Heart FailureTEAM-HFNCT05501847
Heart Failure: Don't Forget the Role of Amyloidosis
A study testing Patient with no ventricular hypertrophy in people with Heart Failure, run by University Hospital Center of Martinique at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Patient with no ventricular hypertrophy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Jul 2023to Jun 2024
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Person under legal protection (guardianship, curatorship, safeguard of justice), and person deprived of liberty.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Guadeloupe1 site, 1 recruiting
- Not yet recruiting
Laurent LARIFLA
Pointe-à-Pitre, 97110
Laurent LARIFLA, MD, Sc.D, 0590891420 ext. +590, laurent.larifla@chu-guadeloupe.fr
Laurent LARIFLA, MD, Sc.D
Martinique1 site, 1 recruiting
- Recruiting
CHU de Martinique
Fort-de-France, 97261
Astrid MONFORT BRAFINE, MD, 0596306410 ext. +596, astrid.monfort@chu-martinique.fr
Astrid MONFORT BRAFINE, MD
About this study
Official title: Prevalence of Cardiac Amyloidosis in Patients With Hospitalization for Acute Heart Failure in the French West Indies
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.
Read more
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.
Read the detailed description
The heart supplies the organs with oxygen and nutrient-rich blood. During exercise, the heart adapts by increasing the rate of contraction and the rate of blood flow.
Heart failure occurs when the heart loses its muscular strength and its normal capacity to contract; it no longer pumps enough blood to allow the organs to receive enough oxygen and nutrients, which are essential for their proper functioning.
This syndrome is frequent and serious with a prevalence of 2 to 3% in Europe and a high morbidity and mortality (1st cause of hospitalization with more than 150,000 hospitalizations per year in France, a mortality of 50% at 5 years, i.e. more than most cancers). This mortality is even higher in the West Indies, with an excess of premature mortality related to heart failure of +32.9% in Martinique and +86.9% in Guadeloupe compared with metropolitan France (average annual mortality rate for heart failure in 2008-2010 per 100,000 in habitants under 65 years of age).
Some studies have indeed shown a higher prevalence of heart failure in the Afro-Caribbean and Afro-American population with etiologies that differ from the Caucasian population. Among them, transthyretin (TTR) amyloidosis is rare in Europe but very common in African descendants with a prevalence of 3.4% of a transthyretin gene mutation (V122l) in this population (likely to induce hereditary amyloidosis after the fifth decade). It is a serious disease with a median survival of 2 to 6 years depending on the study and is often under-diagnosed with late detection at the time of a major cardiovascular event, such as a stroke or acute heart failure. Screening is done by imaging (cardiac MRI or bone scintigraphy with labelled diphosphonates). According to a study carried out in the Cardiology Department of the Martinique University Hospital (TEAM Amyloidosis study), one out of three left ventricular hypertrophy (LVH) (parietal thickness ≥ 15 mm), diagnosed by echocardiography, is amyloidosis. A study published by Thibaud Damy's team in 2015 already found a 5% prevalence of TTR gene mutation in patients with LVH. It is now accepted that systematic screening for amyloidosis is necessary in cases of LVH > 12 mm associated with at least one risk factor for amyloidosis ("red flags") in order to implement appropriate therapies and thus improve patient survival.
The study by Dungu et al. reports that cardiac amyloidosis is an underestimated etiology of acute heart failure in Afro-Caribbean immigrants in London. The study found a high prevalence of cardiac amyloidosis at 11.4% among 211 African-Caribbean immigrants compared to a Caucasian population (1.6%), with a higher mortality of these patients compared to patients with another cause of heart failure (median survival 2.3 years versus 7 years for other etiologies). The study by Arvanitis et al. describes a 5.1% prevalence of the transthyretin gene mutation (V122l) in 101 African Americans with heart failure (compared to 8.5% of mutation carriers among African-Caribbean immigrants in the Dungu study).
In these two studies, the prevalences of amyloidosis and the V122I mutation are probably underestimated, given the absence of systematic screening of all heart failure cases and the fact that only patients with left ventricular hypertrophy on transthoracic echography were targeted.
