NCT04915235

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,087

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 7, 2021

Status Verified

May 1, 2021

Enrollment Period

5.3 years

First QC Date

May 31, 2021

Last Update Submit

May 31, 2021

Conditions

Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (1)

  • Cardiac Amyloidosis

    Patients with left ventricular hypertrophy and Cardiac Amyloidosis

    Upon screening

Interventions

AlgorithmBEHAVIORAL

Algorithm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with left ventricular hypertrophy

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University Faculty of Medicine

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Interventions

Algorithms

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesAmyloid NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmyloidosis, FamilialMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAmyloidosisProteostasis Deficiencies

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Central Study Contacts

Ilkay Gucuk, MD

CONTACT

902122211738tkd@tkd.org.tr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 7, 2021

Study Start

September 18, 2020

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 7, 2021

Record last verified: 2021-05

Locations

TU(1)