Screening, Characterization, and Longitudinal Follow-up of Patients With Cardiac Amyloidosis

NCT07577466 | Not Yet Recruiting

• 1 other identifier: Cardiac Amyloidosis
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac amyloidosis is a progressive disorder caused by extracellular deposition of amyloid fibrils in the heart, leading to heart failure and impaired cardiac function. Early diagnosis and targeted therapies are essential to improve patient outcomes. This prospective, single-center study aims to longitudinally follow patients with suspected cardiac amyloidosis to characterize disease progression and assess treatment effects. Participants will undergo cardiac magnetic resonance imaging (resting and exercise stress MRI), magnetic resonance spectroscopy, cardiopulmonary exercise testing (spiroergometry) and blood testing at baseline and at 6, 12, and 24 months

Conditions

Amyloidosis Cardiac; Heart Failure; Cardiac MRI; Spectroscopic Analysis; Diagnosis; Phenotyping

Keywords

Cardiac MRI; Exercise MRI; Magnetic Resonace Spectroscopy; Spirometry; Cardiopulmonary Exercise Testing; Disease Progression; Treatment Monitoring; Longitudinal Study

Outcome Measures

Primary Outcomes (3)

• Changes in myocardial structural parameters

  measured by Cardiac Magnetic Resonance Tomography

  after 6 and 12 months

• Changes in myocardial function

  measured by cardiac magnetic resonance

  after 6 and 12 months

• Changes in myocardial metabolism under therapy

  measured by MR spectroscopy

  after 6 and 12 months

Secondary Outcomes (1)

• Changes in heart rate reserve

  after 6 and 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Cardiac Amyloidosis

You may qualify if:

• Age \> 18 years
• Male and female patients undergoing clinically indicated diagnostic work-up for amyloidosis or with a previously confirmed diagnosis of cardiac amyloidosis prior to initiation of therapy
• Presence of left ventricular wall thickness \> 12 mm on transthoracic echocardiography and at least one "red flag" suggestive of cardiac amyloidosis (according to ESC 2021 criteria) or an otherwise clinically established suspicion of amyloidosis
• Written informed consent

You may not qualify if:

• Age \< 18 years
• Contraindications to cardiac MRI (e.g., metallic foreign bodies, older-generation pacemakers, severe obesity, claustrophobia)
• Lack of written informed consent for study participation
• Inability to comply with the study procedures

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

University Hospital Duesseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

TTR

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Heart Failure; Disease; Disease Progression

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Malte Kelm, MD

  Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf

  STUDY DIRECTOR

• Amin Polzin, MD

  Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf

  STUDY CHAIR

Central Study Contacts

Fabian Voß, MD

CONTACT

02118105187; ctu@med.uni-duesseldorf.de

Saskia Pietrucha, M.Sc.

CONTACT

ctu@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)