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

Heart Failure Clinical Trial

— PREDICT-HF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03689426
• Other study ID #: CAR0540
• Status: Recruiting
• Start date: April 30, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2018
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: Andrew Flett, MBBS MD(Res) MRCP BSc(Hons)
• Phone: 02381205906
• Email: andrew.flett[@]uhs.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arrythmia
• Diffuse Fibrosis
• Fibrosis
• Focal Fibrosis
• Heart Failure

Locations

Country	Name	City	State
United Kingdom	University Hospital Southampton	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiac arrythmia	The number of any cardiac arrhythmia following discharge within the study population	30 days
Primary	All Cause Mortality	Number of deaths within the study population	2 years
Secondary	Rehospitalisation with heart failure	Number of Rehospitalisations with heart failure within the study population	2 years