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Clinical Trials List

Protocol NumberCSPP100A2368
NCT Number(ClinicalTrials.gov Identfier)NCT00894387

2009-07-01 - 2012-07-27

Phase III

Terminated5

ICD-10I50.9

Heart failure, unspecified

ICD-9428.0

Congestive heart failure

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the 6 Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality When Initiated Early After Hospitalization for Acute Decompensated Heart Failure

  • Trial Applicant

    NOVARTIS (TAIWAN) CO., LTD.

  • Sponsor

    Novartis Pharmaceuticals

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 程文俊 Division of Cardiovascular Diseases
Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

  • 王兆弘 Division of Cardiovascular Diseases
  • 楊甯貽 Division of Cardiovascular Diseases
  • 洪明銳 Division of Cardiovascular Diseases
  • 陳建光 Division of Cardiovascular Diseases
  • 郭李堂 Division of Cardiovascular Diseases
  • 李承欽 Division of Cardiovascular Diseases
  • 鄭淇文 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wen-Chung Yu Division of Cardiovascular Diseases
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chi-Tai Kuo Division of Cardiovascular Diseases
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

  • 王俊力 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Kuan-Cheng Chang Division of Cardiovascular Diseases
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator WEN-TER Lai Division of Cardiovascular Diseases
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

Condition/Disease

Acute Decompensated Heart Failure

Objectives

This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.

Test Drug

Aliskiren(SPP100)/Rasilez®

Active Ingredient

Aliskiren

Dosage Form

Tablet

Dosage

150/300

Endpoints

Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months [ Time Frame: 12 months ]
A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.

Inclution Criteria

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).

Exclusion Criteria

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.
Other protocol-defined inclusion/exclusion criteria applied.

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    1782 participants

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