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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07577466
Enrollment
200
Registered
2026-05-11
Start date
2026-06-15
Completion date
2029-12-31
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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

Detailed description

This study is designed to longitudinally evaluate patients with cardiac amyloidosis. Patients undergoing clinically indicated diagnostic work-up for amyloidosis prior to initiation of specific therapy. Participants will undergo comprehensive baseline assessments including resting cardiac MRI, exercise stress MRI, magnetic resonance spectroscopy, pulmonary function testing, cardiopulmonary exercise testing (spiroergometry) as well as blood testing including biomarkers relevant to cardiac amyloidosis (e.g., NT-proBNP, troponin, serum free light chains, immunofixation, and other routine laboratory parameters). Patients will be seen at 3 and 9 months as part of routine clinical care. Study-specific assessments, including imaging and functional testing, will be performed at 6, 12, and 24 months. Imaging, functional and laboratory findings will be correlated with clinical characteristics, laboratory parameters, and treatment over time to improve disease characterization, monitoring, and understanding of disease progression in cardiac amyloidosis. The study aims to systematically characterize cardiac structure and function, disease phenotype, and clinical status, and to assess their evolution over time. Additional data collected within the study will not influence clinical management and are intended solely for scientific analysis. The overall objective is to improve understanding of disease progression and treatment effects through comprehensive phenotyping and follow-up in a real-world clinical setting

Interventions

None listed

Sponsors

Heinrich-Heine University, Duesseldorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Changes in myocardial structural parametersafter 6 and 12 monthsmeasured by Cardiac Magnetic Resonance Tomography
Changes in myocardial functionafter 6 and 12 monthsmeasured by cardiac magnetic resonance
Changes in myocardial metabolism under therapyafter 6 and 12 monthsmeasured by MR spectroscopy

Secondary

MeasureTime frameDescription
Changes in heart rate reserveafter 6 and 12 monthsmeasured by functional exercise testing

Countries

Germany

Contacts

CONTACTFabian Voß, MD
ctu@med.uni-duesseldorf.de02118105187
CONTACTSaskia Pietrucha, M.Sc.
ctu@med.uni-duesseldorf.de
STUDY_DIRECTORMalte Kelm, MD

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

STUDY_CHAIRAmin Polzin, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026