Heart Failure Clinical Trial
Official title:
Effects of Dapagliflozin on Hypotensive Patients With Depressed Left Ventricular Ejection Fraction After Sacubitril/Valsartan Therapy
Verified date | July 2021 |
Source | Cheng-Hsin General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 sacubitril/valsartan treatment.
Status | Completed |
Enrollment | 78 |
Est. completion date | December 30, 2020 |
Est. primary completion date | November 25, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - chronic symptomatic HF with New York Heart Association (NYHA) class II-IV and left ventricular ejection fraction (LVEF) less than 40% - treatment with stable and maximal tolerable dose of Sac/Val, beta-blocker with or without mineralocorticoid receptor antagonist - 6-minute walking-distance (6MWD)= 100meters and =425 meters at enrollment - systolic blood pressure =100 mmHg at enrollment Exclusion Criteria: - hemodialysis - severe co-morbidities with life expectancy less than 1 year - type 1 diabetes mellitus - ever treated with any type of sodium glucose cotransporter 2 inhibitor (SGLT2i) |
Country | Name | City | State |
---|---|---|---|
Taiwan | Cheng Hsin General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Cheng-Hsin General Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6-minute walking distance | Measuring walking distance within 6 minutes | 12 weeks | |
Secondary | EQ-5D-5L | Measuring health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.This version of EQ-5D has five-level scale, The number of levels of severity was classified into: having no problems, having slight problems, having moderate problems, having severe problems and being unable to do/having extreme problems. This version can define 3,125 (5x5x5x5x5) different health states.
Valuation of the EQ-5D-5L was then calcuated by the Taiwanese hybrid model, range from -1.0259 to 1. [PLoS One 13(12):e0209344]. Higher score indicates better health status. |
12 weeks | |
Secondary | EQ-Visual analogue scale (EQ-VAS) | Evaluating the participants' overall health status. The participant would be asked to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine". | 12 weeks |
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