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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00894387
Other study ID # CSPP100A2368
Secondary ID 2009-010236-18
Status Completed
Phase Phase 3
First received May 5, 2009
Last updated October 15, 2013
Start date May 2009
Est. completion date August 2012

Study information

Verified date October 2013
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 1639
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Aliskiren
Aliskiren 150 mg and Aliskiren 300 mg
Placebo
Placebo

Locations

Country Name City State
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Buenos aires
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Cordoba
Argentina Novartis Investigative Site Cordoba
Argentina Novartis Investigative Site Corrientes
Argentina Novartis Investigative Site Corrientes
Argentina Novartis Investigative Site Corrientes
Argentina Novartis Investigative Site Posadas Misiones
Argentina Novartis Investigative Site Quilmes
Argentina Novartis Investigative Site Rosario Santa Fe
Argentina Novartis Investigative Site Rosario Santa Fe
Argentina Novartis Investigative Site San Miguel de Tucuman Tucuman
Argentina Novartis Investigative Site San Nicolas Buenos Aires
Argentina Novartis Investigative Site Santa Fe
Argentina Novartis Investigative Site Santa Fe
Argentina Novartis Investigative Site Tucuman
Belgium Novartis Investigative Site Antwerpen
Belgium Novartis Investigative Site Brasschaat
Belgium Novartis Investigative Site Genk
Belgium Novartis Investigative Site Gent
Belgium Novartis Investigative Site Hasselt
Belgium Novartis Investigative Site Huy
Belgium Novartis Investigative Site Leuven
Belgium Novartis Investigative Site Mechelen
Belgium Novartis Investigative Site Mol
Belgium Novartis Investigative Site Namur
Brazil Novartis Investigative Site Belo Horizonte MG
Brazil Novartis Investigative Site Belo Horizonte MG
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Brazil Novartis Investigative Site Campinas SP
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Brazil Novartis Investigative Site Porto Alegre RS
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Brazil Novartis Investigative Site Sao Jose do Rio Preto SP
Brazil Novartis Investigative Site São Paulo SP
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Canada Novartis Investigative Site Montreal Quebec
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Poland Novartis Investigative Site Zabrze
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Romania Novartis Investigative Site Bucharest
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Romania Novartis Investigative Site Bucuresti District 1
Romania Novartis Investigative Site Craiova
Romania Novartis Investigative Site Timisoara
Romania Novartis Investigative Site Tirgoviste
Russian Federation Novartis Investigative Site Lubertsi
Russian Federation Novartis Investigative Site Moscow
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Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Nizhnii Novgorod
Russian Federation Novartis Investigative Site S.-Petersburg
Russian Federation Novartis Investigative Site S.-Petersburg
Russian Federation Novartis Investigative Site S.-Petersburg
Russian Federation Novartis Investigative Site S.-Petersburg
Russian Federation Novartis Investigative Site Saint Petersburg
Russian Federation Novartis Investigative Site Saint Petersburg
Russian Federation Novartis Investigative Site Saint-Petersburg
Russian Federation Novartis Investigative Site Saint-Petersburg
Russian Federation Novartis Investigative Site Saint-Petersburg
Russian Federation Novartis Investigative Site Sankt-Peterburg
Russian Federation Novartis Investigative Site Saratov
Russian Federation Novartis Investigative Site Saratov
Russian Federation Novartis Investigative Site St.Petersburg
Russian Federation Novartis Investigative Site Yaroslavl
Singapore Novartis Investigative Site Singapore
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Spain Novartis Investigative Site Madrid
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Taiwan Novartis Investigative Site Keelung City
Taiwan Novartis Investigative Site Lin-Ko
Taiwan Novartis Investigative Site Taichung
Taiwan Novartis Investigative Site Taipei
Taiwan Novartis Investigative Site Taipei
Turkey Novartis Investigative Site Ankara
Turkey Novartis Investigative Site Atakum / Samsun
Turkey Novartis Investigative Site Etlik / Ankara
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Turkey Novartis Investigative Site Izmir
Turkey Novartis Investigative Site Izmir
Turkey Novartis Investigative Site Kirikkale
Turkey Novartis Investigative Site Kocaeli
Turkey Novartis Investigative Site Sivas
Turkey Novartis Investigative Site Talas / Kayseri
United States Novartis Investigative Site Bronx New York
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United States Novartis Investigative Site Lafayette Louisiana
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United States Novartis Investigative Site Macon Georgia
United States Novartis Investigative Site Mobile Alabama
United States Novartis Investigative Site Newark New Jersey
United States Novartis Investigative Site Oakbrook Terrace Illinois
United States Novartis Investigative Site Philadelphia Pennsylvania
United States Novartis Investigative Site Philadelphia Pennsylvania
United States Novartis Investigative Site Pittsburgh Pennsylvania
United States Novartis Investigative Site Rapid City South Dakota
United States Novartis Investigative Site Richmond Virginia
United States Novartis Investigative Site Richmond Virginia
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site Saratoga Springs New York
United States Novartis Investigative Site Springfield Tennessee
United States Novartis Investigative Site St. Louis Missouri
United States Novartis Investigative Site Sylmar California
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United States Novartis Investigative Site Tucson Arizona
United States Novartis Investigative Site Washington District of Columbia
United States Novartis Investigative Site Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  Colombia,  Czech Republic,  Finland,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Philippines,  Poland,  Romania,  Russian Federation,  Singapore,  Slovakia,  Spain,  Sweden,  Taiwan,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization). The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months. 6 months No
Secondary Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 12 months of randomization was the key secondary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 395 (394 days from randomization). The secondary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 12 months. 12 months No
Secondary Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months Symptom reduction and reduction in physical limitations was assessed using the clinical summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a self-administered questionnaire and contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Health-Related Quality of Life (QoL), including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Each scale score was calculated as the mean of its item scores and transformed to a 0-100 scale, with higher score indicating higher level of functioning. A score of 100 represents perfect health whereas a score of 0 represents death. A positive change in score from baseline indicates an improvement. Baseline, 1 months, 6 months and 12 months No
Secondary Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation. 6 months No
Secondary Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months 12 months No
Secondary Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months The reported Least square means, and Confidential Interval were from a repeated measures model on log transformed NT-proBNP data containing treatment, visit, and region as factors, log baseline NT-proBNP as a continuous covariate and treatment by visit and visit by log baseline NT-proBNP as interaction terms. Baseline, 1 month, 6 months and 12 months No
Secondary Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation. 12 months No
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