Doxycycline and TUDCA in Patients With Transthyretin Amyloid Cardiomyopathy
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|ClinicalTrials.gov Identifier: NCT01855360|
Recruitment Status : Completed
First Posted : May 16, 2013
Results First Posted : December 4, 2020
Last Update Posted : December 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Amyloidosis; Heart (Manifestation) Senile Cardiac Amyloidosis||Drug: Tauroursodeoxycholic Acid and Doxycycline||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Actual Study Start Date :||June 2013|
|Actual Primary Completion Date :||May 31, 2015|
|Actual Study Completion Date :||May 31, 2015|
Experimental: TUDCA and Doxycycline
INTERVENTION: Patients meeting study criteria were prescribed TUDCA taken orally, 250 mg three times daily. and doxycycline taken orally, 100 mg twice daily.
Drug: Tauroursodeoxycholic Acid and Doxycycline
Other Name: Doxycycline:Vibramycin, Monodox, Acticlate, Atridox, Avidoxy, Doxy, Doxycin, Doryx, Oracea, Periostat, Adoxa, Ocudox, and Doryx MPC.
- Changes in Strain Echocardiography [ Time Frame: 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.
- Number of Patients With Adverse Events [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855360
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Rodney H Falk, MD||Brigham and Women's Hospital, Boston MA|