"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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00219011
• Collaborator: (none)
• Enrollment: 280
• Locations: 2
• Duration (Months): 21.1
• Patients Per Site: 140
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: aliskiren	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Other
• 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
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: Feb 1, 2007
• Actual Study Completion Date: Feb 1, 2007

Outcome Measures

Primary Outcome Measures

1. Measurement of safety information and tolerability of drug after 12 weeks []

Secondary Outcome Measures

1. 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 []

2. 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 []

3. Changes in New York Heart Association heart failure stages after 12 weeks []

4. Changes from baseline in the forces of the circulation of blood as measured by echocardiography to after 12 weeks []

5. Change from baseline in mean sitting systolic and diastolic blood pressure after 12 weeks []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Novartis Pharmaceuticals	East Hanover	New Jersey	United States
2		Investigative Centers		Germany

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00219011
• Other Study ID Numbers: CSPP100A2313
• First Posted: Sep 22, 2005
• Last Update Posted: May 17, 2017
• Last Verified: May 1, 2017

• Keywords provided by Novartis: Aliskiren, heart failure,hypertension
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of May 17, 2017