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New treatment option for Heart Failure
Official title Therapy to Maintain Remission in Dilated Cardiomyopathy
ClinicalTrials.gov ID: NCT06091475
What this study is testing
What is Other?
Other is an investigational medicine, being studied as a potential treatment for heart failure.
Also referred to as Withdrawal of spironolactone or eplerenone and dapagliflozin or empagliflozin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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,
You likely can't join if
- Atrial fibrillation,
- prior sustained ventricular tachycardia or fibrillation,
- a known likely pathogenic or pathogenic variant in LMNA/DSP/FLNC/RBM20,
- sudden cardiac or heart failure death in a first degree relative \<50 years,
- contraindication to CMR,
- estimated glomerular filtration rate (eGFR) \<60mls/min,
See the full eligibility criteria
- 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...
- Atrial fibrillation,
- prior sustained ventricular tachycardia or fibrillation,
- a known likely pathogenic or pathogenic variant in LMNA/DSP/FLNC/RBM20,
- sudden cardiac or heart failure death in a first degree relative \<50 years,
- contraindication to CMR,
- estimated glomerular filtration rate (eGFR) \<60mls/min,
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.