Using Cardiovascular Magnetic Resonance Tissue Characterisation and Wearable Technology to PREDICT Clinical Outcomes, Response to Therapy and Arrhythmias in Hospitalised Heart Failure Patients (PREDICT-HF)
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|ClinicalTrials.gov Identifier: NCT03689426|
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
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.
|Condition or disease|
|Heart Failure Diffuse Fibrosis Focal Fibrosis Arrythmia|
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.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Using Cardiovascular Magnetic Resonance Tissue Characterisation and Wearable Technology to Predict Clinical Outcomes, Response to Therapy and Arrhythmias in Hospitalised Heart Failure Patients|
|Actual Study Start Date :||April 30, 2018|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||April 30, 2021|
- All Cause Mortality [ Time Frame: 2 years ]Number of deaths within the study population
- Rehospitalisation with heart failure [ Time Frame: 2 years ]Number of Rehospitalisations with heart failure within the study population
- Cardiac arrythmia [ Time Frame: 30 days ]The number of any cardiac arrhythmia following discharge within the study population
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689426
|Contact: Andrew Flett, MBBS MD(Res) MRCP BSc(Hons)||email@example.com|
|Contact: Robert Adam, MBBS MRCP BSc(Hons)||02380777222 ext firstname.lastname@example.org|
|University Hospital Southampton||Recruiting|
|Southampton, Hampshire, United Kingdom, SO166YD|
|Contact: Andrew Flett, MBBS MD(Res) MRCP BSc(Hons) 02381205906 email@example.com|
|Contact: Robert Adam, MBBS MRCP BSc(Hons) 02380777222 ext 6744 firstname.lastname@example.org|
|Principal Investigator: Andrew Flett, MBBS MD(Res) MRCP BSc(Hons)|
|Sub-Investigator: Robert Adam, MBBS MRCP BSc(Hons)|