NCT02791009

Brief Summary

To build on Singapore's competitive advantages in advanced cardiac imaging, genetic and molecular studies to develop an integrated "one -stop" platform spanning from human to large and small animal models, dedicated to deepening the understanding of CV disease progression, discovery of new targets and repurposing of drugs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
815

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

April 5, 2024

Status Verified

August 1, 2023

Enrollment Period

5.7 years

First QC Date

May 30, 2016

Last Update Submit

April 4, 2024

Conditions

Keywords

HFHFrEFHFpEFMRIbiomarker

Outcome Measures

Primary Outcomes (1)

  • First occurrence of cardiovascular event.

    3 Year

Study Arms (4)

Diagnosed Heart Failure [Prior]

Patients will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imaging (CMRI), Cardiovascular Ultrasound (CVUS), Electrocardiogram (ECG), Blood Sample Collection and Clinical Assessment.

Other: Cardiovascular Magnetic Resonance Imaging (CMRI)Other: Electrocardiogram (ECG)Other: Blood Sample CollectionOther: Clinical AssessmentOther: Cardiovascular Ultrasound (CVUS)

Control [Prior]

Control will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imaging (CMRI), Cardiovascular Ultrasound (CVUS), Electrocardiogram (ECG), Blood Sample Collection and Clinical Assessment.

Other: Cardiovascular Magnetic Resonance Imaging (CMRI)Other: Electrocardiogram (ECG)Other: Blood Sample CollectionOther: Clinical AssessmentOther: Cardiovascular Ultrasound (CVUS)

Control [New]

Control will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imaging (CMRI), Cardiovascular Ultrasound (CVUS), Electrocardiogram (ECG), Blood Sample Collection and Clinical Assessment.

Other: Cardiovascular Magnetic Resonance Imaging (CMRI)Other: Electrocardiogram (ECG)Other: Blood Sample CollectionOther: Clinical AssessmentOther: Cardiovascular Ultrasound (CVUS)

Diagnosed Heart Failure [New]

Patients will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imaging (CMRI), Cardiovascular Ultrasound (CVUS), Electrocardiogram (ECG), Blood Sample Collection, Cognitive Test and Clinical Assessment.

Other: Cardiovascular Magnetic Resonance Imaging (CMRI)Other: Electrocardiogram (ECG)Other: Blood Sample CollectionOther: Clinical AssessmentOther: Cardiovascular Ultrasound (CVUS)Other: Cognitive Test

Interventions

CMRI uses interaction of the magnetic properties of body tissues with strong magnetic fields to create images; for about 1 hour. Several sets of images are needed. No injection of drug or dye will be used for this procedure.

Control [New]Control [Prior]Diagnosed Heart Failure [New]Diagnosed Heart Failure [Prior]

ECG is a non-invasive test used to detect any underlying heart conditions by measuring the electrical activity of the heart.

Control [New]Control [Prior]Diagnosed Heart Failure [New]Diagnosed Heart Failure [Prior]

Blood will be drawn for circulating biomarkers, which are measurable indicators of the severity or presence of the heart failure condition.

Control [New]Control [Prior]Diagnosed Heart Failure [New]Diagnosed Heart Failure [Prior]

Check health status, blood pressure, heart rate, height and weight measured. In addition, subject will undergo a heart examination.

Control [New]Control [Prior]Diagnosed Heart Failure [New]Diagnosed Heart Failure [Prior]

To measure heart chamber size, heart function, blood vessel size and blood vessel function. These measurements will help the investigators understand the type and severity of heart failure.

Control [New]Control [Prior]Diagnosed Heart Failure [New]Diagnosed Heart Failure [Prior]

To relate the presence and severity of cognitive impairment (CI) with simultaneously acquired advanced cardiovascular imaging characteristics and circulating biomarkers of cardiovascular function, inflammation and coagulation.

Diagnosed Heart Failure [New]

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

800 diagnosed heart failure patient will be recruited from primary care clinic, outpatient clinics and hospital ward from Singapore (NUHCS, NHCS, TTSH, CGH, KTPH, SGH). 800 healthy volunteer control.

You may qualify if:

  • Age 21-99
  • Present to hospital with diagnosis of HF, or
  • Attending a hospital clinic for management of HF within 6/12 of an episode of decompensated heart failure\* which either:
  • Resulted in a hospital admission (primary diagnosis) or
  • Was treated in out-patient clinic \* Appropriate symptoms and signs of HF, confirmed by PI when necessary

You may not qualify if:

  • HF primary due to severe valve disease
  • The primary diagnosis is an Acute coronary syndrome (ACS) which has resulted in a transient episode of Acute pulmonary oedema (APO) (Note: Patients with a troponin rise noted during the index admission, but in whom the main presentation is considered clinically to the HF will be included)
  • End stage renal failure (eGFR \< 15ml/min/m2) or is receiving or planned to receive renal replacement therapy.
  • Other specific subgroups of HF (Including constrictive pericarditis, complex adult congenital heart disease, hypertrophic cardiomyopathy, eosinophilic myocarditis, cardiac amyloid and acute chemotherapy-induces cardiomyopathy)
  • Isolated right heart failure\*\* (combined right and left heart failure will be included). (Secondary to severe lung disease or pulmonary hypertension)
  • Life threatening co-morbidity with a life expectancy of \< 1 year
  • Inability to provide informed consent
  • The patient is unable to comply with study protocol requirements
  • The patient is participating in another clinical research trial(only if that study precludes involvement in an observational study)
  • The patient has declined to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

Biospecimen

Retention: SAMPLES WITH DNA

Specific biomarker profiles

MeSH Terms

Conditions

Heart Failure

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Carolyn Lam, MBBS

    National Heart Centre Singapore

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 6, 2016

Study Start

August 1, 2015

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

April 5, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations