Clinical trial NCT02791009: Asian neTwork for Translational Research and Cardiovascular Trials ("ATTRaCT")
Official title: Asian neTwork for Translational Research and Cardiovascular Trials ("ATTRaCT")
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: HF
HFrEF
HFpEF
MRI
biomarker
Lead sponsor: National Heart Centre Singapore
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
name: National University Hospital, Singapore
name: Tan Tock Seng Hospital
name: Khoo Teck Puat Hospital
name: Changi General Hospital
First posted: 2016-06-06
Enrollment: 815
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: First occurrence of cardiovascular event.
timeFrame: 3 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
Study officials:
affiliation: National Heart Centre Singapore
name: Carolyn Lam, MBBS
role: PRINCIPAL_INVESTIGATOR
References: