Trial Search Results

Comparison of Saocubitril/valsartaN Versus Enalapril on Effect on ntpRo-bnp in Patients Stabilized From an Acute Heart Failure Episode.

The purpose of this study is to assess the effect of in-hospital initiation of sacubitril/valsartan (LCZ696) vs. enalapril on time averaged proportional change in NT-proBNP in patients who have been stabilized following hospitalization for acute decompensated heart failure (ADHF) and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤ 40%).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: sacubitril/valsartan (LCZ696)
  • Drug: Enalapril
  • Drug: sacubitril/valsartan (LCZ696) matching placebo
  • Drug: enalapril matching placebo

Phase:

Phase 4

Eligibility


Key Inclusion Criteria:

   1. Possess the capacity to provide written informed consent which must be obtained before
   any assessment is performed.

   2. 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.

   3. 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

   4. 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%.

   5. Elevated NT-proBNP ≥ 1600pg/mL OR BNP ≥400 pg/mL during current hospitalization.

Key Exclusion Criteria:

   1. Currently taking sacubitril/valsartan tablets or any use within the past 30 days.

   2. Enrollment in any other clinical trial involving an investigational agent or
   investigational device.

   3. History of hypersensitivity, known or suspected contraindications, or intolerance to
   any of the study drugs, including ACEIs, ARBs, or Sacubitril (NEP inhibitor).

   4. Patients with a known history of angioedema related to previous ACE inhibitor or ARB
   therapy.

   5. Requirement of treatment with both ACE inhibitor and ARB.

   6. eGFR < 30 ml/min/1.73 m2 as measured by the simplified Modification of Diet in Renal
   Disease (MDRD) formula at screening.

   7. Serum potassium > 5.2 mEq/L at screening.

   8. Known hepatic impairment (as evidenced by total bilirubin > 3 mg/dL, or increased
   ammonia levels, if performed), or history of cirrhosis with evidence of portal
   hypertension such as varices

   9. Acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid or other
   major CV surgery; percutaneous coronary intervention (PCI) or carotid angioplasty,
   within one month prior to Visit 1.

10. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
   female after conception and until the termination of gestation, confirmed by a
   positive hCG laboratory test.

11. Women of child-bearing potential, defined as all women physiologically capable of
   becoming pregnant, including women whose career, lifestyle, or sexual orientation
   precludes intercourse with a male partner and women whose partners have been
   sterilized by vasectomy or other means, UNLESS they are using two birth control
   methods.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting