Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure

Conditions

• Chronic Heart Failure With Reduced Systolic Function

Eligibility Criteria

Sex

ALL

Age

19 Years - 119 Years

Healthy Volunteers

Not accepted

Interventions

• Dapagliflozin — DRUG
• Dapagliflozin matching placebo — DRUG

Study Details

The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and quality of life in patients with chronic heart failure with reduced systolic function.

Key Dates

Start date

Mar 3, 2016

Status verified

Mar 2022

Primary completion

Jun 28, 2019

Completion

Jun 28, 2019

Study Design

Enrollment

263 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Dapagliflozin
  Dapagliflozin 10 mg daily
• Placebo Comparator: Dapagliflozin matching placebo
  Dapagliflozin matching placebo 10 mg daily

Primary Outcome Measure

Difference in the Average of the 6- and 12-week Mean N-terminal Pro B-type Natriuretic Peptide (NTproBNP). [ Time Frame: Average of Week 6 and Week 12 ]

Locations (25)

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