- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03689426
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)
Using Cardiovascular Magnetic Resonance Tissue Characterisation and Wearable Technology to Predict Clinical Outcomes, Response to Therapy and Arrhythmias in Hospitalised Heart Failure Patients
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Andrew Flett, MBBS MD(Res) MRCP BSc(Hons)
- Phone Number: 02381205906
- Email: andrew.flett@uhs.nhs.uk
Study Contact Backup
- Name: Robert Adam, MBBS MRCP BSc(Hons)
- Phone Number: 6744 02380777222
- Email: robert.adam@uhs.nhs.uk
Study Locations
-
-
Hampshire
-
Southampton, Hampshire, United Kingdom, SO166YD
- Recruiting
- University Hospital Southampton
-
Contact:
- Andrew Flett, MBBS MD(Res) MRCP BSc(Hons)
- Phone Number: 02381205906
- Email: andrew.flett@uhs.nhs.uk
-
Contact:
- Robert Adam, MBBS MRCP BSc(Hons)
- Phone Number: 6744 02380777222
- Email: robert.adam@uhs.nhs.uk
-
Principal Investigator:
- Andrew Flett, MBBS MD(Res) MRCP BSc(Hons)
-
Sub-Investigator:
- Robert Adam, MBBS MRCP BSc(Hons)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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:
Signs and symptoms of heart failure
&
- 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.
Description
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All Cause Mortality
Time Frame: 2 years
|
Number of deaths within the study population
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rehospitalisation with heart failure
Time Frame: 2 years
|
Number of Rehospitalisations with heart failure within the study population
|
2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac arrythmia
Time Frame: 30 days
|
The number of any cardiac arrhythmia following discharge within the study population
|
30 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAR0540
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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