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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 (PREDICT-HF)

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ClinicalTrials.gov Identifier: NCT03689426
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Brief 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.


Condition or disease
Heart Failure Diffuse Fibrosis Focal Fibrosis Arrythmia

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. All Cause Mortality [ Time Frame: 2 years ]
    Number of deaths within the study population


Secondary Outcome Measures :
  1. Rehospitalisation with heart failure [ Time Frame: 2 years ]
    Number of Rehospitalisations with heart failure within the study population


Other Outcome Measures:
  1. Cardiac arrythmia [ Time Frame: 30 days ]
    The number of any cardiac arrhythmia following discharge within the study population


Biospecimen Retention:   Samples With DNA
Whole blood, plasma and urine samples will be stored for future 'OMICS' analysis.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

All patients admitted to University Hospital Southampton with a new primary diagnosis of heart failure will be considered for the study.

The diagnosis of heart failure will be confirmed by a senior cardiologist with a subspecialty interest in heart failure following detailed review of the patient's history, clinical findings and investigations using the following diagnostic criteria:

  1. Signs and symptoms of heart failure

    &

  2. Objective evidence of cardiac dysfunction either by;

Left ventricular ejection fraction of ≤ 50%

or;

Plasma concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP) >400 pg/mL if in sinus rhythm or > 1000 pg/ml if in atrial fibrillation/flutter and being treated with either oral or intravenous furosemide ≥40 mg/day or equivalent at the time of inclusion.

Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: Andrew Flett, MBBS MD(Res) MRCP BSc(Hons) 02381205906 andrew.flett@uhs.nhs.uk
Contact: Robert Adam, MBBS MRCP BSc(Hons) 02380777222 ext 6744 robert.adam@uhs.nhs.uk

Locations
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United Kingdom
University Hospital Southampton Recruiting
Southampton, Hampshire, United Kingdom, SO166YD
Contact: Andrew Flett, MBBS MD(Res) MRCP BSc(Hons)    02381205906    andrew.flett@uhs.nhs.uk   
Contact: Robert Adam, MBBS MRCP BSc(Hons)    02380777222 ext 6744    robert.adam@uhs.nhs.uk   
Principal Investigator: Andrew Flett, MBBS MD(Res) MRCP BSc(Hons)         
Sub-Investigator: Robert Adam, MBBS MRCP BSc(Hons)         
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
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Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03689426    
Other Study ID Numbers: CAR0540
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Southampton NHS Foundation Trust:
Cardiovascular Magnetic Resonance Imaging
Tissue Characterisation
Wearable Technology
Prognosis
Response to Therapy
Additional relevant MeSH terms:
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Heart Failure
Arrhythmias, Cardiac
Fibrosis
Heart Diseases
Cardiovascular Diseases
Pathologic Processes