Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - Any
Updated:4/3/2019
Start Date:August 27, 2018
End Date:June 22, 2021
Contact:AstraZeneca Clinical Study Information Center
Email:information.center@astrazeneca.com
Phone:1-877-240-9479

Use our guide to learn which trials are right for you!

An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)

This is an international, multicentre, parallel-group, event-driven, randomised,
double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of
dapagliflozin 10 mg versus placebo, given once daily in addition to background regional
standard of care therapy, including treatments to control co-morbidities, in reducing the
composite of CV death or heart failure events.

This is an international, multicentre, parallel-group, event-driven, randomised, double-blind
study in patients with HFpEF, evaluating the effect of dapagliflozin 10 mg versus placebo,
given once daily in addition to background regional standard of care therapy, including
treatments to control co-morbidities, in reducing the composite of CV death and heart failure
events (hospitalisations for HF or urgent HF visits). Adult patients aged ≥40 years with
HFpEF (LVEF >40% and evidence of structural heart disease) and New York Heart Association
(NYHA) class II-IV who are eligible according to the inclusion/exclusion criteria will be
randomised in a 1:1 ratio to receive either dapagliflozin 10 mg or placebo. Both out-patients
and in-patients hospitalised for heart failure and off intravenous heart failure-therapy for
24 hours can be randomised. It is estimated that approximately 8000 patients at 400-500 sites
in 20-25 countries will need to be enrolled to reach the target of approximately 4700
randomised patients.

Inclusion Criteria:

1. Provision of signed informed consent prior to any study specific procedures.

2. Male or female patients age ≥40 years.

3. Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrolment, and
a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrolment
with at least intermittent need for diuretic treatment.

4. Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart
disease (i.e. left ventricular hypertrophy or left atrial enlargement ) documented by
the most recent echocardiogram, and/or cardiac MR within the last 12 months prior to
enrolment. For patients with prior acute cardiac events or procedures that may reduce
LVEF, e.g. as defined in exclusion criterion 6, qualifying cardiac imaging assessment
at least 12 weeks following the procedure/event is required.

5. Elevated NT-pro BNP levels.

6. Both ambulatory and hospitalised patients may be enrolled and randomised. Patients
currently hospitalised for HF, must be off intravenous HF medications for at least 24
before randomisation.

Further details regarding inclusion criteria 4-6 may apply.

Exclusion Criteria:

1. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or
previous intolerance to an SGLT2 inhibitor.

2. Type 1 diabetes mellitus (T1D).

3. eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1.

4. Systolic blood pressure (BP) <95 mmHg on 2 consecutive measurements at 5-minute
intervals, at Visit 1 or at Visit 2.

5. Systolic BP≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications
or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at 5-minute
intervals, at Visit 1 or at Visit 2.

6. MI, unstable angina, coronary revascularization (percutaneous coronary intervention
(PCI) or coronary artery bypass grafting (CABG)), ablation of atrial
flutter/fibrillation, valve repair/replacement within 12 weeks prior to enrolment.
Before enrolment, these patients must have their qualifying echocardiography and/or
cardiac MRI examination at least 12 weeks after the event.

7. Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve
repair/replacement.

8. Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.

9. Probable alternative or concomitant diagnoses which in the opinion of the investigator
could account for the patient's HF symptoms and signs (e.g. anaemia, hypothyroidism).

10. Body mass index >50 kg/m2.

Further exclusion criteria may apply
We found this trial at
66
sites
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Altoona, PA
Click here to add this to my saved trials
?
mi
from
Ames, IA
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Bridgewater, NJ
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
?
mi
from
Burlington, VT
Click here to add this to my saved trials
?
mi
from
Caba,
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
?
mi
from
Flint, MI
Click here to add this to my saved trials
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
?
mi
from
Gurnee, IL
Click here to add this to my saved trials
?
mi
from
Hammond, LA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Jackson, TN
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Lansing, MI
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
?
mi
from
Leesburg, VA
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
Mentor, OH
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
Mobile, AL
Click here to add this to my saved trials
?
mi
from
Morgan City, LA
Click here to add this to my saved trials
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
?
mi
from
Naples, FL
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Ocala, FL
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
?
mi
from
Port Charlotte, FL
Click here to add this to my saved trials
?
mi
from
Providence, RI
Click here to add this to my saved trials
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
?
mi
from
Rochester, MN
Click here to add this to my saved trials
?
mi
from
Saint Augustine, FL
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Saratoga Springs, New York 12866
?
mi
from
Saratoga Springs, NY
Click here to add this to my saved trials
?
mi
from
Sheffield, AL
Click here to add this to my saved trials
?
mi
from
Sherman, TX
Click here to add this to my saved trials
?
mi
from
Stamford, CT
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Tullahoma, TN
Click here to add this to my saved trials
?
mi
from
Tupelo, MS
Click here to add this to my saved trials
?
mi
from
Warwick, RI
Click here to add this to my saved trials
Wilmington, North Carolina 28401
?
mi
from
Wilmington, NC
Click here to add this to my saved trials