In addition, amyloidosis can take different forms from those usually described. Occasional observations in our experience at the University Hospital of Martinique have found cases of heart failure with dilated cardiomyopathy (DCM), associated with transthyretin cardiac amyloidosis. Several similar observations have been found in the literature.
The study hypothesise is that cardiac amyloidosis is as common, or more common, in acute heart failure in the French West Indies than elsewhere. A systematic screening for amyloidosis in all patients with acute heart failure would allow early initiation of appropriate treatment and improve their long-term outcome.
- Conditions
- Heart Failure
- Being tested
- Patient with no ventricular hypertrophy
- Keywords
- Ventricular Hypertrophy, Amyloidosis Cardiac, Transthyretin gene mutation
- Medical subject headings
- Heart Failure, Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient with no ventricular hypertrophyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Patient with no ventricular hypertrophy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months +/- 8 days post inclusion
Secondary outcomes (11)
Patient demographic characteristics
Age, gender, ethnicity, locality
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline or through visit T2, an average of 6 months
Describe the cases of amyloidosis identified according to the severity of cardiac involvement
Extra-cardiac impact (renal and liver function)
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline or up to 24 weeks post inclusion
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).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start27 Jul 2023
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective multicenter interventional study.
- Masking
- None (open label)
- Enrolment
- 446 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Astrid MONFORT BRAFINE, MD, Study director, CHU de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501847
- Sponsor's protocol ID
- 20_RIPH2-23
- Acronym
- TEAM-HF
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2022
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27206819Gabet 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.
PubMed 25950872Dungu 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.
PubMed 27618855Arvanitis 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.
PubMed 29052438
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Cardiac Amyloidosis in Patients With Hospitalization for Acute Heart Failure in the French West Indies
- ClinicalTrials.gov ID
- NCT05501847
- Acronym / sponsor ID
- TEAM-HF / 20_RIPH2-23
- Conditions
- Heart Failure
- Keywords
- Ventricular Hypertrophy, Amyloidosis Cardiac, Transthyretin gene mutation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 446 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 16 Aug 2022 (actual)
- 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.
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.
Detailed description
The heart supplies the organs with oxygen and nutrient-rich blood. During exercise, the heart adapts by increasing the rate of contraction and the rate of blood flow.
Heart failure occurs when the heart loses its muscular strength and its normal capacity to contract; it no longer pumps enough blood to allow the organs to receive enough oxygen and nutrients, which are essential for their proper functioning.
This syndrome is frequent and serious with a prevalence of 2 to 3% in Europe and a high morbidity and mortality (1st cause of hospitalization with more than 150,000 hospitalizations per year in France, a mortality of 50% at 5 years, i.e. more than most cancers). This mortality is even higher in the West Indies, with an excess of premature mortality related to heart failure of +32.9% in Martinique and +86.9% in Guadeloupe compared with metropolitan France (average annual mortality rate for heart failure in 2008-2010 per 100,000 in habitants under 65 years of age).
Some studies have indeed shown a higher prevalence of heart failure in the Afro-Caribbean and Afro-American population with etiologies that differ from the Caucasian population. Among them, transthyretin (TTR) amyloidosis is rare in Europe but very common in African descendants with a prevalence of 3.4% of a transthyretin gene mutation (V122l) in this population (likely to induce hereditary amyloidosis after the fifth decade). It is a serious disease with a median survival of 2 to 6 years depending on the study and is often under-diagnosed with late detection at the time of a major cardiovascular event, such as a stroke or acute heart failure. Screening is done by imaging (cardiac MRI or bone scintigraphy with labelled diphosphonates). According to a study carried out in the Cardiology Department of the Martinique University Hospital (TEAM Amyloidosis study), one out of three left ventricular hypertrophy (LVH) (parietal thickness ≥ 15 mm), diagnosed by echocardiography, is amyloidosis. A study published by Thibaud Damy's team in 2015 already found a 5% prevalence of TTR gene mutation in patients with LVH. It is now accepted that systematic screening for amyloidosis is necessary in cases of LVH > 12 mm associated with at least one risk factor for amyloidosis ("red flags") in order to implement appropriate therapies and thus improve patient survival.
