Prevalence and Prognosis of Cardiac Amiloidosis in Turkey | NCT04915235

Studies
Prevalence and Prognosis of Cardiac Amiloidosis in Turkey

NCT04915235

Sponsor

Turkish Society of Cardiology

Status

Unknown status

Last Update Posted

Jun 7, 2021Actual

Enrollment

2,087Estimated

Phase

Not provided

Conditions

Cardiac Amyloidosis

Interventions

Algorithm

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 18, 2020Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

May 31, 2021

First Submission Date that Met QC Criteria

May 31, 2021

First Posted Date

Jun 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2021

Last Update Posted Date

Jun 7, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients with left ventricular hypertrophy are further examined according to an algorithm to check if they have a cardiac amyloidosis

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,087Estimated

Name	Type	Description	Arm Group Labels	Other Names
Algorithm	Behavioral	Algorithm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiac Amyloidosis	Patients with left ventricular hypertrophy and Cardiac Amyloidosis	Upon screening

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with left ventricular hypertrophy without left ventricular pressure or volume (IVS≥13mm)
Patients with left ventricular hypertrophy and hypertension or aortic stenosis without left ventricular pressure or volume (IVS>15mm)

Exclusion Criteria:

Patients with left ventricular pressure or volume except the ones with aortic stenosis and arterial hypertension
Patients with sigmoid septum and their hypertrophy limited in sigmoid area
Patients with highly probable sarcometric hypertrophy cardiomyopathy confirmed with LV morhpology and genetic testing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with left ventricular hypertrophy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ilkay Gucuk, MD	Contact	902122211738		tkd@tkd.org.tr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dokuz Eylul University Faculty of Medicine	Recruiting	Izmir			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D028227	Amyloid Neuropathies, Familial

Ancestor Terms

ID	Term
D020271	Heredodegenerative Disorders, Nervous System
D019636	Neurodegenerative Diseases
D009422	Nervous System Diseases
D017772	Amyloid Neuropathies

Browse Leaves

Not provided

Browse Branches

Not provided