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UNKNOWNNA

Therapy to Maintain Remission in Dilated Cardiomyopathy

Sponsor: Imperial College London

NCT ID: NCT06091475

View on ClinicalTrials.gov ↗

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.

Heart FailureCardiomyopathy, DilatedCardiomyopathiesHeart Diseases

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What we know so far

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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

eGFR

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
Inclusion Criteria: 1. a diagnosis of dilated cardiomyopathy, 2. previous left ventricular ejection fraction (LVEF) \<40% (on echocardiography or cardiovascular magnetic resonance \[CMR\]), 3. current LVEF \>50% with normal left ventricular end-diastolic volume (LVEDV), 4. plasma NT-pro-BNP\<250ng/L, 5. New York Heart Association (NYHA) class I, 6. sinus rhythm, 7. 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). Exclusion Criteria: 1. Atrial fibrillation, 2. prior sustained ventricular tachycardia or fibrillation, 3. a known likely pathogenic or pathogenic variant in LMNA/DSP/FLNC/RBM20, 4. sudden cardiac or heart failure death in a first degree relative \<50 years, 5. contraindication to CMR, 6. estimated glomerular filtration rate (eGFR) \<60mls/min, 7. planned pregnancy,8) active myocardial inflammation, 9\) diabetes mellitus managed with an SGLT2i, 10) urinary albumin-to-creatine ratio of 200-5000 (mg:g) and eGFR\< 75mls/min.

Where Is This Study? (1 UK site)

Royal Brompton Hospital

London, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Saad Javed, MBChB

Sponsor contact

CONTACT

02073528121 tred2trial@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-09