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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Hampshire
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Southampton, Hampshire, Reino Unido, SO166YD
- Reclutamiento
- University Hospital Southampton
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Contacto:
- Andrew Flett, MBBS MD(Res) MRCP BSc(Hons)
- Número de teléfono: 02381205906
- Correo electrónico: andrew.flett@uhs.nhs.uk
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Contacto:
- Robert Adam, MBBS MRCP BSc(Hons)
- Número de teléfono: 6744 02380777222
- Correo electrónico: robert.adam@uhs.nhs.uk
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Investigador principal:
- Andrew Flett, MBBS MD(Res) MRCP BSc(Hons)
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Sub-Investigador:
- Robert Adam, MBBS MRCP BSc(Hons)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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All Cause Mortality
Periodo de tiempo: 2 years
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Number of deaths within the study population
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2 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rehospitalisation with heart failure
Periodo de tiempo: 2 years
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Number of Rehospitalisations with heart failure within the study population
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2 years
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cardiac arrythmia
Periodo de tiempo: 30 days
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The number of any cardiac arrhythmia following discharge within the study population
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30 days
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CAR0540
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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