An 18 Month, Open Label Study of the Tolerability and Efficacy of a Combination of Doxycycline and Tauroursodeoxycholic Acid (TUDCA) in Patients With Transthyretin Amyloid Cardiomyopathy.

NCT01855360 Phase 1/Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Brigham and Women's Hospital
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	40
Start date	2013-06
Completion	2015-05-31

Conditions

• Amyloidosis; Heart (Manifestation)
• Senile Cardiac Amyloidosis

Interventions

• Tauroursodeoxycholic Acid and Doxycycline

Primary outcomes

• Changes in Strain Echocardiography — Time Frame: * (FDAAA) outcome measure is assessed every 6 months by serial echocardiography, with final measurement 18 months after enrollment, change at 12 months reported as pre-defined primary endpoint.
  Outcome measure, namely changes in longitudinal echocardiographic strain, will be compared to previously determined changes derived from a cohort of patients with TTR cardiac amyloidosis who were not receiving specific therapy for amyloid deposition.

Countries

United States