NCT03689426

Using Cardiovascular Magnetic Resonance Tissue Characterisation and Wearable Technology to PREDICT Clinical Outcomes, Response to Therapy and Arrhythmias in Hospitalised Heart Failure Patients

Using Cardiovascular Magnetic Resonance Tissue Characterisation and Wearable Technology to Predict Clinical Outcomes, Response to Therapy and Arrhythmias in Hospitalised Heart Failure Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University Hospital Southampton NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

150 patients admitted to University Hospital Southampton with heart failure will undergo comprehensive Cardiovascular Magnetic Resonance (CMR) imagining during their admission and continuous heart rhythm monitoring using wearable technology post discharge. We hypothesise that analysis of this outcome data will discover novel CMR tissue characterisation and heart rhythm biomarkers that can be used to predict adverse clinical outcomes in heart failure populations and how individual patients will respond to specific therapies.

Detailed description

PREDICT-HF a low risk single centre observational study in which 150 consecutive patients admitted with a new, primary diagnosis of heart failure undergo advanced CMR to non-invasively establish their individual myocardial tissue characteristics during their initial presentation. All study participants will be invited to participate in an optional heart rhythm and rate monitoring sub study which will involve continuous electrocardiographic monitoring for up to 2 days prior to discharge and up to 30 day immediately post discharge using a Samsung S-PATCH device. To enable multivariate statistical analysis to be performed each study participant will undergo a range of validated investigation to comprehensively establish and monitor other recognised heart failure prognostic biomarkers. Participants will be managed per current NICE heart failure guidelines and will undergo rigorous clinical reviews at 6, 12 and 24 months. All clinically relevant event data e.g. MACE, rehospitalisation, decompensation and arrhythmias will be meticulously recorded for each participant throughout the study period. This study will identify novel CMR derived tissue characterisation biomarkers of adverse outcome, response to therapy and arrhythmias in a hospitalised heart failure population. It will also be the first study to utilise wearable heart monitoring technology to accurately record heart rate and rhythm data in this population and investigate the potential impact of this on patient's clinical management and outcomes.

Conditions

• Heart Failure
• Diffuse Fibrosis
• Focal Fibrosis
• Arrythmia

Timeline

• Start date: 2018-04-30
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2018-09-28
• Last updated: 2018-09-28

Locations

1 site across 1 country: United Kingdom