EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)
- Registration Number
- NCT03057951
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This is a study in adults with chronic heart failure. People with chronic heart failure may need to be hospitalised for their condition. Some people with chronic heart failure may eventually die from their condition. The purpose of the study is to find out whether a medicine called empagliflozin lowers the chances of patients having to go to hospital for heart failure and whether it improves their survival. The study is open to patients with a type of chronic heart failure called chronic heart failure with preserved ejection fraction.
Participants stay in the study until researchers have enough information about how effective empagliflozin is. It is expected that participants who enter at the very beginning of the enrolment period may be in the study for over 3 years, while participants who enter near the end of the enrolment period may be in the study for less than 2 years. The participants are put into 2 groups. It is decided by chance who gets into which group. One group gets empagliflozin tablets every day and the other group gets placebo tablets every day. Placebo tablets look like empagliflozin tablets but contain no medicine.
Participants visit the doctors regularly. During these visits, the doctors collect information about the participant's health. The doctors want to know how many patients had to go to hospital because of heart failure or who died from cardiovascular disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5988
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - 10 mg Empagliflozin Empagliflozin -
- Primary Outcome Measures
Name Time Method Time to First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) From randomization until completion of the planned treatment phase, up to 1403 days. Failure with preserved Ejection Fraction (HFpEF). The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:
Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\].
Time at risk \[years\] = Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.
- Secondary Outcome Measures
Name Time Method Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent) From randomization until completion of the planned treatment phase, up to 1403 days. Reported is the total number of adjudicated HHF events (first and recurrent) which occurred.
Change From Baseline in Kansas City Cardiomyopathy Questionaire (KCCQ) Clinical Summary Score at Week 52 At baseline and at week 12, week 32 and week 52. The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, self-efficacy, and quality of life in patients with Heart Failure. The KCCQ-clinical summary score comprises the following domains: Symptom frequency, symptom burden and physical limitation. The score is calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.
For patients who died, a worst score (score of 0) was imputed for the score at all subsequent scheduled visits after the date of death where the score would have been assessed.
Change from baseline in KCCQ-score at week 52 was modeled using a MMRM with visit (week 12, 32 and 52) as repeated measures, adjusted mean (standard error) at week 52 is reported.Occurrence of All-cause Hospitalisation (First and Recurrent) From randomization until completion of the planned treatment phase, up to 1403 days. Occurrence of all-cause hospitalisation (first and recurrent). Total number of all cause hospitalisations is reported.
eGFR (CKD-EPI) cr Slope of Change From Baseline At baseline, week 4, 12, 32, 52, 76, 100, 124, 148, 172 and week 196, up to 1043 days. Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR(CKD-EPI)cr) slope of change from baseline.
Available on-treatment change-from-baseline data were used. The slope represents the long term effect of eGFR change from baseline and provides the yearly rate of decline.
Timepoints after baseline were included in calculation of slope of change from baseline.
The slope per patient was calculated using a random coefficient model with terms for treatment, region, baseline status of diabetes, age, sex, left ventricular ejection fraction (LVEF) and glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)cr) at baseline and in addition the factors "time", "treatment-by-time interaction", and "baseline eGFR (CKD-EPI)cr-by-time interaction".Time to the First Event in the Composite Renal Endpoint: Chronic Dialysis, Renal Transplant, or Sustained Reduction in eGFR (CKD-EPI)cr From randomization until completion of the planned treatment phase, up to 1403 days. Chronic dialysis was defined as dialysis with a frequency of twice per week or more for at least 90 days.
Sustained was determined by two or more consecutive post-baseline central laboratory measurement separated by at least 30 days.
Reduction in glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) was defined as reduction in eGFR from baseline ≥40%, eGFR \<15 mL/min/1.73 m\^2 for patients with baseline eGFR ≥30 mL/min/1.73 m\^2, or eGFR \<10 mL/min/1.73 m\^2 for patients with baseline eGFR \<30 mL/min/1.73 m\^2.
The incidence rate per 100 patient years (100 \* number of patients with event / time at risk \[years\]) is reported. Time at risk \[year\] is calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Abbreviation:
Patient-years (pt-yrs).Time to First Adjudicated Hospitalisation for Heart Failure (HHF) From randomization until completion of the planned treatment phase, up to 1403 days. Time to first adjudicated HHF. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:
Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\].
Time at risk \[years\] = Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.Time to Adjudicated Cardiovascular (CV) Death From randomization until completion of the planned treatment phase, up to 1403 days. Time to adjudicated CV death. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:
Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\].
Time at risk \[years\] = Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.Time to All-cause Mortality From randomization until completion of the planned treatment phase, up to 1403 days. Time to all-cause mortality. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:
Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\].
Time at risk \[years\] = Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.Time to Onset of Diabetes Mellitus (DM) in Patients With Pre-DM From randomization until completion of the planned treatment phase, to 1403 days. Time to onset of DM (defined as HbA1c ≥6.5% or as diagnosed by the investigator) in patients with pre-DM.
Pre-DM was defined as no history of DM and no HbA1c ≥6.5% before treatment, and a pre-treatment HbA1c value of ≥5.7% and \<6.5%.
The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:
Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\].
Time at risk \[years\] = Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.
Trial Locations
- Locations (610)
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Heart Center Research, LLC
🇺🇸Huntsville, Alabama, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
La Mesa Cardiac Center
🇺🇸La Mesa, California, United States
Purushotham, Akther & Roshan Kotha, MD Inc.
🇺🇸La Mesa, California, United States
Long Beach Center for Clinical Research
🇺🇸Long Beach, California, United States
VA Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
Merced Vein and Vascular Center
🇺🇸Merced, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Scroll for more (600 remaining)Pinnacle Research Group, LLC🇺🇸Anniston, Alabama, United States