Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04575675
Status:
COMPLETED
Last Update Posted:
2021-08-02
First Post:
2020-08-26
Brief Title:
Dapagliflozin on Hypotensive Heart Failure Patients After SacubitrilValsartan Therapy
Sponsor:
Cheng-Hsin General Hospital
Organization:
Cheng-Hsin General Hospital
Study Overview
Official Title:
Effects of Dapagliflozin on Hypotensive Patients With Depressed Left Ventricular Ejection Fraction After SacubitrilValsartan Therapy
Status:
COMPLETED
Status Verified Date:
2021-07
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:
The DAPA-HF trial demonstrated that dapagliflozin was able to reduce the risk of worsening heart failure events and cardiovascular death comparing to placebo in patients with reduced ejection fraction further to standard of care However hypotensive patients who generally have higher risks comparing to normotensive patients were under represented in the DAPA-HF The investigators aimed to evaluate clinical effects of dapagliflozin on hypotensive heart failure patients receiving chronic sacubitrilvalsartan treatment
Detailed Description:
The DAPA-HF trial demonstrated that dapagliflozin was able to reduce the risk of worsening heart failure HF events and cardiovascular death comparing to placebo in patients with reduced ejection fraction further to standard of care However hypotensive patients who generally have higher risks comparing to normotensive patients were under represented in the DAPA-HF The investigators aimed to evaluate clinical effects of dapagliflozin on hypotensive HFrEF patients receiving chronic sacubitrilvalsartan SalVal treatment
This is an investigator-initiated interventional prospective open-label study The inclusion criteria were 1 chronic symptomatic HF with New York Heart Association NYHA class II-IV and LVEF less than 40 2 treatment with stable and maximal tolerable dose of SacVal beta-blocker with or without mineralocorticoid receptor antagonist MRA 3 6-minute walking-distance 6MWD 100meters and 425 meters at enrollment 4 systolic blood pressure 100 mmHg at enrollment The exclusion criteria were 1 type 1 diabetes mellitus 2 patients previously treated with any sodium glucose co-transporter 2 inhibitor SGLT2i
After applying the inclusion and exclusion criteria if the participants had type 2 diabetes mellitus the participants will receive dapagliflozin 10mg daily directly If the participants did not have history of diabetes mellitus the participants will be allocated to either receiving dapagliflozin 10mg daily or receiving standard heart failure treatment without dapagliflozin
Vital signs and laboratory tests were examined at baseline 2-week 4-week and 12-week Six-minute-walking-test five-level EuroQol five dimensions EQ-5D-5L questionnaire and visual analogue scale VAS were collected at baseline and at 12-week
This is an investigator-initiated interventional prospective open-label study The inclusion criteria were 1 chronic symptomatic HF with New York Heart Association NYHA class II-IV and LVEF less than 40 2 treatment with stable and maximal tolerable dose of SacVal beta-blocker with or without mineralocorticoid receptor antagonist MRA 3 6-minute walking-distance 6MWD 100meters and 425 meters at enrollment 4 systolic blood pressure 100 mmHg at enrollment The exclusion criteria were 1 type 1 diabetes mellitus 2 patients previously treated with any sodium glucose co-transporter 2 inhibitor SGLT2i
After applying the inclusion and exclusion criteria if the participants had type 2 diabetes mellitus the participants will receive dapagliflozin 10mg daily directly If the participants did not have history of diabetes mellitus the participants will be allocated to either receiving dapagliflozin 10mg daily or receiving standard heart failure treatment without dapagliflozin
Vital signs and laboratory tests were examined at baseline 2-week 4-week and 12-week Six-minute-walking-test five-level EuroQol five dimensions EQ-5D-5L questionnaire and visual analogue scale VAS were collected at baseline and at 12-week
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?:
False
Is an FDA AA801 Violation?:
None