Heart Failure: Don't Forget the Role of Amyloidosis

NCT05501847 | Unknown

• 1 other identifier: 20_RIPH2-23
• Study Type: interventional
• Target: 446
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Heart Failure

Keywords

Ventricular Hypertrophy; Amyloidosis Cardiac; Transthyretin gene mutation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Patient demographic characteristics

  Baseline

• To compare the clinical characteristics of heart failure patients with cardiac amyloidosis to other causes of heart failure

  Baseline

• To compare the biological (total bilirubin) characteristics of heart failure patients with cardiac amyloidosis to other causes of heart failure

  Baseline

• To compare the biological (BNP or NT-proBNP) characteristics of heart failure patients with cardiac amyloidosis to other causes of heart failure

  Baseline

• To compare the biological (thyroid stimulating hormone) characteristics of heart failure patients with cardiac amyloidosis to other causes of heart failure

  Baseline

Study Arms (2)

Patient with ventricular hypertrophy

NO INTERVENTION

Screening for cardiac amyloidosis in a patient with heart failure and ventricular hypertrophy is performed as part of routine care according to a standardised care protocol that follows the Gullimor algorithm.

Patient with no ventricular hypertrophy

EXPERIMENTAL

In the context of TEAM-HF research, the heart failure patient without ventricular hypertrophy will undergo a bone scan. If the diagnosis of amyloidosis is most often suspected on the electrocardiogram and cardiac echography, only cardiac MRI or bone scan with diphosphonates (for transthyretin amyloidosis) can make the diagnosis.

Radiation: Patient with no ventricular hypertrophy

Interventions

Patient with no ventricular hypertrophy RADIATION

Patients without LVH ≥ 12 mm will routinely receive a bone scan as part of the study. In case of cardiac fixation on bone scan, the patient will be managed as part of routine care according to a standardized care protocol that follows Guillmor's algorithm: monoclonal abnormality testing on biological blood samples +/- genotyping, in order to specify the senile or mutated character of TTR cardiac amyloidosis and to give the genotype.

Patient with no ventricular hypertrophy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Person under legal protection (guardianship, curatorship, safeguard of justice), and person deprived of liberty.

Sponsors & Collaborators

• University Hospital Center of Martinique: lead

Study Sites (2)

Laurent LARIFLA

Pointe-à-Pitre, 97110, Guadeloupe

NOT YET RECRUITING

CHU de Martinique

Fort-de-France, 97261, Martinique

RECRUITING

Related Publications (4)

• 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 P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

  PMID: 27206819 RESULT

• 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.

  PMID: 25950872 RESULT

• 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. 2016 Sep;9(9):e003352. doi: 10.1161/CIRCHEARTFAILURE.116.003352.

  PMID: 27618855 RESULT

• 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 abstract available.

  PMID: 29052438 RESULT

Related Links

• Frequency of cardiac amyloidosis inpatients with unexplained left ventricular hypertrophy: The Caribbean Amyloidosis Study

MeSH Terms

Conditions

Heart Failure; Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Astrid MONFORT BRAFINE, MD

  CHU de Martinique

  STUDY DIRECTOR

Central Study Contacts

Jocelyne CRASPAG, MSc

CONTACT

0596592698; jocelyne.craspag@chu-martinique.fr

Astrid MONFORT BRAFINE, MD

CONTACT

0596306410; astrid.monfort@chu-martinique.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective multicenter interventional study.

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 16, 2022
• Study Start: July 27, 2023
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1); MA (1)