NCT05896904

Brief Summary

Clinical comparison of patients with transthyretin cardiac amyloidosis and patients with heart failure with reduced ejection fraction

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

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 9, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

June 9, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

May 31, 2023

Last Update Submit

May 31, 2023

Conditions

Transthyretin Amyloid CardiomyopathyHeart Failure

Keywords

Heart FailureEchocardiography

Outcome Measures

Primary Outcomes (1)

  • intraventricular wall thickness

    echocardiographic measurement

    1 year

Study Arms (1)

Echocardiography

EXPERIMENTAL
Diagnostic Test: Echocardiography

Interventions

EchocardiographyDIAGNOSTIC_TEST

Echocardiography

Echocardiography

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age \>65
  • ATTRwt diagnosis for patients, either with DPD-scintigraphy or myocardiac biopsy
  • informed consent

You may not qualify if:

  • Alder \<65
  • No ATTRwt diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Valentin R Klarskov, Bachelor

    Clinic of heart diseases, AUH.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 9, 2023

Study Start

September 9, 2022

Primary Completion

March 6, 2023

Study Completion

August 31, 2023

Last Updated

June 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)