Trial · NCT01855360
Doxycycline and TUDCA in Patients With Transthyretin Amyloid Cardiomyopathy
NCT01855360, Phase 1, Phase 2, Completed, Brigham and Women's Hospital; results first posted 2020-12-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Doxycycline and TUDCA in Patients With Transthyretin Amyloid Cardiomyopathy. Trials, record NCT01855360. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01855360
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Doxycycline and TUDCA in Patients With Transthyretin Amyloid Cardiomyopathy
- NCT number
- NCT01855360
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Amyloidosis; Heart (Manifestation), Senile Cardiac Amyloidosis
- Interventions
- Tauroursodeoxycholic Acid and Doxycycline
- First posted
- 2013-05-16
- Last updated
- 2020-12-04
- Results first posted
- 2020-12-04
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Secondary | Number of Patients With Adverse Events | 18 months |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | Patients who completed 18 month visit (primary outcome) and had a technically adequate echocardiogram to analyze strain imaging | percent LV shortening | MEAN |
| SECONDARY | Number of Patients With Adverse Events | 18 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Strain Echocardiography | TUDCA and Doxycycline | 9.1 | Standard Deviation .9 | percent LV shortening | |
| Number of Patients With Adverse Events | TUDCA and Doxycycline | 7 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TUDCA and Doxycycline | 40 | |
| Overall Study | COMPLETED | TUDCA and Doxycycline | 30 | |
| Overall Study | NOT COMPLETED | TUDCA and Doxycycline | 10 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | gastrointestinal upset | Gastrointestinal disorders | TUDCA and Doxycycline | 6 | 40 | 6 |
| serious | acute kidney injury | Renal and urinary disorders | TUDCA and Doxycycline | 1 | 40 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TUDCA and Doxycycline | 6 | 40 |
| Total, other adverse events | TUDCA and Doxycycline | 6 | 40 |
| Total, serious adverse events | TUDCA and Doxycycline | 1 | 40 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01855360
GET https://conductscience.org/api/trials/v1/NCT01855360/registered