The Effect of Trimetazidine on Cardiac Function in Patients with Cardiac Amyloidosis.

Phase 1

• Conditions: Wild-Type Transthyretin Cardiac Amyloidosis; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-001617-21-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-14
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

-Age = 60 years for men. Age = 70 years for women
-TC99-DPD-scintigraphy positive for cardiac involvement (Perugini II-III)
-Negative serum immunofixation
-Normal Kappa/Lambda ratio
-Gillmore stage I (NT-proBNP = 3000 ng/L, eGFR = 45 mL/min)
-NYHA-class I-IIa
-Informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

-Already known, similar diagnosis
oHereditary Transthyretin Cardiac Amyloidosis (ATTRh)
oLight Chain Amyloidosis (AL Amyloidosis)
oMonoclonal Gammopathy of Unspecified Significance (MGUS)
oMyelomatosis
oMb. Waldenstrøm
-Medical treatment with loop diuretics
-Contraindications to TMZ (Allergic reaction, Parkinson’s Disease, Tremor, Restless Leg Syndrome, eGFR < 30 mL/min)
-Contraindications to TC99-DPD-skintigraphy (allergic reaction to contrast)
-Significant co-morbidity assessed by the investigator
-Patients for whom informed consent cannot be collected (mental illness, dementia)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified