Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients with Chronic Heart Failure with Reduced Ejection Fraction

Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients with Chronic Heart Failure with Reduced Ejection Fraction - DAPA HF

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45523

Enrollment

100

Registered

2016-12-20

Start date

2017-03-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hartfailure reduced ejection fraction

Interventions

Patients will use either dapagliflozin 10 mg or placebo once daily in addition to their standard of care hart failure medication.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Provision of signed informed consent prior to any study specific procedures 2. Male or female, aged *18 years at the time of consent 3. Established documented diagnosis of symptomatic HFrEF 4. LVEF*40% within the last 12 months prior to enrolment (Visit 1) 5. NT-proBNP >600 pg/ml 6. Patients should receive background standard of care for HFrEF 7. eGFR *30 ml/min/1.73 m2 at visit 1

Exclusion criteria

Exclusion criteria: 1. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor 2. Type 1 diabetes mellitus (T1D) 3. Symptomatic hypotension or systolic BP

Design outcomes

Primary

Measure	Time frame
The main objective of the study is to investigate whether dapagliflozin, compared with placebo, reduces the incidence of CV death or hospitalization for HF or equivalent event (ie an urgent HF visit) when added to background standard of care treatment.	—

Secondary

Measure	Time frame
The rationale for including CV death or hospitalization for HF, but excluding non-hospitalized urgent HF visits, is that this is the more conventional composite HF endpoint, may be regarded as including harder outcomes and will allow direct comparison with other HF trials. The rationale for including total number of hospitalizations (including re-hospitalizations) for HF is to capture the impact of recurrent non-fatal HF hospitalizations. Taken together with CV death, these events give a better estimate of the full burden of HF on patients and healthcare systems than time-to-first event analysis. The rationale for the secondary renal composite EP is that renal dysfunction is very common in heart failure, may lead to discontinuation of disease-modifying therapies and is associated with poor outcomes. All-cause mortality will be assessed as a secondary endpoint because it is important to evaluate the effect of dapagliflozin on non-cardiovascular, as well as cardiovascular, mortality and hence overall mortality.	—

Measure

Time frame

The rationale for including CV death or hospitalization for HF, but excluding non-hospitalized urgent HF visits, is that this is the more conventional composite HF endpoint, may be regarded as including *harder* outcomes and will allow direct comparison with other HF trials. The rationale for including total number of hospitalizations (including re-hospitalizations) for HF is to capture the impact of recurrent non-fatal HF hospitalizations. Taken together with CV death, these events give a better estimate of the full burden of HF on patients and healthcare systems than time-to-first event analysis. The rationale for the secondary renal composite EP is that renal dysfunction is very common in heart failure, may lead to discontinuation of disease-modifying therapies and is associated with poor outcomes. All-cause mortality will be assessed as a secondary endpoint because it is important to evaluate the effect of dapagliflozin on non-cardiovascular, as well as cardiovascular, mortality and hence overall mortality.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)