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

• Sponsor: Aarhus University Hospital Skejby (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05896904
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 11.7
• Patients Per Site Per Month: 8.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Transthyretin Amyloid Cardiomyopathy; Heart Failure	Diagnostic Test: Echocardiography	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
• Actual Study Start Date: Sep 9, 2022
• Actual Primary Completion Date: Mar 6, 2023
• Anticipated Study Completion Date: Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Echocardiography	Diagnostic Test: Echocardiography; Echocardiography

Outcome Measures

Primary Outcome Measures

1. intraventricular wall thickness [1 year]

   echocardiographic measurement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age >65

• ATTRwt diagnosis for patients, either with DPD-scintigraphy or myocardiac biopsy

• informed consent

Exclusion Criteria:

• Alder <65

• No ATTRwt diagnosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus		Denmark	8200

Sponsors and Collaborators

• Aarhus University Hospital Skejby

Investigators

• Principal Investigator: Valentin R Klarskov, Bachelor, Clinic of heart diseases, AUH.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steen Hvitfeldt Poulsen, Professor, Aarhus University Hospital Skejby
• ClinicalTrials.gov Identifier: NCT05896904
• Other Study ID Numbers: 1-10-72-380-21
• First Posted: Jun 9, 2023
• Last Update Posted: Jun 9, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Steen Hvitfeldt Poulsen, Professor, Aarhus University Hospital Skejby: Heart Failure; Echocardiography
• Additional relevant MeSH terms: Heart Failure; Cardiomyopathies; Amyloidosis

Study Results

No Results Posted as of Jun 9, 2023