Heart FailurePREDICT-HFNCT03689426
Using Cardiovascular Magnetic Resonance Tissue Characterisation and Wearable Technology to PREDICT Clinical Outcomes, Response to Therapy and Arrhythmias in Hospitalised Heart Failure Patients
An observational study of Heart Failure and Diffuse Fibrosis, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Diffuse Fibrosis, Focal Fibrosis
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2018to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age ≥18
- First hospital admission with a diagnosis of HF (as defined below)
- Able and willing to provide informed consent
- Able to undergo CMR
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Southampton
Southampton, Hampshire, SO166YD
Andrew Flett, MBBS MD(Res) MRCP BSc(Hons), 02381205906, andrew.flett@uhs.nhs.uk
Robert Adam, MBBS MRCP BSc(Hons), 02380777222 ext. 6744, robert.adam@uhs.nhs.uk
About this study
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
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.
Read the 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
- Keywords
- Cardiovascular Magnetic Resonance Imaging, Tissue Characterisation, Wearable Technology, Prognosis, Response to Therapy
- Medical subject headings
- Heart Failure, Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cause Mortality
Number of deaths within the study population
Measured: 2 years
Secondary outcomes (1)
Rehospitalisation with heart failure
Number of Rehospitalisations with heart failure within the study population
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start30 Apr 2018
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689426
- Sponsor's protocol ID
- CAR0540
- Acronym
- PREDICT-HF
- Status last verified
- Sep 2018
- First submitted
- 27 Sep 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03689426
- Acronym / sponsor ID
- PREDICT-HF / CAR0540
- Conditions
- Heart Failure, Diffuse Fibrosis, Focal Fibrosis, Arrythmia
- Keywords
- Cardiovascular Magnetic Resonance Imaging, Tissue Characterisation, Wearable Technology, Prognosis, Response to Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age ≥18
- First hospital admission with a diagnosis of HF (as defined below)
- Able and willing to provide informed consent
- Able to undergo CMR
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All Cause Mortality
Time frame: 2 years
Number of deaths within the study population
1 secondary outcome
Rehospitalisation with heart failure
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Diffuse Fibrosis, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Flett, MBBS MD(Res) MRCP BSc(Hons) (02381205906, andrew.flett@uhs.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All Cause Mortality (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.