A Novel Automated & Comprehensive Approach for Ventricular Function Assessment in Heart Failure

NCT02791126 | Completed

• 1 other identifier: 2013/934/C
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure is a major health care burden. It can occur with either normal or reduced LV ejection fraction, depending on different degrees of ventricular remodelling. The investigators recently published a new method, curvedness-based imaging. The investigators have also reported the diagnostic utility of curvedness-based imaging in various cardiac diseases. The investigators now propose to prospectively assess curvedness-based imaging for diagnosis of heart failure with normal ejection fraction and with reduced ejection fraction, and examine left ventricular systolic and diastolic function and predicts the prognosis in a cohort of HF patients.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Allergic reaction due to MRI contrast

  Within first day of scan

Study Arms (1)

Heart Failure

Patients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic. Cardiovascular Magnetic Resonance and Echocardiogram will be performed.

Other: Cardiovascular Magnetic Resonance; Other: Echocardiogram

Interventions

Cardiovascular Magnetic Resonance OTHER

For the evaluation of left ventricular volumes, function and mass. This is also for the assessment of myocardial fibrosis based on delayed enhancement imaging technique.

Heart Failure

Echocardiogram OTHER

For the assessment of diastolic and systolic function as well as valvular and cardiac function. Ventricular-arterial coupling will also be performed.

Heart Failure

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic

You may qualify if:

• Patients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic.
• Written informed consent obtained

You may not qualify if:

• Aged \< 21 years
• Contraindication to CMR examination.
• Cardiac pacemaker
• Brain aneurysm or clips
• Electronic implants or prosthesis
• Eye metal foreign body injury
• Severe claustrophobia
• Severe renal impairment, glomerular filtration rate \< 30ml/min/1.73m2
• Non-cardiac illness with life expectancy of less than 2 years
• Previous heart, kidney, liver or lung transplantation.
• HF primary due to severe valve disease
• Other specific subgroups of HF: Including constrictive pericarditis, complex adult congenital heart disease, hypertrophic cardiomyopathy, eosinophilic myocarditis, cardiac amyloid and acute chemotherapy-induced cardiomyopathy.
• Isolated right heart failure. Combined right and left heart failure will be included; Secondary to severe lung disease or pulmonary hypertension.

Sponsors & Collaborators

• National Heart Centre Singapore: lead

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Ru San Tan, MD

  National Heart Centre Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 6, 2016
• Study Start: November 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 5, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)