Status:
COMPLETED
Doxycycline and TUDCA in Patients With Transthyretin Amyloid Cardiomyopathy
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Amyloidosis; Heart (Manifestation)
Senile Cardiac Amyloidosis
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
PHASE2
Brief Summary
The objective of the study is to determine whether the combination of the bile acid TUDCA, and doxycycline will slow the progression of familial and senile amyloidosis.
Detailed Description
Primary objectives The study is designed to prospectively evaluate the efficacy of doxycycline and TUDCA, prescribed together, on cardiac disease progression in patients with senile systemic amyloidos...
Eligibility Criteria
Inclusion
- Documented transthyretin cardiac amyloidosis by biopsy and staining using immunohistochemistry or mass spectrometry
- Echocardiographic appearance of left ventricular wall thickness of 13mm or more in the absence of hypertensive heart disease
- Confirmed ATTR or SSA by genetic testing
- Age 18-90
- Male or non-pregnant, non-lactating females
- Willingness to return to the treatment center for follow-up
Exclusion
- Prior liver transplantation or liver transplantation anticipated in less than 6 months
- Alanine Transaminase and/or Aspartate Transaminase ≥2 x upper normal limit (UNL)
- Alkaline Phosphatase ≥2 x UNL
- Creatinine clearance \<20 mL/min
- Any other lab values that in the opinion of the investigator might place the subject at unacceptable risk for participation in the study
- History of poor compliance
- History of hypersensitivity to any of the ingredients of the study therapies
- Any investigational drug within 4 weeks prior to study entry or during the study
- Current use of diflunisal for therapy of amyloidosis
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01855360
Start Date
June 1 2013
End Date
May 31 2015
Last Update
December 4 2020
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115