A Randomised Trial Examining Therapy to Maintain Remission in Dilated Cardiomyopathy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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,

• New York Heart Association (NYHA) class I,

• sinus rhythm,

• taking a beta-blocker and an angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or sacubitril-valsartan, along with either a mineralocorticoid receptor antagonist (MRA) and/or sodium glucose co-transporter 2 inhibitor (SGLT2i).

Locations
Other Locations
United Kingdom
Royal Brompton Hospital
RECRUITING
London
Contact Information
Primary
Saad Javed, MBChB
tred2trial@imperial.ac.uk
02073528121
Time Frame
Start Date: 2023-12-02
Estimated Completion Date: 2026-09-15
Participants
Target number of participants: 50
Treatments
Experimental: Withdrawal of treatment with eplerenone or spironolactone, and empagliflozin and dapalgiflozin
Gradual, supervised withdrawal of ineralocorticoid receptor antagonists (spironolactone or eplerenone) and sodium glucose cotransporter 2 inhibitor (dapagliflozin or empagliflozin) over 4-16 weeks. Continued monitoring off study therapies during the cross-over phase.
No_intervention: Continued treatment with eplerenone or spironolactone, and empagliflozin and dapagliflozin
Continuation of usually prescribed pharmacological therapy over 16 weeks followed by cross-over to withdrawal of SGLT2i and MRA over the subsequent 4-16 weeks.
Sponsors
Collaborators: Royal Brompton & Harefield NHS Foundation Trust
Leads: Imperial College London

This content was sourced from clinicaltrials.gov