Cardiac AmyloidosisEVAMYLOSENCT04225754
Identification of Prognostic Parameters in Patients With " Senile " Amyloid Cardiomyopathy
An observational study of Cardiac Amyloidosis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The aging of the population is a reality in our society, with a strong increase in the number of elderly patients hospitalized for heart failure in our institutions. Heart failure in these patients is more present than to younger patients, with preserved ejection fraction form (HFpEF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2020to Aug 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Any patient whose standardized etiological investigations have made the diagnosis of a senile amyloid cardiomyopathy in one of the 4 centers of interventional cardiology of the Alpine arc (CHU Grenoble, GHM Grenoble, CH Annecy, and CH Chambery)
Who may be able to join
- Male or female patient, over 75 years old
- Social Security Affiliate
- Any patient with the diagnosis of cardiac amyloidosis after etiological evaluation in one of the 4 Alpin arc interventional cardiology centers (Grenoble University Hospital, GHM Grenoble, Annecy Hospital and Chambéry Hospital).
- Non opposition to participation
Who cannot join
- Concomitant ischemic cardiopathy with revascularization following cardiac scintigraphy exploration and subsequent coronary angiography.
- Concomitant non-amyloid non-ischemic cardiopathy (valvular cardiopathy)
- Major non-cardiac illness (eg, disseminated malignancy, severe neurological dysfunction at the time of diagnosis) or social condition that may preclude participation in a research study
- Major patient protected by law (article L1121-8)
- Person deprived of liberty (Article L1121-8)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Grenoble Alpes
Grenoble, 38043
Clémence Charlon, +33476766652
Charlotte CASSET
About this study
The aging of the population is a reality in our society, with a strong increase in the number of elderly patients hospitalized for heart failure in our institutions. Heart failure in these patients is more present than to younger patients, with preserved ejection fraction form (HFpEF). Aging is responsible for the onset of senile amyloid cardiomyopathy. This pathology is still imperfectly understood and its link with the increase in the frequency of HFpEF is important. In addition, specific treatments have just shown their effectiveness. It is therefore urgent to better identify the prognostic predictive parameters of this cardiomyopathy.
The pathophysiological involvement of the coronary microcirculation responsible for a true microvascular coronary disease (CMVD) has been described as predictive factor in all cardiomyopathies. However the implementation of preventive strategies and / or therapeutic of the coronary microcirculation dysfunction are limited because we lack of diagnostic tests available and applicable to large cohorts of patients.
Our team INSERM U1039 Radiopharmaceutiques Biocliniques in collaboration with the laboratory GIPSA-lab (Grenoble Images Speech Signal Automatique), laboratory specialized in the signal analysis, has developed a new method of analysis allowing to measure the coronary microcirculation dysfunction usable in SPECT thanks to the measurement of a myocardial perfusion heterogeneity index (IHPM) (patented technique). The 3C registry (NCT03479580) is a registry studying the prevalence and cardiovascular prognosis of macro and microcirculatory coronary artery disease using the latest coronary evaluation techniques in patient with cardiomyopathy. This registry deployed on interventional cardiology centers on the Alpine Arc is therefore also addressed to patients with senile cardiomyopathy. The data collected will provide a better understanding of the factors influencing the prognosis of senile cardiomyopathy and the prognostic contribution of the measurement of the IHPM will be evaluated.
- Conditions
- Cardiac Amyloidosis
- Medical subject headings
- Amyloid Neuropathies, Familial
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic value of myocardial perfusion heterogeneity index on mortality at 1 year in patients with senile cardiac amyloidosis.
Rate of occurrence of the primary endpoint: all-cause mortality at 1 year
Measured: 1 year
Secondary outcomes (8)
Prognostic value of IHMP on hospitalizations for heart failure in patients with senile cardiac amyloidosis.
Rate of secondary endpoint: hospitalization for heart failure
Measured: 1 year
Prognostic value of IHPM on the quality of life in patients with senile cardiac amyloidosis
Minnesota Quality of Life Questionnaire
Measured: 1 year
Relationships between IHPM and structural and functional measures in cardiac imaging in cardiac ultrasound
Measurements in cardiac echography (longitudinal, radial and circumferential strain of the left ventricle in speckle tracking, left atrial strain in speckle tracking)
Measured: Inclusion
Relationships between IHPM and structural and functional measures in cardiac imaging in MRI.
Measurement of IHPM in scintigraphy and measurements in cardiac MRI (right and left ventricular function, cardiac mass,% LV fibrosis).
Measured: Inclusion
Correlations between IHMP and geriatric frailty.
grid SEGA-A (short emergency geriatric evaluation)
Measured: Inclusion
Relationships between IHPM in cardiac scintigraphy and the rhythmic evaluations.
Abnormality on holter frequency (atrial fibrillation and / or bradycardia requiring pacemaker implantation).
Measured: inclusion
Comparison of IHPM between patients with amyloid senile cardiomyopathy and a control population paired with age and sex.
