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

NCT ID: NCT03689426

Last Updated: 2018-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-30

Study Completion Date

2021-04-30

Brief Summary

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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

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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

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Heart Failure Diffuse Fibrosis Focal Fibrosis Arrythmia

Keywords

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Cardiovascular Magnetic Resonance Imaging Tissue Characterisation Wearable Technology Prognosis Response to Therapy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age ≥18
* First hospital admission with a diagnosis of HF (as defined below)
* Able and willing to provide informed consent
* Able to undergo CMR

Exclusion Criteria

* Known or subsequent diagnosis of amyloidosis, sarcoidosis or hypertrophic cardiomyopathy
* Severe valve disease of any type requiring inpatient surgery
* Heart transplant recipient or admitted for cardiac transplantation/ left ventricular assist device
* Clinically apparent myocardial ischemia which requires revascularisation
* Myocardial infarction or revascularisation within the previous 60 days
* Intra cardiac mass which requires surgery
* Active endocarditis
* Septicaemia
* Pregnancy
* Life expectancy \<2 years secondary to any other cause (i.e. malignancy)
* Active treatment with chemotherapy
* Severe renal failure (GFR \<30)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Southampton

Southampton, Hampshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Andrew Flett, MBBS MD(Res) MRCP BSc(Hons)

Role: CONTACT

Phone: 02381205906

Email: [email protected]

Robert Adam, MBBS MRCP BSc(Hons)

Role: CONTACT

Phone: 02380777222

Email: [email protected]

Facility Contacts

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Andrew Flett, MBBS MD(Res) MRCP BSc(Hons)

Role: primary

Robert Adam, MBBS MRCP BSc(Hons)

Role: backup

Other Identifiers

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CAR0540

Identifier Type: -

Identifier Source: org_study_id