NCT00881439

Brief Summary

The main purpose of this study is to examine the effect of add-on therapy with the direct renin inhibitor Aliskiren in comparison to placebo on renal blood flow in patients with heart failure and reduced renal function.

  • Primary outcome measure: change in renal blood flow at 6 months
  • Secondary outcome measures: changes in renal function, N-terminal pro Brain natriuretic peptide, left ventricular function, blood pressure and neurohormones

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_2 heart-failure

Timeline
Completed

Started Apr 2009

Typical duration for phase_2 heart-failure

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 17, 2013

Status Verified

May 1, 2013

Enrollment Period

3.3 years

First QC Date

April 14, 2009

Last Update Submit

May 16, 2013

Conditions

Heart FailureKidney Failure

Keywords

Heart failureRenal FailureCardiorenal SyndromeRenin inhibitionAliskiren

Outcome Measures

Primary Outcomes (1)

  • Change in renal blood flow as assessed by 131I-Hippuran clearance

    6 months

Secondary Outcomes (5)

  • change in glomerular filtration rate (GFR) as assessed by 125I-Iothalamate

    6 months

  • Change in systolic and diastolic blood pressure

    6 months

  • change in N-terminal pro brain natriuretic peptide levels (NT-proBNP)

    6 months

  • Change in left ventricular ejection fraction

    6 months

  • change in NYHA class, change in filtration fraction, change in albumin excretion, change in tubular function parameters, change in neurohormonal activation

    6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Aliskiren

ACTIVE COMPARATOR
Drug: Aliskiren

Interventions

AliskirenDRUG

Oral, 300 mg, once daily, 6 months

Also known as: Rasilez, SPP100
Aliskiren
PlaceboDRUG

Matching Placebo once daily, 6 months

Placebo

Eligibility Criteria

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

You may qualify if:

  • NYHA II-IV Heart Failure
  • Left ventricular ejection fraction \< 45%
  • Stable heart failure medication
  • eGFR by sMDRD formula between 30 and 60 mL/min/1.73m2

You may not qualify if:

  • Known hypersensitivity to study drug or ACEi
  • Concomitant treatment with both ARB and Aldosterone Receptor Antagonist
  • Symptomatic Hypotension
  • Acute Heart Failure
  • History of stroke, acute coronary syndrome, PCI or angioplasty within past 3 months
  • Serum potassium \> 5.2 mmol/L
  • Right heart failure due to severe pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

Location

Related Publications (2)

  • 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: 19808266BACKGROUND

  • Schroten NF, Damman K, Hemmelder MH, Voors AA, Navis G, Gaillard CA, van Veldhuisen DJ, Van Gilst WH, Hillege HL. Effect of additive renin inhibition with aliskiren on renal blood flow in patients with Chronic Heart Failure and Renal Dysfunction (Additive Renin Inhibition with Aliskiren on renal blood flow and Neurohormonal Activation in patients with Chronic Heart Failure and Renal Dysfunction). Am Heart J. 2015 May;169(5):693-701.e3. doi: 10.1016/j.ahj.2014.12.016. Epub 2015 Jan 7.

    PMID: 25965717DERIVED

MeSH Terms

Conditions

Heart FailureRenal InsufficiencyCardio-Renal Syndrome

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.dr.

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 15, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2012

Study Completion

December 1, 2012

Last Updated

May 17, 2013

Record last verified: 2013-05

Locations

NL(1)