At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Other (drug)
- How long the study runs
- Study runs about 33 months (dates as stated)
- About the drug or intervention
- Other — drug: Withdrawal of mineralocorticoid receptor antagonists and/or sodium glucose cotransporter 2 inhibitors
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 85 Years
- Who
- All
- Number of participants
- 50
- Started
- 2023-12-02
- Last checked
- 2024-09
Plain English Summary
What is this study?
- • Testing a new treatment for heart failure
- • NA - 50 participants
- • One third of patients diagnosed with heart failure demonstrate left ventricular reverse remodelling and recovery of cardiac function following a period of medical therapy
Who can take part?
- • Ages 18 Years to 85 Years
- • Diagnosed with heart failure
Where?
- • London - Royal Brompton Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
One third of patients diagnosed with heart failure demonstrate left ventricular reverse remodelling and recovery of cardiac function following a period of medical therapy. These patients have an excellent long-term prognosis. Whether they need to remain on long-term medical therapy is not clear. Current guideline directed treatment of patients with heart failure relies on a combination of (1) angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs), (2) beta-blockers, (3) mineralocorticoid antagonists, and (4) sodium-glucose co-transporter 2 inhibitors (SGLT2i). The TRED-HF trial, confirmed that complete withdrawal of beta-blockers, ACEi or ARBs, and MRAs resulted in relapse within 6 months in 40% of asymptomatic patients with a previous diagnosis of DCM and improved cardiac function. This confirmed that many patients have heart failure remission rather than sustained recovery and still benefit from at least some pharmacological therapy. Defining the therapies required to maintain heart failure remission is a priority for heart failure research, taking into account the changing therapeutic needs of many millions of patients following improvement in their cardiac function. In this follow-on study to the TRED-HF trial, the investigators will carry out an open-label, randomised clinical trial examining the safety and feasibility of sequential mineralocorticoid receptor antagonist (MRA) and sodium glucose co-transporter 2 inhibitor (SGLT2i) withdrawal in 50 patients with dilated cardiomyopathy who are now in heart failure remission and taking angiotensin system inhibitors and beta-blockers. Patients will have serial cardiovascular magnetic resonance (CMR) scans and circulating biomarkers after withdrawal of each therapy and will be followed for 8 months. The primary end-point will be relapse of heart failure defined by features of adverse remodelling.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 85 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓a diagnosis of dilated cardiomyopathy,
- ✓previous left ventricular ejection fraction (LVEF) \<40% (on echocardiography or cardiovascular magnetic resonance...
- ✓current LVEF \>50% with normal left ventricular end-diastolic volume (LVEDV),
- ✓plasma NT-pro-BNP\<250ng/L,
- ✓New York Heart Association (NYHA) class I,
Who cannot take part
- ✗Atrial fibrillation,
- ✗prior sustained ventricular tachycardia or fibrillation,
- ✗a known likely pathogenic or pathogenic variant in LMNA/DSP/FLNC/RBM20,
- ✗sudden heart or heart failure death in a first degree relative \<50 years,
- ✗safety concern to CMR,
See the full criteria
Where Is This Study? (1 UK site)
Royal Brompton Hospital
London, United Kingdom
How to Get in Touch
Saad Javed, MBChB
Sponsor contactCONTACT
