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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791009
• Other study ID #: 2015/2194
• Status: Completed
• Start date: August 2015
• Est. completion date: March 31, 2021

Study information

• Verified date: August 2023
• Source: National Heart Centre Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 drugs.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 815
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Singapore	National Heart Centre Singapore	Singapore

Sponsors (6)

Lead Sponsor	Collaborator
National Heart Centre Singapore	Changi General Hospital, Khoo Teck Puat Hospital, National University Hospital, Singapore, Singapore General Hospital, Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First occurrence of cardiovascular event.		3 Year