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Completed

NCT Number: NCT00219011

"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 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Centers, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aliskiren

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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