ClinicalTrials.gov record NCT06427304

Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age80 years old and older
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective, observational multicentre study that aims to find how common cardiac amyloidosis is among older patients hospitalized for heart failure with left ventricular hypertrophy. It focuses on people aged 80 and older and collects medical, geriatric and imaging data including bone scintigraphy (99mTc-DPD or 99mTc-HMDP). Participants have a baseline visit and a bone scan, then phone follow-ups every 3 months for 12 months.

What it is studying. The study is measuring how often cardiac amyloidosis is present in geriatric patients who were hospitalized for heart failure and have left ventricular hypertrophy. To do this, it collects clinical and demographic information, geriatric assessments and imaging (bone scintigraphy), plus genetic and echocardiography data, and tracks hospitalizations, admissions to long‑term care and deaths over 12 months.

What the researchers hope to learn. To estimate the prevalence of cardiac amyloidosis detected by bone scintigraphy in older patients hospitalized for heart failure with left ventricular hypertrophy; to describe the degree and pattern of tracer uptake in the heart; and to describe participants' comorbidity, dependence, cognitive status, frailty, and neuropathic pain screening at inclusion.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Tne aim purpose of this observational, multicentre and propective study is to determine the prevalence of cardiac amyloidosis in geriatric patients aged 80 years and older hospitalized within the last 12 months for heart failure with left ventricular hypertrophy (septum ≥ 12 mm) on echocardiography

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Aged ≥ 80 years
  • Hospitalised for decompensation of heart failure in the last 12 months
  • Subjects with hypertrophy of the septum or left ventricle at cardiac echography (defined as ≥ 12 mm)
  • Subjects able to undergo a bone scintigraphy scan
  • Subjects willing to participate

Exclusion criteria

  • Subjects refusing to participate
  • Subjects admitted to palliative care unit.
  • Subjects under guardianship
  • Subjects with a definite diagnosis of cardiac amyloidosis

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Patients recruitment will be curry out in 31 geriatric or cardiologic centres. Patients will be recruited for 24 months. Each patient will participate in the study for 12 months (baseline visit, follow-up phone calls every 3 months up to 12 months i.e., at 3, 6, 9 and 12 months). The following data will be collected at teh baseline visit: Medical history, demography, clinical data, frailty status assessed by Fried, Triage Risk Screening Tool (TRST), triggers for cardiac decompensation, biological examination, genetic testing, echocardiographic data and other data. Bone scanning with 99mTc-DPD or 99mTc-HMDP (early or late time with SPECT will be done during hospitalization or after discharge depending on availability at the imaging centre. The results of each examination will be evaluated to establish the existence and degree of fixation in the myocardium and to determine its distribution. Follow-up phone s will be conducted every 3 months up to 12 months to collect hospitalizations for heart failure, hospitalizations for other cardio-vascular events, hospitalizations for non-cardiac events, admission to nursing homes or long-term care (LTC) facilities and death

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants take part for 12 months: a baseline visit and telephone follow-ups every 3 months (at 3, 6, 9 and 12 months). At the baseline visit the study collects medical history, demographic and clinical information, frailty and cognitive assessments (Fried, TRST, SEGA, Katz ADL, MMSE, DN4), biological tests and genetic testing, and echocardiographic data. Bone scintigraphy with 99mTc‑DPD or 99mTc‑HMDP (with possible SPECT imaging) will be performed during hospitalization or after discharge; the results will be evaluated for myocardial fixation and distribution. Follow-up calls will record hospitalizations (for heart failure, other cardiovascular or non-cardiac events), admissions to nursing homes or long-term care, and death.

How the study is structured. This is a prospective, case-only observational study run at multiple geriatric and cardiology centres. Each participant has a baseline visit where medical history, demographics, clinical data, frailty and other geriatric assessments, biological testing, genetic testing, and echocardiographic data are recorded. Bone scanning with 99mTc-DPD or 99mTc-HMDP (with SPECT imaging) is done during hospitalization or after discharge when available. Follow-up phone calls occur every 3 months (at 3, 6, 9 and 12 months) to record hospitalizations, admissions to nursing or long‑term care, and death. Recruitment is planned across many centres over 24 months; each person is followed for 12 months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Cardiac Amyloidosis. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

This trial is also listed on this site under wild-type ATTR amyloidosis.

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jul 1, 2024
Primary completion
Jul 2, 2027 (estimated)
Study completion
Feb 2, 2028 (estimated)
Target enrollment
637 participants (estimated)
Last updated on registry
Apr 20, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Gérond'if

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (36)

  • Geriatric Department, Broca HospitalRecruiting

    Paris, IIe-de-France, 75013 · France

  • CHU NantesRecruiting

    Nantes, Loire-Atlantique, 44000 · France

    • Anne Sophie BOUREAU, MD
  • CHU PoitiersRecruiting

    Poitiers, New Aquitaine, 86000 · France

    • Marc PACCALIN, MD, PHD
  • CHU Rouen, Charles Nicole hospitalRecruiting

    Rouen, Normandy, 76000 · France

    • Frédéric ROCA, MD
  • CHU MontpellierRecruiting

    Montpellier, Occitanie, 34090 · France

    • Hubert BLAIN, MD, PHD
  • CHU ToulouseRecruiting

    Toulouse, Occitanie, 31300 · France

    • Olivier TOULZA, MD
  • CHU Amiens PicardieRecruiting

    Amiens, 80000 · France

    • Nysrine BENNOUNA, MD
  • CHU AngersRecruiting

    Angers, 49100 · France

    • Cédric NNWEILER, MD, PHD
  • CHU BordeauxRecruiting

    Bordeaux, 33000 · France

    • Isabelle BOURDEL-MARCHASSON, MD, PHD
  • Centre Hospitalier de CarcassonneRecruiting

    Carcassonne, 11100 · France

    • Hanna BAKANOVA, Dr

Terms used on this page · explanations by MedicalUpdates.ai

echocardiography
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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