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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05176548




Registration number
NCT05176548
Ethics application status
Date submitted
8/11/2021
Date registered
4/01/2022
Date last updated
1/10/2024

Titles & IDs
Public title
Registry of Patients with Suspected Amyloidosis in Heart Failure
Scientific title
Registry of Patients with Suspected Amyloidosis in Heart Failure: Regamic
Secondary ID [1] 0 0
REGAMIC-1450-N-21
Universal Trial Number (UTN)
Trial acronym
Regamic
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Bone-cardiac scintigraphy

Group 1 - Patients in whom Cardiac Amyloidosis is confirmed

Group 2 - Patients in whom Cardiac Amyloidosis is ruled out


Diagnosis / Prognosis: Bone-cardiac scintigraphy
Patients with confirmed ATTR type CA will undergo a study of mutations in the TTR gene
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Differential characteristics between two groups
Timepoint [1] 0 0
Up to two years
Secondary outcome [1] 0 0
Prognostic differences between both groups
Timepoint [1] 0 0
Up to two years
Secondary outcome [2] 0 0
Prognostic differences between two groups
Timepoint [2] 0 0
Up to Two years

Eligibility
Key inclusion criteria
INCLUSION CRITERIA:

* Age = 18 years.
* Both genders.
* Heart Failure (2021 European Society of Cardiology criteria)
* Any LVEF value.
* Outpatients or hospitalized patients in Internal Medicine Units
* Patients with suspicion criteria proposed by the European Society of Cardiology:

* Ventricular hypertrophy = 12 mm

And one or more of the following criteria:

* Heart failure in = 65 years
* Aortic stenosis in = 65 years
* Hypotension or Normotensive if previously hypertensive
* Sensory involvement, autonomic dysfunction
* Peripheral polyneuropathy
* Proteinuria
* Skin bruising (eg, periorbital purpura)
* Bilateral carpal tunnel syndrome
* Ruptured biceps tendon
* In CMR: Subendocardial / transmural late gadolinium enhancement (LGE), or increased extracellular volume (ECV)
* In ECO: Reduced longitudinal strain with apical sparing
* Reduced QRS voltage to mass ratio
* Pseudo Q waves on ECG
* Atrioventricular conduction disease
* Possible family history of ATTRv

EXCLUSION CRITERIA:

* Refusal to participate in the registry
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Spain
State/province [1] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Other
Name
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Observational multicenter registry of cohorts with follow-up.

Patients with heart failure, age = 18 years, with clinical suspicion of cardiac amyloidosis and any LVEF value, treated in the field of Internal Medicine.

Initially, a duration of two years was established to recruit at least 150 patients in the group with AC, and a follow-up of two years.

Upon completion of the two years of follow-up, the continuity or completion of the registry will be assessed.
Trial website
https://clinicaltrials.gov/study/NCT05176548
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Prado Salamanca-Bautista, MD, PhD
Address 0 0
Hospital Universitario Virgen Macarena
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05176548