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Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction

Primary Purpose

Transthyretin Amyloid Cardiomyopathy, Heart Failure

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Echocardiography
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Transthyretin Amyloid Cardiomyopathy focused on measuring Heart Failure, Echocardiography

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age >65 ATTRwt diagnosis for patients, either with DPD-scintigraphy or myocardiac biopsy informed consent Exclusion Criteria: Alder <65 No ATTRwt diagnosis

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Echocardiography

Arm Description

Outcomes

Primary Outcome Measures

intraventricular wall thickness
echocardiographic measurement

Secondary Outcome Measures

Full Information

First Posted
May 31, 2023
Last Updated
May 31, 2023
Sponsor
Aarhus University Hospital Skejby
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1. Study Identification

Unique Protocol Identification Number
NCT05896904
Brief Title
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
Official Title
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
March 6, 2023 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital Skejby

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transthyretin Amyloid Cardiomyopathy, Heart Failure
Keywords
Heart Failure, Echocardiography

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Echocardiography
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Echocardiography
Intervention Description
Echocardiography
Primary Outcome Measure Information:
Title
intraventricular wall thickness
Description
echocardiographic measurement
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >65 ATTRwt diagnosis for patients, either with DPD-scintigraphy or myocardiac biopsy informed consent Exclusion Criteria: Alder <65 No ATTRwt diagnosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentin R Klarskov, Bachelor
Organizational Affiliation
Clinic of heart diseases, AUH.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction

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