Heart failure & cardiomyopathiesRandomised controlled trial
Continuous Risk Monitoring and Management of Heart Failure: Rationale and Design of the ALLEVIATE-HF Trial
- Randomised controlled trial (rationale and design)
- prospective
- double-blind
- multicentre
After 13 months of randomized follow-up, all patients enter an unblinded prolonged follow-up phase with PRN interventions upon high risk
Authors' conclusion
ALLEVIATE-HF will evaluate how ICM-based HF management can impact the outcomes of patients with HF regardless of ejection fraction.
Study context
- Population
- NYHA class II or III heart failure (HF) with recent HF hospitalization, outpatient IV diuretics or elevated natriuretic peptides, without an implanted cardiac device or haemodynamic monitorplanned enrolment
- Participants
- ~760 participants
- Comparison
- Insertable cardiac monitor (ICM)-guided intervention pathway vs observation
- Primary endpoint
- Hierarchical composite of CV death, HF events, KCCQ score and 6-min walk test distance
- Follow-up
- 13 months of randomized
Original publication
Continuous Risk Monitoring and Management of Heart Failure: Rationale and Design of the ALLEVIATE-HF Trial. Eur J Heart Fail. Published 27 January 2025. doi:10.1002/ejhf.3595
Summarised from the published abstract; every number is checked against it