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New treatment option for Heart Failure With Reduced Ejection Fraction
Official title Withdrawal of Treatment for Heart Failure Patients With Recovery From Tachycardia-induced Cardiomyopathy
ClinicalTrials.gov ID: NCT06128980
What this study is testing
What is GDMT?
GDMT is an investigational medicine, being studied as a potential treatment for heart failure with reduced ejection fraction.
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
- New onset heart failure (HF) is observed in up to 25% of patients with incident atrial fibrillation or flutter (AF). Current guidelines suggest that both conditions (AF \& HF) be addressed with guideline directed medical therapy (GDMT) for HF and rate or rhythm control of AF.
- Phase 3: a large, late-stage study
- 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 and older
You may be able to join if
- Patients with new onset heart failure (ambulatory or hospital) with reduced ejection fraction (LVEF≤40% assessed by echocardiography) and NYHA ≥2 and...
You likely can't join if
- 18 years or older and able to consent
- Former ablation procedures and inability to tolerate antiarrhythmic drugs
- Pregnancy
- Congenital heart disease (congenital defects with no hemodyamic effects are not excluded)
- Previously genotyped positive for genes known to cause cardiomyopathy
- Probable hypertrophic, restrictive or non-compaction cardiomyopathy
See the full eligibility criteria
- Patients with new onset heart failure (ambulatory or hospital) with reduced ejection fraction (LVEF≤40% assessed by echocardiography) and NYHA ≥2 and atrial fibrillation or atrial flutter with ventricular rate ≥110 bpm...
- 18 years or older and able to consent
- Former ablation procedures and inability to tolerate antiarrhythmic drugs
- Pregnancy
- Congenital heart disease (congenital defects with no hemodyamic effects are not excluded)
- Previously genotyped positive for genes known to cause cardiomyopathy
- Probable hypertrophic, restrictive or non-compaction cardiomyopathy
- Moderate/severe valvular disease
- Suspicion of or known cardiac amyloidosis, sarcoidosis, or other storage/inflammatory disease
- More than 10% PVCs or documented sustained ventricular arrhythmias
- History of persistent or permanent AF with ventricular rates \>110 before incident HF despite best standard of care
- eGFR \< 30 ml/min/1.73 m2
- Acute myocardial infarction at index
- Probable medication-, alcohol- or illicit drug use induced AF and/or HF
- Systolic blood pressure \>160 mmHg (at multiple measurements) at index or history of uncontrollable hypertension
- Myocarditis
- Cardiogenic shock at index
- Aborted sudden cardiac death
- Pacing-induced cardiomyopathy
- 1.st degree relative with DCM
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. 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.