Back to resultsClinical Study of ATTR-CM
Primary Purpose
Transthyroxine Amyloidosis Cardiomyopathy
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
ATTR-CM
Sponsored by
About this trial
This is an interventional treatment trial for Transthyroxine Amyloidosis Cardiomyopathy
Eligibility Criteria
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
Sites / Locations
- xiaohong University PANRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ATTR-CM
Arm Description
Patients or Gene carrier
Outcomes
Primary Outcome Measures
Rate of cardiovascular death, myocardial infarction, and stroke
Primary Outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT04935021
First Posted
June 20, 2021
Last Updated
January 29, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04935021
Brief Title
Clinical Study of ATTR-CM
Official Title
Clinical Study Protocol of Transthyroxine Protein Amyloidosis Cardiomyopathy and Its Gene Carriers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 1, 2031 (Anticipated)
Study Completion Date
June 1, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transthyroxine Amyloidosis Cardiomyopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ATTR-CM
Arm Type
Experimental
Arm Description
Patients or Gene carrier
Intervention Type
Drug
Intervention Name(s)
ATTR-CM
Intervention Description
Current treatment
Primary Outcome Measure Information:
Title
Rate of cardiovascular death, myocardial infarction, and stroke
Description
Primary Outcome
Time Frame
10 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
xiaohong University PAN
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaohong U PAN
Phone
+8613857116993
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Study of ATTR-CM
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