Ignite Creation Date:
2024-05-06 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05981092
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2023-06-14
Brief Title:
A Study About the Natural History in Adults With BAG3 Dilated Cardiomyopathy a Type of Heart Disease BAG3 DCM
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PROSPECTIVE MULTINATIONAL STUDY OF THE NATURAL HISTORY OF PARTICIPANTS WITH BAG3 MUTATION ASSOCIATED DILATED CARDIOMYOPATHY
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAG3 DCM
Brief Summary:
The purpose of this study is to learn about the natural progression of DCM dilated cardiomyopathy caused by BAG3 gene mutations DCM is a condition as the heart muscle is weakened and the heart becomes enlarged This makes it hard for the heart to pump enough blood for the body
The study is seeking up to about 35 participants who have
BAG3 mutation change in the gene that causes or is likely to cause dilated cardiomyopathy
NYHA New York Heart Association Class I-IV at screening Stage B-D
Left Ventricular Ejection Fraction less than or equal to 50 meaning reduced heart function
All participants in this study will receive their usual treatment The investigators will observe the natural progression of people who have BAG3 DCM This will help the investigators better understand the disease and aid in future research
Participants will take part in this study for one year During this time participants will visit the site at least 4 times about every 3 months Participants will undergo study procedures and give information about their health These procedures will include a physical exam cardiac magnetic resonance imaging echocardiography ECG monitoring activity monitoring cardiopulmonary exercise testing and blood tests Participants will answer questions about health and quality of life The study team will also call participants about 1 time over the phone
The study is seeking up to about 35 participants who have
BAG3 mutation change in the gene that causes or is likely to cause dilated cardiomyopathy
NYHA New York Heart Association Class I-IV at screening Stage B-D
Left Ventricular Ejection Fraction less than or equal to 50 meaning reduced heart function
All participants in this study will receive their usual treatment The investigators will observe the natural progression of people who have BAG3 DCM This will help the investigators better understand the disease and aid in future research
Participants will take part in this study for one year During this time participants will visit the site at least 4 times about every 3 months Participants will undergo study procedures and give information about their health These procedures will include a physical exam cardiac magnetic resonance imaging echocardiography ECG monitoring activity monitoring cardiopulmonary exercise testing and blood tests Participants will answer questions about health and quality of life The study team will also call participants about 1 time over the phone
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-000398-20 | EUDRACT_NUMBER | None | None |