Immunoglobulin Light Amyloidosis CardiomyopathyNCT04924998
Clinical Study for AL-CM
An observational study of Immunoglobulin Light Amyloidosis Cardiomyopathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
In this study, patients diagnosed with Al-CM were selected to observe the effect of treatment and conduct long-term follow-up. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immunoglobulin Light Amyloidosis Cardiomyopathy
- What is being tested?
- current treatment of AL-CM
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with AL-CM
Who may be able to join
- Patients aged 18-90 years, regardless of gender, diagnosed with Al-CM at the Second Affiliated Hospital of Zhejiang University School of Medicine;
- Patients have the ability to understand the test, can cooperate with investigators.
Who cannot join
- Unable to understand or unwilling to fill in informed consent forms or follow visitors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang
xiaohong U PAN, +8613857116993
About this study
Official title: Clinical Study Protocol for the Treatment of Immunoglobulin Light Chain Amyloidosis Cardiomyopathy
In this study, patients diagnosed with Al-CM were selected to observe the effect of treatment and conduct long-term follow-up.
- Being tested
- current treatment of AL-CM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
current treatment of AL-CMDrug
current treatment of AL-CM
| Study group | Role | What they receive |
|---|---|---|
| AL-CM | Not described Receives: Drug: current treatment of AL-CM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
incidences of MACE-4(cardiovascular death, myocardial infarction, stroke and hospitalized unstable angina)
Measured: 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2031 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunoglobulin Light Amyloidosis CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924998
- Sponsor's protocol ID
- 2021-0133
- Status last verified
- Jan 2023
- First submitted
- 7 Jun 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Protocol for the Treatment of Immunoglobulin Light Chain Amyloidosis Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04924998
- Acronym / sponsor ID
- 2021-0133
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2031 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, patients diagnosed with Al-CM were selected to observe the effect of treatment and conduct long-term follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AL-CM | – | Drug: current treatment of AL-CM |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AL-CM
Key inclusion criteria (2 listed)
- Patients aged 18-90 years, regardless of gender, diagnosed with Al-CM at the Second Affiliated Hospital of Zhejiang University School of Medicine;
- Patients have the ability to understand the test, can cooperate with investigators.
Key exclusion criteria (1 listed)
- Unable to understand or unwilling to fill in informed consent forms or follow visitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| current treatment of AL-CMcurrent treatment of AL-CM | Drug | AL-CM |
Primary outcome
Primary Outcome
Time frame: 10 year
incidences of MACE-4(cardiovascular death, myocardial infarction, stroke and hospitalized unstable angina)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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Amyloidosis, Primary, Cardiomyopathy
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunoglobulin Light Amyloidosis Cardiomyopathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 10 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.