Heart Failure Clinical Trial
— TEAM-HFOfficial title:
Prevalence of Cardiac Amyloidosis in Patients With Hospitalization for Acute Heart Failure in the French West Indies
NCT number | NCT05501847 |
Other study ID # | 20_RIPH2-23 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 27, 2023 |
Est. completion date | June 2024 |
Heart failure is defined as the inability of the heart to provide sufficient output to meet the needs of the body. It can occur in the course of a myocardial infarction, angina pectoris, hypertension, etc. Its frequency increases with age. It is a major public health problem. Heart failure first appears during exercise, then at rest. Initially, the heart tries to adapt to the loss of its contraction force by accelerating its beats (increase in heart rate), then it increases in volume (thickening of the walls or dilation of the cardiac cavities). This extra workload for the heart eventually leads to heart failure. Cardiac amyloidosis is a possible cause of the disease in the West Indian population. Cardiac amyloidosis is a rare disease related to our own proteins that will accumulate and cluster together to form abnormal protein deposits that will eventually lead to heart failure. Cardiac amyloidosis particularly affects West Indians, due to the high frequency in this population of a genetic anomaly associated with the disease: the Valine 122 Isoleucine (Val122l) mutation of the transthyretin gene (protein transthyretin in which isoleucine is substituted for valine at position 122 (Ile 122)). Early detection of amyloidosis appears essential for the implementation of appropriate therapies and therefore for an improvement in patient survival. For this it seems important to better specify the frequency of cardiac amyloidosis in heart failure in the French West Indies.
Status | Recruiting |
Enrollment | 446 |
Est. completion date | June 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - Present functional or physical signs of acute heart failure (exertional dyspnea, orthopnea, paroxysmal nocturnal dyspnea, fatigue, jugular turgor, hepato-jugular reflux, edema of the lower limbs, galloping noise, crackles on pulmonary auscultation) - BNP >100pg/mL or NT-proBNP >300pg/mL - Diagnosis of heart failure confirmed by the cardiologist - Be affiliated to a social security plan or beneficiary - Be able to receive and understand information related to the research - Able to freely express his/her non-opposition or informed and written consent. Exclusion Criteria: - Person under legal protection (guardianship, curatorship, safeguard of justice), and person deprived of liberty. |
Country | Name | City | State |
---|---|---|---|
Guadeloupe | Laurent LARIFLA | Pointe-à-Pitre | |
Martinique | CHU de Martinique | Fort-de-France |
Lead Sponsor | Collaborator |
---|---|
University Hospital Center of Martinique |
Guadeloupe, Martinique,
Arvanitis M, Chan GG, Jacobson DR, Berk JL, Connors LH, Ruberg FL. Prevalence of mutant ATTR cardiac amyloidosis in elderly African Americans with heart failure. Amyloid. 2017 Dec;24(4):253-255. doi: 10.1080/13506129.2017.1391086. Epub 2017 Oct 20. No abs — View Citation
Dungu JN, Papadopoulou SA, Wykes K, Mahmood I, Marshall J, Valencia O, Fontana M, Whelan CJ, Gillmore JD, Hawkins PN, Anderson LJ. Afro-Caribbean Heart Failure in the United Kingdom: Cause, Outcomes, and ATTR V122I Cardiac Amyloidosis. Circ Heart Fail. 20 — View Citation
Gabet A, Juilliere Y, Lamarche-Vadel A, Vernay M, Olie V. National trends in rate of patients hospitalized for heart failure and heart failure mortality in France, 2000-2012. Eur J Heart Fail. 2015 Jun;17(6):583-90. doi: 10.1002/ejhf.284. Epub 2015 May 6. — View Citation
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of cardiac amyloidosis in acute heart failure patients in the French West Indies | The prevalence of cardiac amyloidosis in acute heart failure patients in Martinique and Guadeloupe over the study period will be determined by the following ratio
Number of cardiac amyloidosis (old + new cases) in acute heart failure patients with hospital referral over the study period divided by the total number of acute heart failure patients with hospital referral over the period concerned This prevalence will be expressed per 10,000 and 100,000 people. |
18 months +/- 8 days post inclusion | |
Secondary | Patient demographic characteristics | Age, gender, ethnicity, locality | Baseline | |
Secondary | To compare the clinical characteristics of heart failure patients with cardiac amyloidosis to other causes of heart failure | New York Heart Association (NYHA) stage, Heart failure picture | Baseline | |
Secondary | To compare the biological (total bilirubin) characteristics of heart failure patients with cardiac amyloidosis to other causes of heart failure | Biological assessment heart failure (total bilirubin) expressed in mg/L | Baseline | |
Secondary | To compare the biological (BNP or NT-proBNP) characteristics of heart failure patients with cardiac amyloidosis to other causes of heart failure | Biological assessment heart failure (BNP or NT-proBNP) expressed in pg/mL | Baseline | |
Secondary | To compare the biological (thyroid stimulating hormone) characteristics of heart failure patients with cardiac amyloidosis to other causes of heart failure | Biological assessment heart failure (thyroid stimulating hormone) expressed in mUI/l | Baseline | |
Secondary | To compare the biological (High-sensitivity (hs) cardiac troponin (cTn)) characteristics of heart failure patients with cardiac amyloidosis to other causes of heart failure | Biological assessment heart failure (High-sensitivity (hs) cardiac troponin (cTn)) expressed in µg/L | Baseline | |
Secondary | To compare the genotypic characteristics of heart failure patients with cardiac amyloidosis to other causes of heart failure | Presence of a mutation in the transthyretin gene | Baseline or through visit T2, an average of 6 months | |
Secondary | Describe the cases of amyloidosis identified according to the severity of cardiac involvement | Extra-cardiac impact (renal and liver function) | Baseline | |
Secondary | Describe the cases of amyloidosis according to the severity of the heart failure | Biomarkers (brain natriuretic peptide (BNP) or N-terminal fragment of probrain natriuretic peptide (NT-proBNP), High-sensitivity (hs) cardiac troponin (cTn)), etc expressed in sub-units of grams / sub-units of liters | Baseline | |
Secondary | Ultrasound criteria predictive of amyloid with or no LVH =12 mm | Ultrasound criteria predictive of amyloid involvement according to the presence or absence of LVH =12 mm by detailed analysis of cardiac echography | Baseline or up to 24 weeks post inclusion | |
Secondary | Diagnostic score for cardiac amyloidosis in acute heart failure | This score will be composed of clinical, biological and imaging characteristics significantly associated with the presence of cardiac amyloidosis in a heart failure patient following the implementation of multivariate logistic regression modelling. The internal validation of this score will be determined by assessing :
The discrimination parameters of the score: sensitivity, specificity, and area under the Receiver Operating Characteristic (RO)C curve Calibration of the score: comparison of predicted and observed risks (Hosmer-Lemeshow test). |
Through study completion, an average of 1 year |
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