Asian neTwork for Translational Research and Cardiovascular Trials ("ATTRaCT")

April 4, 2024 updated by: National Heart Centre Singapore
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Heart failure (HF) is the final common pathway of cardiovascular (CV) diseases and leading cause of CV hospitalizations in Singapore and worldwide, with a mortality rate that rivals most cancers (>50% mortality at 5 years). Also similar to cancer, HF is a staged disease where early detection and treatment are vital for prevention of disease progression from Stage A (risk factors) to Stage B (subclinical structural heart disease) and Stage C (symptomatic HF). Cardiac imaging is critical for the detection of early subclinical disease. There is limited understanding of the mechanisms underlying disease progression and effective therapies are limited, particularly for the half of the HF population with preserved ejection fraction (HFPEF or "diastolic HF") for which there is no effective therapy to date (in contrast to HF with reduced ejection fraction [HFREF] or "systolic HF").

The investigators overall aim is 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.

Study Type

Observational

Enrollment (Actual)

815

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169609
        • National Heart Centre Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

  1. Age 21-99
  2. 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

Exclusion Criteria:

  1. HF primary due to severe valve disease
  2. 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)
  3. End stage renal failure (eGFR < 15ml/min/m2) or is receiving or planned to receive renal replacement therapy.
  4. Other specific subgroups of HF (Including constrictive pericarditis, complex adult congenital heart disease, hypertrophic cardiomyopathy, eosinophilic myocarditis, cardiac amyloid and acute chemotherapy-induces cardiomyopathy)
  5. Isolated right heart failure** (combined right and left heart failure will be included). (Secondary to severe lung disease or pulmonary hypertension)
  6. Life threatening co-morbidity with a life expectancy of < 1 year
  7. Inability to provide informed consent
  8. The patient is unable to comply with study protocol requirements
  9. The patient is participating in another clinical research trial(only if that study precludes involvement in an observational study)
  10. The patient has declined to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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.
Other: Electrocardiogram (ECG)
ECG is a non-invasive test used to detect any underlying heart conditions by measuring the electrical activity of the heart.
Other: Blood Sample Collection
Blood will be drawn for circulating biomarkers, which are measurable indicators of the severity or presence of the heart failure condition.
Other: Clinical Assessment
Check health status, blood pressure, heart rate, height and weight measured. In addition, subject will undergo a heart examination.
Other: Cardiovascular Ultrasound (CVUS)
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 [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)
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.
Other: Electrocardiogram (ECG)
ECG is a non-invasive test used to detect any underlying heart conditions by measuring the electrical activity of the heart.
Other: Blood Sample Collection
Blood will be drawn for circulating biomarkers, which are measurable indicators of the severity or presence of the heart failure condition.
Other: Clinical Assessment
Check health status, blood pressure, heart rate, height and weight measured. In addition, subject will undergo a heart examination.
Other: Cardiovascular Ultrasound (CVUS)
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 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)
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.
Other: Electrocardiogram (ECG)
ECG is a non-invasive test used to detect any underlying heart conditions by measuring the electrical activity of the heart.
Other: Blood Sample Collection
Blood will be drawn for circulating biomarkers, which are measurable indicators of the severity or presence of the heart failure condition.
Other: Clinical Assessment
Check health status, blood pressure, heart rate, height and weight measured. In addition, subject will undergo a heart examination.
Other: Cardiovascular Ultrasound (CVUS)
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.
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)
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.
Other: Electrocardiogram (ECG)
ECG is a non-invasive test used to detect any underlying heart conditions by measuring the electrical activity of the heart.
Other: Blood Sample Collection
Blood will be drawn for circulating biomarkers, which are measurable indicators of the severity or presence of the heart failure condition.
Other: Clinical Assessment
Check health status, blood pressure, heart rate, height and weight measured. In addition, subject will undergo a heart examination.
Other: Cardiovascular Ultrasound (CVUS)
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.
Other: Cognitive Test
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
First occurrence of cardiovascular event.
Time Frame: 3 Year
3 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart Centre Singapore

Collaborators

National University Hospital, Singapore
Khoo Teck Puat Hospital
Singapore General Hospital
Tan Tock Seng Hospital
Changi General Hospital

Investigators

  • Principal Investigator: Carolyn Lam, MBBS, National Heart Centre Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

May 30, 2016

First Submitted That Met QC Criteria

June 2, 2016

First Posted (Estimated)

June 6, 2016

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/2194

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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