop diuretic, beta blocker, Angiotensin Converting Enzyme (ACE) inhibitor, Angiotensin Receptor Blocker (ARB) and Mineralocorticoid Receptor antagonist (MRA). 3. Evidence of Left Ventricular Reverse Remodelling (LVRR) following the initial diagnosis with subsequent improvement in ejection fraction from =40% to =50% and normalisation of LV volumes on CMR (1) (or echocardiography if a contraindication to CMR exists). 4. Without symptoms of heart failure (NYHA Class 1) (2). 5. Plasma NTproBNP =65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: 1. Uncontrolled hypertension (clinic blood pressure >160/100mmHg) 2. Age < 16 years 3. More than moderate valvular disease 4. Estimated glomerular filtration rate <30mls/min 5. Atrial/supraventricular/ventricular arrhythmia requiring beta-blockade. 6. Pregnancy 7. Angina.

Design outcomes

Primary

Measure	Time frame
Main Objective: We aim to determine whether it is feasible and safe to withdraw heart failure therapies from patients with a previous diagnosis of DCM who now have recovered cardiac function and no symptoms of heart failure. It is unclear from current research whether it is safe and feasible to do so and current practice varies between doctors. Despite this being a commonly encountered scenario in clinical practice, current national and international guidelines do not make recommendations on the management of these patients. We will determine whether it is appropriate to design and conduct a larger study investigating the effect of withdrawing therapy in this group on medium- and long-term mortality and morbidity. If this pilot study shows that many patients with DCM can be weaned from therapy without a relapse in the appearance of DCM then it will be appropriate to design a large, simple outcome study investigating the long-term consequences for morbidity and mortality. If the rate of relapse an;Secondary Objective: We aim to investigate the factors which predict sustained recovery or relapse following withdrawal of medical therapy. These factors will include baseline demographics and clinical characteristics, CMR imaging findings, serum biomarkers and genetic characteristics.;Primary end point(s): The primary endpoint will be the ability to withdraw heart failure medication without a relapse of DCM within 6 months (defined as one of the following: a reduction in LVEF >10% and to below 50%, increase in LV volumes by >10% or two-fold rise in baseline NT-pro-BNP level and to >400ng/ml).;Timepoint(s) of evaluation of this end point: The composite primary end-point will be under continuous evaluation by the research team and analysed at 6 months.	—

Measure

Time frame

Main Objective: We aim to determine whether it is feasible and safe to withdraw heart failure therapies from patients with a previous diagnosis of DCM who now have recovered cardiac function and no symptoms of heart failure. It is unclear from current research whether it is safe and feasible to do so and current practice varies between doctors. Despite this being a commonly encountered scenario in clinical practice, current national and international guidelines do not make recommendations on the management of these patients. We will determine whether it is appropriate to design and conduct a larger study investigating the effect of withdrawing therapy in this group on medium- and long-term mortality and morbidity. If this pilot study shows that many patients with DCM can be weaned from therapy without a relapse in the appearance of DCM then it will be appropriate to design a large, simple outcome study investigating the long-term consequences for morbidity and mortality. If the rate of relapse an;Secondary Objective: We aim to investigate the factors which predict sustained recovery or relapse following withdrawal of medical therapy. These factors will include baseline demographics and clinical characteristics, CMR imaging findings, serum biomarkers and genetic characteristics.;Primary end point(s): The primary endpoint will be the ability to withdraw heart failure medication without a relapse of DCM within 6 months (defined as one of the following: a reduction in LVEF >10% and to below 50%, increase in LV volumes by >10% or two-fold rise in baseline NT-pro-BNP level and to >400ng/ml).;Timepoint(s) of evaluation of this end point: The composite primary end-point will be under continuous evaluation by the research team and analysed at 6 months.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints will be included to gain pilot data into possible effect sizes for the powering of the follow-on randomised-control trial. These will include a functional assessment using CPET testing, a quality of life assessment using the KCCQ, a composite patient safety end-point of CV mortality, major adverse cardiovascular events or unplanned CV hospitalisation, an arrhythmia end-point of new sustained supraventricular or ventricular arrhythmias, further imaging end-points of increase left atrial volume by >10% or new or increase in myocardial scar detected by CMR and a biomarker end-point assessing the number of patients with a two-fold rise in NT-pro-BNP and to >400 ng/ml. ;Timepoint(s) of evaluation of this end point: The secondary end-points will be under continuous evaluation by the research team and analysed at 6 months.	—

Measure

Time frame

Secondary end point(s): Secondary endpoints will be included to gain pilot data into possible effect sizes for the powering of the follow-on randomised-control trial. These will include a functional assessment using CPET testing, a quality of life assessment using the KCCQ, a composite patient safety end-point of CV mortality, major adverse cardiovascular events or unplanned CV hospitalisation, an arrhythmia end-point of new sustained supraventricular or ventricular arrhythmias, further imaging end-points of increase left atrial volume by >10% or new or increase in myocardial scar detected by CMR and a biomarker end-point assessing the number of patients with a two-fold rise in NT-pro-BNP and to >400 ng/ml. ;Timepoint(s) of evaluation of this end point: The secondary end-points will be under continuous evaluation by the research team and analysed at 6 months.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026