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

NCT ID: NCT02791009

Last Updated: 2024-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

815 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Cardiovascular Magnetic Resonance Imaging (CMRI)

Intervention Type OTHER

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.

Electrocardiogram (ECG)

Intervention Type OTHER

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

Blood Sample Collection

Intervention Type OTHER

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

Clinical Assessment

Intervention Type OTHER

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

Cardiovascular Ultrasound (CVUS)

Intervention Type OTHER

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.

Cardiovascular Magnetic Resonance Imaging (CMRI)

Intervention Type OTHER

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.

Electrocardiogram (ECG)

Intervention Type OTHER

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

Blood Sample Collection

Intervention Type OTHER

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

Clinical Assessment

Intervention Type OTHER

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

Cardiovascular Ultrasound (CVUS)

Intervention Type OTHER

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.

Cardiovascular Magnetic Resonance Imaging (CMRI)

Intervention Type OTHER

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.

Electrocardiogram (ECG)

Intervention Type OTHER

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

Blood Sample Collection

Intervention Type OTHER

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

Clinical Assessment

Intervention Type OTHER

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

Cardiovascular Ultrasound (CVUS)

Intervention Type OTHER

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.

Cardiovascular Magnetic Resonance Imaging (CMRI)

Intervention Type OTHER

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.

Electrocardiogram (ECG)

Intervention Type OTHER

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

Blood Sample Collection

Intervention Type OTHER

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

Clinical Assessment

Intervention Type OTHER

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

Cardiovascular Ultrasound (CVUS)

Intervention Type OTHER

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.

Cognitive Test

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Electrocardiogram (ECG)

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

Intervention Type 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.

Intervention Type OTHER

Clinical Assessment

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

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role collaborator

Khoo Teck Puat Hospital

OTHER

Sponsor Role collaborator

Changi General Hospital

OTHER

Sponsor Role collaborator

National Heart Centre Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carolyn Lam, MBBS

Role: PRINCIPAL_INVESTIGATOR

National Heart Centre Singapore

Locations

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National Heart Centre Singapore

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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2015/2194

Identifier Type: -

Identifier Source: org_study_id

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