Treatment with doxycycline and tauroursodeoxycholic acid (Doxy/TUDCA) plus standard supportive therapy in cardiac amyloidosis caused by transthyreti

Phase 1

• Conditions: Cardiac amyloidosis caused by transthyretin; MedDRA version: 20.0Level: PTClassification code 10007509Term: Cardiac amyloidosisSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-001621-41-IT
• Lead Sponsor: FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

- Diagnosis of ATTRwt amyloidosis, or ATTRm p.Ile68Leu and p.Val122Ile;
- 18 years or older;
- cardiac involvement (mean left ventricular wall thickness >12 mm in the absence of other causes);
- history of occurrence of at least 1 event of symptomatic heart failure;
- stable diuretic dosage for at least 2 weeks before treatment initiation;
- agree to practice effective methods of contraception where necessary
- voluntary written consent
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 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 66

Exclusion Criteria

- Non-ATTR amyloidosis
- pregnant or nursing women
- uncontrolled bacterial, viral, fungal, HIV, HBV, or HCV infection;
- presence of other active malignancy with
- known allergy to tetracycline;
- treatment with drugs potentially affecting doxycycline absorption
- significant acute gastrointestinal symptoms;
- active peptic ulceration and/or esophageal reflux disease

Study & Design

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