Clareo Health | Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient hospitalized with a primary diagnosis of worsening heart failure ≥ 18 years of age, male or female.
Patients with a diagnosis of acute heart failure expressed by symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization.
* LVEF \< 40% (measured within the last 6 months).
* Hospitalization for ADHF and remain "stabilized" for at least 6 hours (defined as SBP ≥ 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization.
Elevated BNP at Visit 1 or at randomization (BNP ≥ 400 pg/ml).
Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization (NYHA Class II - IV).
You may not be if
Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization.
Concomitant use of ACEI and ARB at randomization.
Right heart failure due to pulmonary disease.
Diagnosis of postpartum cardiomyopathy.
Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months.
Patients with a history of heart transplant or who are on a transplant list.
Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization.
