NCT03689426

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

3 years

First QC Date

September 27, 2018

Last Update Submit

September 27, 2018

Conditions

Heart FailureDiffuse FibrosisFocal FibrosisArrythmia

Keywords

Cardiovascular Magnetic Resonance ImagingTissue CharacterisationWearable TechnologyPrognosisResponse to Therapy

Outcome Measures

Primary Outcomes (1)

  • All Cause Mortality

    Number of deaths within the study population

    2 years

Secondary Outcomes (1)

  • Rehospitalisation with heart failure

    2 years

Other Outcomes (1)

  • Cardiac arrythmia

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Age ≥18
  • First hospital admission with a diagnosis of HF (as defined below)
  • Able and willing to provide informed consent
  • Able to undergo CMR

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Southampton

Southampton, Hampshire, SO166YD, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma and urine samples will be stored for future 'OMICS' analysis.

MeSH Terms

Conditions

Heart FailureArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Andrew Flett, MBBS MD(Res) MRCP BSc(Hons)

CONTACT

02381205906andrew.flett@uhs.nhs.uk

Robert Adam, MBBS MRCP BSc(Hons)

CONTACT

02380777222robert.adam@uhs.nhs.uk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2018

First Posted

September 28, 2018

Study Start

April 30, 2018

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

September 28, 2018

Record last verified: 2018-09

Locations

GB(1)