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Heart FailurePhase 2ARIANA-CHF-RDNCT00881439

Safety and Efficacy Study of Add On Aliskiren in Patients With Heart Failure and Renal Impairment

A Phase 2 study testing Aliskiren in people with Heart Failure and Kidney Failure, run by University Medical Center Groningen at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Kidney Failure
What is being tested?
Aliskiren
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
1 siteNetherlands
Study dates
Apr 2009to Dec 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center Groningen

    Groningen

Other trials in Netherlands

About this study

Official title: A Double-blind, Placebo-controlled, Randomized Trial Investigating the Safety and Efficacy of Additive Renin Inhibition With Aliskiren on Renal Blood Flow and Neurohormonal Activation in Patients With Chronic Heart Failure and Renal Dysfunction

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
Read the detailed description

This study is a randomized, double-blind, placebo controlled, parallel group comparison trial, enrolling 100 patients (67 vs. 33) with stable CHF. Patients will be randomized to Aliskiren 300 mg once daily or corresponding Placebo for a period of 6 months. Efficacy measures will be performed at baseline and at the end of the study. Primary efficacy outcome is change in renal blood flow as measured by 131I-Hippuran clearance. Secondary outcome include change in renal function, neurohormones, left ventricular function and blood pressure. Safety assessments include renal function, changes in electrolytes, and blood pressure. Patients will be uptitrated to maximum tolerated doses of Aliskiren, and safety visits are planned 1 week after initiation and on a 2 month interval afterwards. A total of 8 visits are planned during the entire study period.

Being tested
Aliskiren, Placebo
Keywords
Heart failure, Renal Failure, Cardiorenal Syndrome, Renin inhibition, Aliskiren
Medical subject headings
Heart Failure, Renal Insufficiency, Cardio-Renal Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AliskirenDrug

    Also called Rasilez, SPP100

    Oral, 300 mg, once daily, 6 months

  • PlaceboDrug

    Matching Placebo once daily, 6 months

Study groups in NCT00881439
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
AliskirenActive comparatorNot described
Receives: Drug: Aliskiren

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (5)

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

    Measured: 6 months

  2. Change in systolic and diastolic blood pressure

    Measured: 6 months

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

    Measured: 6 months

  4. Change in left ventricular ejection fraction

    Measured: 6 months

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionJul 2012
  4. Study completionDec 2012

Why it stopped: Futility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00881439
Sponsor's protocol ID
ARIANA
Acronym
ARIANA-CHF-RD
Status last verified
May 2013
First submitted
14 Apr 2009
Last updated
17 May 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19808266

  • 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.

    PubMed 25965717

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aliskiren in people with Heart Failure and Kidney Failure, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Futility). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in renal blood flow as assessed by 131I-Hippuran clearance (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00881439, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2013.

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