The study by Dungu et al. reports that cardiac amyloidosis is an underestimated etiology of acute heart failure in Afro-Caribbean immigrants in London. The study found a high prevalence of cardiac amyloidosis at 11.4% among 211 African-Caribbean immigrants compared to a Caucasian population (1.6%), with a higher mortality of these patients compared to patients with another cause of heart failure (median survival 2.3 years versus 7 years for other etiologies). The study by Arvanitis et al. describes a 5.1% prevalence of the transthyretin gene mutation (V122l) in 101 African Americans with heart failure (compared to 8.5% of mutation carriers among African-Caribbean immigrants in the Dungu study).
In these two studies, the prevalences of amyloidosis and the V122I mutation are probably underestimated, given the absence of systematic screening of all heart failure cases and the fact that only patients with left ventricular hypertrophy on transthoracic echography were targeted.
In addition, amyloidosis can take different forms from those usually described. Occasional observations in our experience at the University Hospital of Martinique have found cases of heart failure with dilated cardiomyopathy (DCM), associated with transthyretin cardiac amyloidosis. Several similar observations have been found in the literature.
The study hypothesise is that cardiac amyloidosis is as common, or more common, in acute heart failure in the French West Indies than elsewhere. A systematic screening for amyloidosis in all patients with acute heart failure would allow early initiation of appropriate treatment and improve their long-term outcome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective multicenter interventional study.
| Arm | Type | Receives |
|---|---|---|
| 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 | Radiation: Patient with no ventricular hypertrophyIn 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Person under legal protection (guardianship, curatorship, safeguard of justice), and person deprived of liberty.
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 |
|---|---|---|
| Patient with no ventricular hypertrophyPatients 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. | Radiation | Patient with no ventricular hypertrophy |
Primary outcome
Prevalence of cardiac amyloidosis in acute heart failure patients in the French West Indies
Time frame: 18 months +/- 8 days post inclusion
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.
11 secondary outcomes
Patient demographic characteristics
Time frame: Baseline
To compare the clinical characteristics of heart failure patients with cardiac amyloidosis to other causes of heart failure
Time frame: Baseline
To compare the biological (total bilirubin) characteristics of heart failure patients with cardiac amyloidosis to other causes of heart failure
Time frame: Baseline
To compare the biological (BNP or NT-proBNP) characteristics of heart failure patients with cardiac amyloidosis to other causes of heart failure
Time frame: Baseline
To compare the biological (thyroid stimulating hormone) characteristics of heart failure patients with cardiac amyloidosis to other causes of heart failure
Time frame: Baseline
To compare the biological (High-sensitivity (hs) cardiac troponin (cTn)) characteristics of heart failure patients with cardiac amyloidosis to other causes of heart failure
Time frame: Baseline
To compare the genotypic characteristics of heart failure patients with cardiac amyloidosis to other causes of heart failure
Time frame: Baseline or through visit T2, an average of 6 months
Describe the cases of amyloidosis identified according to the severity of cardiac involvement
Time frame: Baseline
Describe the cases of amyloidosis according to the severity of the heart failure
Time frame: Baseline
Ultrasound criteria predictive of amyloid with or no LVH ≥12 mm
Time frame: Baseline or up to 24 weeks post inclusion
Diagnostic score for cardiac amyloidosis in acute heart failure
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Results publication: PubMed 27206819Ponikowski 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.
- Results publication: PubMed 25950872Gabet 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.
- Results publication: PubMed 27618855Dungu 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.
- Results publication: PubMed 29052438Arvanitis 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.
- Frequency of cardiac amyloidosis inpatients with unexplained left ventricular hypertrophy: The Caribbean Amyloidosis StudyLink provided by the sponsor.
- 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.
Astrid MONFORT BRAFINE, MD study director
CHU de Martinique
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient with no ventricular hypertrophy in people with Heart Failure, run by University Hospital Center of Martinique at 2 sites in 2 countries.
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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Guadeloupe, Martinique. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jocelyne CRASPAG, MSc (0596592698 ext. +596, jocelyne.craspag@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of cardiac amyloidosis in acute heart failure patients in the French West Indies (time frame: 18 months +/- 8 days post inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05501847, which also lists 4 linked publications.
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 28 Aug 2023.