Measurement of IHPM in myocardial scintigraphy in patients with senile cardiac amyloidosis and a control population paired with age and sex.
Measured: Inclusion
Side effect of tafamidis in this population
Rate of side effect in function of phenotype of patients (imaging, geriatric evaluation)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start21 Jul 2020
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte CASSET, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225754
- Sponsor's protocol ID
- 38RC19.386
- Other IDs
- 2019-A03024-53
- Acronym
- EVAMYLOSE
- Status last verified
- May 2022
- First submitted
- 30 Dec 2019
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Prognostic Parameters in Patients With " Senile " Amyloid Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04225754
- Acronym / sponsor ID
- EVAMYLOSE / 38RC19.386
- Conditions
- Cardiac Amyloidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 13 Jan 2020 (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.
The aging of the population is a reality in our society, with a strong increase in the number of elderly patients hospitalized for heart failure in our institutions. Heart failure in these patients is more present than to younger patients, with preserved ejection fraction form (HFpEF). Aging is responsible for the onset of senile amyloid cardiomyopathy. This pathology is still imperfectly understood and its link with the increase in the frequency of HFpEF is important. In addition, specific treatments have just shown their effectiveness. It is therefore urgent to better identify the prognostic predictive parameters of this cardiomyopathy.
The pathophysiological involvement of the coronary microcirculation responsible for a true microvascular coronary disease (CMVD) has been described as predictive factor in all cardiomyopathies. However the implementation of preventive strategies and / or therapeutic of the coronary microcirculation dysfunction are limited because we lack of diagnostic tests available and applicable to large cohorts of patients.
Our team INSERM U1039 Radiopharmaceutiques Biocliniques in collaboration with the laboratory GIPSA-lab (Grenoble Images Speech Signal Automatique), laboratory specialized in the signal analysis, has developed a new method of analysis allowing to measure the coronary microcirculation dysfunction usable in SPECT thanks to the measurement of a myocardial perfusion heterogeneity index (IHPM) (patented technique). The 3C registry (NCT03479580) is a registry studying the prevalence and cardiovascular prognosis of macro and microcirculatory coronary artery disease using the latest coronary evaluation techniques in patient with cardiomyopathy. This registry deployed on interventional cardiology centers on the Alpine Arc is therefore also addressed to patients with senile cardiomyopathy. The data collected will provide a better understanding of the factors influencing the prognosis of senile cardiomyopathy and the prognostic contribution of the measurement of the IHPM will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Any patient whose standardized etiological investigations have made the diagnosis of a senile amyloid cardiomyopathy in one of the 4 centers of interventional cardiology of the Alpine arc (CHU Grenoble, GHM Grenoble, CH Annecy, and CH Chambery)
Key inclusion criteria (4 listed)
- Male or female patient, over 75 years old
- Social Security Affiliate
- Any patient with the diagnosis of cardiac amyloidosis after etiological evaluation in one of the 4 Alpin arc interventional cardiology centers (Grenoble University Hospital, GHM Grenoble, Annecy Hospital and Chambéry Hospital).
- Non opposition to participation
Key exclusion criteria (5 listed)
- Concomitant ischemic cardiopathy with revascularization following cardiac scintigraphy exploration and subsequent coronary angiography.
- Concomitant non-amyloid non-ischemic cardiopathy (valvular cardiopathy)
- Major non-cardiac illness (eg, disseminated malignancy, severe neurological dysfunction at the time of diagnosis) or social condition that may preclude participation in a research study
- Major patient protected by law (article L1121-8)
- Person deprived of liberty (Article L1121-8)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognostic value of myocardial perfusion heterogeneity index on mortality at 1 year in patients with senile cardiac amyloidosis.
Time frame: 1 year
Rate of occurrence of the primary endpoint: all-cause mortality at 1 year
8 secondary outcomes
Prognostic value of IHMP on hospitalizations for heart failure in patients with senile cardiac amyloidosis.
Time frame: 1 year
Prognostic value of IHPM on the quality of life in patients with senile cardiac amyloidosis
Time frame: 1 year
Relationships between IHPM and structural and functional measures in cardiac imaging in cardiac ultrasound
Time frame: Inclusion
Relationships between IHPM and structural and functional measures in cardiac imaging in MRI.
Time frame: Inclusion
Correlations between IHMP and geriatric frailty.
Time frame: Inclusion
Relationships between IHPM in cardiac scintigraphy and the rhythmic evaluations.
Time frame: inclusion
Comparison of IHPM between patients with amyloid senile cardiomyopathy and a control population paired with age and sex.
Time frame: Inclusion
Side effect of tafamidis in this population
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Charlotte CASSET principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Amyloidosis, run by University Hospital, Grenoble at 1 site in France.
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 4 inclusion and 5 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 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Charlotte Casset, Dr (+33476763627, ccasset@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic value of myocardial perfusion heterogeneity index on mortality at 1 year in patients with senile cardiac amyloidosis. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2022.