Clinical Study of ATTR-CM
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04935021
Collaborator
(none)
100
1
1
120
0.8
Study Details
Study Description
Brief Summary
In this study, patients with ATTR-CM or gene carriers were selected to study the diagnosis and treatment, and long-term follow-up was conducted.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study Protocol of Transthyroxine Protein Amyloidosis Cardiomyopathy and Its Gene Carriers
Anticipated Study Start Date
:
Jul 1, 2021
Anticipated Primary Completion Date
:
Jul 1, 2031
Anticipated Study Completion Date
:
Jul 1, 2031
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ATTR-CM Patients or Gene carrier |
Drug: ATTR-CM
Current treatment
|
Outcome Measures
Primary Outcome Measures
- Rate of cardiovascular death, myocardial infarction, and stroke [10 year]
Primary Outcome
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients and gene carriers of ATTR-CM confirmed in the Second Affiliated Hospital of Zhejiang University School of Medicine, regardless of gender, age 18-90 years old;
-
Patients who have the ability to understand the test and can cooperate with investigators
Exclusion Criteria:
- Patients who unable to understand or unwilling to fill in informed consent forms or follow visitors
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | xiaohong University PAN | Hangzhou | Zhejiang | China |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04935021
Other Study ID Numbers:
- 2021-0132
First Posted:
Jun 22, 2021
Last Update Posted:
Jun 22, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: