Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-03-27 @ 11:28 PM
Study NCT ID:
NCT06427304
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2024-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D028227', 'term': 'Amyloid Neuropathies, Familial'}], 'ancestors': [{'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017772', 'term': 'Amyloid Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D028226', 'term': 'Amyloidosis, Familial'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 637}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-02-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2024-04-24', 'studyFirstSubmitQcDate': '2024-05-21', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the number of patients with cardiac amyloidosis according bon scintigraphy', 'timeFrame': 'At inclusion'}], 'secondaryOutcomes': [{'measure': 'Assessment of commorbidity risk according Charlson Comorbidity Index (CCI)', 'timeFrame': 'At inclusion', 'description': 'The Charlson Comorbidity Index (CCI) assesses the level of comorbidity by considering the level of severity of 19 predefined comorbid disorders and the number of disorders present among them.'}, {'measure': 'Assessment of the degree of patient dependence according Katz Index of Independence in Activities of Daily Living (ADL)', 'timeFrame': 'At inclusion', 'description': 'Katz Index of Independence in Activities of Daily Living is an unabbreviated scale title.\n\nThis Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Patients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.'}, {'measure': 'Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score', 'timeFrame': 'At inclusion', 'description': 'The Mini-Mental State Examination is an unabbreviated scale title. This scale was developed as a brief screening tool to provide a quantitative evaluation of cognitive impairment and to record cognitive changes over time.\n\nThe measure yields a total score of 30. A score of 23 or less is the generally accepted cutoff point indicating the presence of cognitive impairment. Levels of impairment have also been classified as none (24-30); mild (18-23) and severe (0-17)'}, {'measure': 'Estimating the probability of neuropathic pain according "DN4 Questionnaire"', 'timeFrame': 'At inclusion', 'description': 'This questionnaire is an unabbreviated score title, it was originally developed and validated in French (4 items of neuropathic pain). It was identified as one of the most suitable neuropathic pain screening tools for clinical use:\n\n* Sensitivity: Ranges from 75-98%. Proven high sensitivity for central neuropathic pain and polyneuropathies. Sensitivity is low for tigeminal neuralgia. Moderate sensitivity for detecting a neuropathic component of pain in people with chronic pain.\n* Specificity: Ranges from 37-96%.'}, {'measure': 'Assessment of physical frailty according Fried scale', 'timeFrame': 'At inclusion', 'description': 'This is an unabbreviated scale title.\n\nAssessment of 5 dimensions:\n\n* 0, 1 or 2 pathological dimensions = lack of frailty\n* 3, 4 or 5 pathological dimensions = presence of frailty'}, {'measure': 'Assessment of Failty status using the Short Emergency Geriatric Assessment (SEGA)', 'timeFrame': 'At inclusion', 'description': 'This is an unabbreviated scale title.\n\n* if SEGA score \\< ou = 8 : Not very frail\n* if it contained in the interval \\[9;11\\] : Rather frail\n* if it \\> ou = 12 : Very frail'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac amyloidosis', 'Heart failure with left ventricular hypertrophy', 'Positive bone scintigraphy'], 'conditions': ['Cardiac Amyloidosis']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'Patients recruitment will be curry out in 31 geriatric or cardiologic centres.\n\nPatients 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).\n\nThe 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.\n\nBone 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.\n\nThe results of each examination will be evaluated to establish the existence and degree of fixation in the myocardium and to determine its distribution.\n\nFollow-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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cardiac amyloidosis expressed by a positive bone scintigraphy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 80 years\n* Hospitalised for decompensation of heart failure in the last 12 months\n* Subjects with hypertrophy of the septum or left ventricle at cardiac echography (defined as ≥ 12 mm)\n* Subjects able to undergo a bone scintigraphy scan\n* Subjects willing to participate\n\nExclusion Criteria:\n\n* Subjects refusing to participate\n* Subjects admitted to palliative care unit.\n* Subjects under guardianship\n* Subjects with a definite diagnosis of cardiac amyloidosis'}, 'identificationModule': {'nctId': 'NCT06427304', 'acronym': 'ARNOLD', 'briefTitle': 'Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure', 'organization': {'class': 'OTHER', 'fullName': "Gérond'if"}, 'officialTitle': 'Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure', 'orgStudyIdInfo': {'id': '2023-A01313-42'}}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'state': 'IIe-de-France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Hanon, MD PhD', 'role': 'CONTACT', 'email': 'olivier.hanon@aphp.fr', 'phone': '+33 (0)144083503'}], 'facility': 'Geriatric Department, Broca Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '44000', 'city': 'Nantes', 'state': 'Loire-Atlantique', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne Sophie BOUREAU, MD', 'role': 'CONTACT'}], 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '76000', 'city': 'Rouen', 'state': 'Normandy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric ROCA, MD', 'role': 'CONTACT'}], 'facility': 'CHU Rouen, Charles Nicole hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '86000', 'city': 'Poitiers', 'state': 'Nouvelle-Aquitaine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc PACCALIN, MD, PHD', 'role': 'CONTACT'}], 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '34090', 'city': 'Montpellier', 'state': 'Occitanie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hubert BLAIN, MD, PHD', 'role': 'CONTACT'}], 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '31300', 'city': 'Toulouse', 'state': 'Occitanie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier TOULZA, MD', 'role': 'CONTACT'}], 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '80000', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nysrine BENNOUNA, MD', 'role': 'CONTACT'}], 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49100', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cédric NNWEILER, MD, PHD', 'role': 'CONTACT'}], 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '33000', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle BOURDEL-MARCHASSON, MD, PHD', 'role': 'CONTACT'}], 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '11100', 'city': 'Carcassonne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hanna BAKANOVA, Dr', 'role': 'CONTACT'}], 'facility': 'Centre Hospitalier de Carcassonne', 'geoPoint': {'lat': 43.21649, 'lon': 2.34863}}, {'zip': '81100', 'city': 'Castres', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Soumiya MENHOUR, MD', 'role': 'CONTACT'}], 'facility': 'Centre Hospitalier Intercommunal de Castres-Mazamet', 'geoPoint': {'lat': 43.60527, 'lon': 2.24088}}, {'zip': '37170', 'city': 'Chambray-lès-Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent FAUCHIER, MD, PHD', 'role': 'CONTACT'}], 'facility': 'CHU Trousseau-Tours', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '21000', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérémie VOVELLE, MD', 'role': 'CONTACT'}], 'facility': 'CHU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38700', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laure ALLAN-PATTOGLIA, MD', 'role': 'CONTACT'}], 'facility': 'CHU Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59000', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François PUISIEUX, MD, PHD', 'role': 'CONTACT'}], 'facility': 'CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87000', 'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Achille TCHALLA, MD', 'role': 'CONTACT'}], 'facility': 'CHU Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69002', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Michel CHUZEVILLE, MD', 'role': 'CONTACT'}], 'facility': 'CHU Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13005', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Laure COUDERC, MD, PHD', 'role': 'CONTACT'}], 'facility': 'CHU Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34000', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe GALLET DE SANTERRE, Dr', 'role': 'CONTACT'}], 'facility': 'Clinique du Millénaire-Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54000', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laure JOLY, MD', 'role': 'CONTACT'}], 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '06000', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier GUERIN, MD, PHD', 'role': 'CONTACT'}], 'facility': 'CHU Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '06100', 'city': 'Nice', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Marie BARISIC, MD', 'role': 'CONTACT'}], 'facility': 'Hôpital Privé Gériatrique LES SOURCES-Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '45100', 'city': 'Orléans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Matthieu COULONGEAT, MD', 'role': 'CONTACT'}], 'facility': 'CHU Orléans', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '35000', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dominique SOMME, MD, PHD', 'role': 'CONTACT'}, {'name': 'Erwan DONAL, MD, PhD', 'role': 'CONTACT'}], 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '37000', 'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand FOUGERE, MD, PHD', 'role': 'CONTACT'}], 'facility': 'CHRU Tours-Bretonneau Hospital', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '49800', 'city': 'Trélazé', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laureen LABORY, MD', 'role': 'CONTACT'}], 'facility': 'Clinique Saint Joseph Trelaze', 'geoPoint': {'lat': 47.44629, 'lon': -0.46652}}, {'zip': '69100', 'city': 'Villeurbanne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine JOBBE-DUVAL, MD', 'role': 'CONTACT'}], 'facility': 'Médipôle Hôpital Mutualiste Villeurbanne', 'geoPoint': {'lat': 45.76601, 'lon': 4.8795}}, {'zip': '92100', 'city': 'Boulogne-Billancourt', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marion PEPIN, MD', 'role': 'CONTACT'}], 'facility': 'Ambroise Paré Hospital', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '92130', 'city': 'Issy-les-Moulineaux', 'state': 'Île-de-France Region', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anthony MEZIERE, MD', 'role': 'CONTACT'}], 'facility': 'Corentin Celton Hospital', 'geoPoint': {'lat': 48.82104, 'lon': 2.27718}}, {'zip': '94200', 'city': 'Ivry-sur-Seine', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Joël BELMIN, MD, PHD', 'role': 'CONTACT'}], 'facility': 'Charles Foix Hospital', 'geoPoint': {'lat': 48.81568, 'lon': 2.38487}}, {'zip': '94450', 'city': 'Limeil-Brévannes', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amaury BROUSSIER, MD', 'role': 'CONTACT'}], 'facility': 'Emile Roux Hospital', 'geoPoint': {'lat': 48.7448, 'lon': 2.48705}}, {'zip': '77000', 'city': 'Melun', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cyrus MOÏNI, MD', 'role': 'CONTACT'}], 'facility': 'GH Sud Ile-de-France', 'geoPoint': {'lat': 48.5457, 'lon': 2.65356}}, {'zip': '75010', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Matthieu LILAMAND, MD', 'role': 'CONTACT'}], 'facility': 'Lariboisière Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yara ANTAKLY HANON, MD', 'role': 'CONTACT'}], 'facility': 'Saint Joseph Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elena PAILLAUD, MD, PHD', 'role': 'CONTACT'}], 'facility': 'Europeen Georges Pompidou Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Virginie FOSSEY-DIAZ, MD', 'role': 'CONTACT'}], 'facility': 'Bretonneau Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Isabelle Dufour', 'role': 'CONTACT', 'email': 'isabelle.dufour@gerondif.org', 'phone': '+33 (0) 185781011'}, {'name': 'Prisca Lucas, MPH PhD', 'role': 'CONTACT', 'email': 'prisca.lucas@gerondif.org', 'phone': '+33 (0)185737323'}], 'overallOfficials': [{'name': 'Olivier Hanon, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Geriatric Department, Broca hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gérond'if", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}