PIONEER-HF: Sacubitril/Valsartan vs. Enalapril following Acute Decompensated Heart Failure

What we are studying

The purpose of this study is to see if starting sacubitril/valsartan while in the hospital, as compared to enalapril, will have an effect on the blood test called NT-proBNP, that reflects elevated pressures or stress on the heart, in patients that have been hospitalized for a type of heart failure where the heart is weak and cannot pump enough blood to the lungs and rest of the body.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Patients eligible for inclusion in this study have to fulfill all of the following criteria:
    • 1. Possess the capacity to provide written informed consent which must be obtained before any assessment is performed. 2. Patients ≥ 18 years of age
  • Male or female. 3. Currently hospitalized for ADHF. Patients with a diagnosis of acute heart failure had to have symptoms and signs of fluid overload (i.e. jugular venous distention
  • Edema or rales on auscultation or pulmonary congestion on chest x-ray) at time of hospitalization. 4. Eligible patients will be randomized no earlier than 24 hours and up to ten days after presentation while still hospitalized as long as meet the following definition of stable status:
    •  SBP ≥100mm Hg for the preceding 6 hours prior to randomization
    • No Symptomatic hypotension  No increase (intensification) in i.v. diuretic dose within last 6 hours prior to randomization  No i.v. inotropic drugs for 24 hours prior to randomization  No i.v. vasodilators including nitrates within last 6 hours prior to randomization 5. LVEF ≤40% within the past 6 months (including current hospitalization) using echocardiography
  • Multi gated acquisition scan (MUGA)
  • CT scanning
  • MRI or ventricular angiography
  • Provided no subsequent study documented an EF of >40%. 6. Elevated NT-proBNP ≥ 1600pg/mL OR BNP ≥400 pg/mL during current hospitalization

What is involved

  • Informed consent Medical History and Demographics Dispensation of Study Drug Nine clinic visits (CRU and inpatient) Blood pressure and heart rate measured; EKG Blood and urine samples Patient questionnaires (2)

Compensation

None

Contact Information

Study Coordinator
Alexandra Bolick
Email
abolick@wakehealth.edu
Phone
3367160484
Principal Investigator
Barbara Pisani, DO

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.