Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424288
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-05-10
Brief Title:
A Study to Test Whether BI 690517 in Combination With Empagliflozin Helps People With Heart Failure
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
EASi-HF - A Phase III Double-blind Randomised Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral BI 690517 and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Heart Failure HF NYHA II-IV and Left Ventricular Ejection Fraction LVEF 40
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
This study is open to adults aged 18 or above legal age with heart failure People can join the study if they have heart failure symptoms and a left ventricular ejection fraction LVEF of 40 or more The purpose of this study is to find out whether BI 690517 in combination with empagliflozin helps people with heart failure
Participants are put into 2 groups by chance Every participant has an equal chance of being in each group The groups are
BI 690517 and empagliflozin group participants take BI 690517 and empagliflozin as tablets once a day
Placebo and empagliflozin group participants take placebo and empagliflozin as tablets once a day
Participants can stay in the study as long as they benefit from treatment and can tolerate it During this time they visit their doctors regularly The doctors regularly check participants health and take note of any unwanted effects The study staff may also contact the participants by phone Participants also regularly answer questions about their well-being
The study does not have a fixed duration It continues until we have enough data to see if the treatment is working
Participants are put into 2 groups by chance Every participant has an equal chance of being in each group The groups are
BI 690517 and empagliflozin group participants take BI 690517 and empagliflozin as tablets once a day
Placebo and empagliflozin group participants take placebo and empagliflozin as tablets once a day
Participants can stay in the study as long as they benefit from treatment and can tolerate it During this time they visit their doctors regularly The doctors regularly check participants health and take note of any unwanted effects The study staff may also contact the participants by phone Participants also regularly answer questions about their well-being
The study does not have a fixed duration It continues until we have enough data to see if the treatment is working
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| 2023-509706-30-00 | REGISTRY | None | None |
| U1111-1302-4422 | REGISTRY | WHO International Clinical Trials Registry Platform ICTRP | None |