transthyretin cardiac amyloidosis
Conditions
Interventions
Trade Name: DILFLUNISAL
Pharmaceutical Form: Tablet
INN or Proposed INN: DIFLUNISAL
CAS Number: 22494-42-4
Concentration unit: mg millig
Sponsors
FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients over 18 years old 2. Diagnosed of cardiac amyloidosis by TTR by cardiac uptake grade 2 or 3 in a scintigraphy performed with Tc-DPD in the absence of monoclonal scintigraphy or by myocardial biopsy with positive immunofixation in the case of presenting peripheral blood gamma pathia. 3. Acceptance and signing of consent for the study after receiving the appropriate information. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Known allergy or hypersensitivity to diflunisal or any of its components, or to drugs from the group of non-steroidal anti-inflammatory drugs. 2. History of acute episodes of asthma, hives, rhinitis or angioedema in relation to ibuprofen, aspirin or other NSAIDs. 3. History or active episode of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs. 4. Severe heart failure (NYHA functional class IV) 5. Severe renal impairment: Glomerular filtration estimated <30mL / min / 1.73 m2 calculated by the CKD-EPI formula. 6. Survival <1 year due to some known comorbidity 7. Concomintant treatment with 2 antiplatelet agents associated with 1 anticoagulant 8. Previous liver or heart transplantation 9. Hepatic dysfunction (ALT / AST or BT above 3 times the upper limit of normal) 10. Platelets <100,000 / mm3 11. Potentially fertile women who are not willing to use a contraceptive method that is considered effective 12. Pregnancy or breastfeeding 13. Participants in another clinical trial with medication in the 28 days prior to the start of recruitment. 14. At the discretion of the investigator, the patient's inability to understand or comply with the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the morphological, biochemical and functional repercussions of Diflunisal treatment in patients with transthyretin cardiac amyloidosis.;Secondary Objective: To assess the safety and tolerability of Dflunisal 250mg / 12 hours for 1 year.;Primary end point(s): The primary analysis of the study will be the change in extracellular volume (CVD) measured by magnetic resonance using a T1 mapping technique before and after contrast at baseline and at 12 months of treatment.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): o Ejection fraction. o Ventricular thicknesses. o Necrotic / fibrotic area, defined as late Gadolinium uptake (high intensity STIR signals). o Functional class determined by the 6-minute walk test. o Score of the Kansas City Cardiomyopathy Questionnaire NT-proBNP levels. o High sensitivity C-reactive protein levels o High sensitivity Troponin levels o Serum TTR concentration o Proportion and description of Adverse Events. o Proportion of adherence to treatment. o Incidence of heart failure, death, or any acute coronary syndrome (IAMCEST or Acute coronary syndrome without ST elevation). ;Timepoint(s) of evaluation of this end point: 3, 6 and 9 months | — |
Countries
Spain
Contacts
Public ContactUNIDAD DE INVESTIGACION CLINICA
FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
Outcome results
None listed