Therapy withdrawal in REcovered DCM – TRED

Phase 1

• Conditions: Dilated Cardiomyopathy with recovered cardiac function; MedDRA version: 20.0Level: PTClassification code 10007636Term: CardiomyopathySystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-005351-27-GB
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-19
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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 <250ng/ml.

(1) Maceira et al. Normalized left ventricular systolic and diastolic function by steady state free precession cardiovascular magnetic resonance. JCMR 2006;8:417-426.
(2) The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified