## Protocol Section
### Identification Module
**NCT ID:** NCT06427304

**Acronym:** ARNOLD

**Brief Title:** Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure

**Official Title:** Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure

#### Organization Study ID Info
**ID:** 2023-A01313-42
#### Organization
**Class:** OTHER
**Full Name:** Gérond'if
### Status Module
#### Completion Date
**Date:** 2027-12-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-05-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-24
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Gérond'if

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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

**Detailed Description:** 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

### Conditions Module

**Conditions:**

- Cardiac Amyloidosis

**Keywords:**

- Cardiac amyloidosis

- Heart failure with left ventricular hypertrophy

- Positive bone scintigraphy

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 637

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Assessment of the number of patients with cardiac amyloidosis according bon scintigraphy

**Time Frame:** At inclusion

#### Secondary Outcomes

**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 commorbidity risk according Charlson Comorbidity Index (CCI)

**Time Frame:** At inclusion

**Description:** Katz Index of Independence in Activities of Daily Living is an unabbreviated scale title.

This 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:** Assessment of the degree of patient dependence according Katz Index of Independence in Activities of Daily Living (ADL)

**Time Frame:** 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.

The 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:** Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score

**Time Frame:** 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:

* 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.
* Specificity: Ranges from 37-96%.

**Measure:** Estimating the probability of neuropathic pain according "DN4 Questionnaire"

**Time Frame:** At inclusion

**Description:** This is an unabbreviated scale title.

Assessment of 5 dimensions:

* 0, 1 or 2 pathological dimensions = lack of frailty
* 3, 4 or 5 pathological dimensions = presence of frailty

**Measure:** Assessment of physical frailty according Fried scale

**Time Frame:** At inclusion

**Description:** This is an unabbreviated scale title.

* if SEGA score \< ou = 8 : Not very frail
* if it contained in the interval \[9;11\] : Rather frail
* if it \> ou = 12 : Very frail

**Measure:** Assessment of Failty status using the Short Emergency Geriatric Assessment (SEGA)

**Time Frame:** At inclusion

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 80 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

**Study Population:** Patients with cardiac amyloidosis expressed by a positive bone scintigraphy.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** isabelle.dufour@gerondif.org

**Name:** Isabelle Dufour

**Phone:** +33 (0) 185781011

**Role:** CONTACT

**Contact 2:**

**Email:** prisca.lucas@gerondif.org

**Name:** Prisca Lucas, MPH PhD

**Phone:** +33 (0)185737323

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Email:** olivier.hanon@aphp.fr

- **Name:** Olivier Hanon, MD PhD

- **Phone:** +33 (0)144083503

- **Role:** CONTACT

**Country:** France

**Facility:** Geriatric Department, Broca Hospital

**State:** IIe-de-France

**Zip:** 75013

#### Overall Officials

**Official 1:**

**Affiliation:** Geriatric Department, Broca hospital

**Name:** Olivier Hanon, MD PhD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000057165

- Term: Proteostasis Deficiencies

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M10035

- Name: Hypertrophy

- Relevance: LOW

- As Found: Unknown

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M4021

- Name: Amyloidosis

- Relevance: HIGH

- As Found: Amyloidosis

- ID: M19658

- Name: Hypertrophy, Left Ventricular

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M28747

- Name: Proteostasis Deficiencies

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

- ID: D000000686

- Term: Amyloidosis

### Misc Info Module

- Version Holder: 2024-05-31
