Heart FailureNCT02791009
Asian neTwork for Translational Research and Cardiovascular Trials ("ATTRaCT")
An observational study of Heart Failure, run by National Heart Centre Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiovascular Magnetic Resonance Imaging (CMRI), Electrocardiogram (ECG) and Blood Sample Collection
- Type of treatment
- Injection or infusion
- How many people
- 815 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2015to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Cardiovascular Magnetic Resonance Imaging (CMRI), Electrocardiogram (ECG), Blood Sample Collection, Clinical Assessment, Cardiovascular Ultrasound (CVUS)
- Keywords
- HF, HFrEF, HFpEF, MRI, biomarker
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Magnetic Resonance Imaging (CMRI)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)Other
ECG is a non-invasive test used to detect any underlying heart conditions by measuring the electrical activity of the heart.
Blood Sample CollectionOther
Blood will be drawn for circulating biomarkers, which are measurable indicators of the severity or presence of the heart failure condition.
Clinical AssessmentOther
Check health status, blood pressure, heart rate, height and weight measured. In addition, subject will undergo a heart examination.
Cardiovascular Ultrasound (CVUS)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 TestOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cardiovascular Magnetic Resonance Imaging (CMRI); Other: Electrocardiogram (ECG); Other: Blood Sample Collection; Other: Clinical Assessment; Other: 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. Receives: Other: Cardiovascular Magnetic Resonance Imaging (CMRI); Other: Electrocardiogram (ECG); Other: Blood Sample Collection; Other: Clinical Assessment; Other: 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. Receives: Other: Cardiovascular Magnetic Resonance Imaging (CMRI); Other: Electrocardiogram (ECG); Other: Blood Sample Collection; Other: Clinical Assessment; Other: 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. Receives: Other: Cardiovascular Magnetic Resonance Imaging (CMRI); Other: Electrocardiogram (ECG); Other: Blood Sample Collection; Other: Clinical Assessment; Other: Cardiovascular Ultrasound (CVUS); Other: Cognitive Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
First occurrence of cardiovascular event.
Measured: 3 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startAug 2015
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 815 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital, National University Hospital, Singapore, Tan Tock Seng Hospital, Khoo Teck Puat Hospital, Changi General Hospital
- Responsible party
- Sponsor
- Investigators
- Carolyn Lam, MBBS, Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791009
- Sponsor's protocol ID
- 2015/2194
- Status last verified
- Aug 2023
- First submitted
- 30 May 2016
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asian neTwork for Translational Research and Cardiovascular Trials ("ATTRaCT")
- ClinicalTrials.gov ID
- NCT02791009
- Acronym / sponsor ID
- 2015/2194
- Conditions
- Heart Failure
- Keywords
- HF, HFrEF, HFpEF, MRI, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 815 participants (actual)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Collaborators
- Singapore General Hospital, National University Hospital, Singapore, Tan Tock Seng Hospital, Khoo Teck Puat Hospital, Changi General Hospital
- Study start
- Aug 2015 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diagnosed Heart Failure [Prior] | – | Other: Cardiovascular Magnetic Resonance Imaging (CMRI), Other: Electrocardiogram (ECG), Other: Blood Sample Collection, Other: Clinical Assessment, Other: Cardiovascular Ultrasound (CVUS)Patients will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imaging (CMRI), Cardiovascular Ultrasound (CVUS), Electrocardiogram (ECG), Blood Sample Collection and Clinical Assessment. |
| Control [Prior] | – | Other: Cardiovascular Magnetic Resonance Imaging (CMRI), Other: Electrocardiogram (ECG), Other: Blood Sample Collection, Other: Clinical Assessment, Other: Cardiovascular Ultrasound (CVUS)Control will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imaging (CMRI), Cardiovascular Ultrasound (CVUS), Electrocardiogram (ECG), Blood Sample Collection and Clinical Assessment. |
| Control [New] | – | Other: Cardiovascular Magnetic Resonance Imaging (CMRI), Other: Electrocardiogram (ECG), Other: Blood Sample Collection, Other: Clinical Assessment, Other: Cardiovascular Ultrasound (CVUS)Control will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imaging (CMRI), Cardiovascular Ultrasound (CVUS), Electrocardiogram (ECG), Blood Sample Collection and Clinical Assessment. |
| Diagnosed Heart Failure [New] | – | Other: Cardiovascular Magnetic Resonance Imaging (CMRI), Other: Electrocardiogram (ECG), Other: Blood Sample Collection, Other: Clinical Assessment, Other: Cardiovascular Ultrasound (CVUS), Other: Cognitive TestPatients will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imaging (CMRI), Cardiovascular Ultrasound (CVUS), Electrocardiogram (ECG), Blood Sample Collection, Cognitive Test and Clinical Assessment. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Control [New], Control [Prior], Diagnosed Heart Failure [New], Diagnosed Heart Failure [Prior] |
| Electrocardiogram (ECG)ECG is a non-invasive test used to detect any underlying heart conditions by measuring the electrical activity of the heart. | Other | Control [New], Control [Prior], Diagnosed Heart Failure [New], Diagnosed Heart Failure [Prior] |
| Blood Sample CollectionBlood will be drawn for circulating biomarkers, which are measurable indicators of the severity or presence of the heart failure condition. | Other | Control [New], Control [Prior], Diagnosed Heart Failure [New], Diagnosed Heart Failure [Prior] |
| Clinical AssessmentCheck health status, blood pressure, heart rate, height and weight measured. In addition, subject will undergo a heart examination. | Other | Control [New], Control [Prior], Diagnosed Heart Failure [New], Diagnosed Heart Failure [Prior] |
| 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 | Control [New], Control [Prior], Diagnosed Heart Failure [New], Diagnosed Heart Failure [Prior] |
| Cognitive TestTo 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. | Other | Diagnosed Heart Failure [New] |
Primary outcome
First occurrence of cardiovascular event.
Time frame: 3 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn Lam, MBBS principal investigator
National Heart Centre Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by National Heart Centre Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First occurrence of cardiovascular event. (time frame: 3 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.