NCT00219011

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P50-P75 for phase_3 heart-failure

Timeline
Completed

Started May 2005

Shorter than P25 for phase_3 heart-failure

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1.8 years

First QC Date

September 12, 2005

Last Update Submit

May 15, 2017

Conditions

Heart Failure

Keywords

Aliskiren, heart failure,hypertension

Outcome Measures

Primary Outcomes (1)

  • Measurement of safety information and tolerability of drug after 12 weeks

Secondary Outcomes (5)

  • 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

Interventions

aliskirenDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Location

Unknown Facility

Investigative Centers, Germany

Location

Related Publications (2)

  • Jackson CE, MacDonald MR, Petrie MC, Solomon SD, Pitt B, Latini R, Maggioni AP, Smith BA, Prescott MF, Lewsey J, McMurray JJ; ALiskiren Observation of heart Failure Treatment (ALOFT) investigators. Associations of albuminuria in patients with chronic heart failure: findings in the ALiskiren Observation of heart Failure Treatment study. Eur J Heart Fail. 2011 Jul;13(7):746-54. doi: 10.1093/eurjhf/hfr031. Epub 2011 Apr 1.

    PMID: 21459891DERIVED

  • McMurray JJ, Pitt B, Latini R, Maggioni AP, Solomon SD, Keefe DL, Ford J, Verma A, Lewsey J; Aliskiren Observation of Heart Failure Treatment (ALOFT) Investigators. Effects of the oral direct renin inhibitor aliskiren in patients with symptomatic heart failure. Circ Heart Fail. 2008 May;1(1):17-24. doi: 10.1161/CIRCHEARTFAILURE.107.740704.

    PMID: 19808266DERIVED

MeSH Terms

Conditions

Heart FailureHypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

May 1, 2005

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

May 17, 2017

Record last verified: 2017-05

Locations

US(1)DE(1)