"ALOFT - Aliskiren Observation of Heart Failure Treatment": Efficacy and Safety of Aliskiren Added on Top of Standard Therapy in Adults (≥ 18 Years) With Stable Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00219011
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

This study was designed to determine if patients, who have both high blood pressure and heart failure and are currently receiving drug treatment for heart failure, have an improvement in their heart failure signs and symptoms and other indicators of heart failure after being treated with aliskiren on top of their current heart failure treatment. Aliskiren is an investigational drug; its safety will also be evaluated in this trial.


Condition Intervention Phase
Heart Failure
Drug: aliskiren
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: A Twelve-week, Randomized, Double-blind, Multi-center, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Aliskiren 150 mg When Added to Standard Therapy in Hypertensive Patients With Stable Heart Failure

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measurement of safety information and tolerability of drug after 12 weeks

Secondary Outcome Measures:
  • Change from baseline in the heart failure biochemical markers of N-terminal pro-brain natriuretic peptide (NT-proBNP) and brain natriuretic (BNP) after 12 weeks
  • Change from baseline in aldosterone (a steroid hormone secreted by the adrenal cortex that regulates salt and water balance in the body) after 12 weeks
  • Changes in New York Heart Association heart failure stages after 12 weeks
  • Changes from baseline in the forces of the circulation of blood as measured by echocardiography to after 12 weeks
  • Change from baseline in mean sitting systolic and diastolic blood pressure after 12 weeks

Estimated Enrollment: 280
Study Start Date: May 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of diagnosis or currently have high blood pressure
  • Stable heart failure (NYHA Class 2-4) for at least 1 month before study entry. Subject should be on a stable dose regimen of heart failure medication.
  • Brain natriuretic peptide (BNP) > 150 pg/ml at baseline (to be evaluated by physician at first visit)

Exclusion Criteria:

  • Previous treatment with aliskiren
  • High blood pressure due to secondary reasons or constant low blood pressure (systolic < 90 mmHg)
  • History of heart attack or coronary bypass surgery in the past 6 months

Other protocol-defined exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219011

Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States
Germany
Investigative Centers, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00219011     History of Changes
Other Study ID Numbers: CSPP100A2313
Study First Received: September 12, 2005
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Aliskiren, heart failure,hypertension

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014