Safety and Efficacy Study of Add On Aliskiren in Patients With Heart Failure and Renal Impairment (ARIANA-CHF-RD)
This study has been terminated.
(Futility)
Sponsor:
University Medical Centre Groningen
Information provided by (Responsible Party):
H.L. Hillege, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00881439
First received: April 14, 2009
Last updated: May 16, 2013
Last verified: May 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure Kidney Failure |
Drug: Aliskiren Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Heart Failure
Drug Information available for:
Aliskiren
U.S. FDA Resources
Further study details as provided by University Medical Centre Groningen:
Primary Outcome Measures:
- Change in renal blood flow as assessed by 131I-Hippuran clearance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- change in glomerular filtration rate (GFR) as assessed by 125I-Iothalamate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in systolic and diastolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- change in N-terminal pro brain natriuretic peptide levels (NT-proBNP) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in left ventricular ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- change in NYHA class, change in filtration fraction, change in albumin excretion, change in tubular function parameters, change in neurohormonal activation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 41 |
| Study Start Date: | April 2009 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
Matching Placebo once daily, 6 months
|
| Active Comparator: Aliskiren |
Drug: Aliskiren
Oral, 300 mg, once daily, 6 months
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations More Information
Publications:
McMurray JJV, Pitt B, Latini R, Maggioni AP, Solomon SD, Keefe DL, Ford J, Verma A, Lewsey J. Effects of the Oral Direct Renin Inhibitor Aliskiren in Patients With Symptomatic Heart Failure. Circulation Heart Failure 2008;1:17-24
| Responsible Party: | H.L. Hillege, Prof.dr., University Medical Centre Groningen |
| ClinicalTrials.gov Identifier: | NCT00881439 History of Changes |
| Other Study ID Numbers: | ARIANA |
| Study First Received: | April 14, 2009 |
| Last Updated: | May 16, 2013 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) Netherlands: Medicines Evaluation Board (MEB) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by University Medical Centre Groningen:
|
Heart failure Renal Failure Cardiorenal Syndrome Renin inhibition Aliskiren |
Additional relevant MeSH terms:
|
Heart Failure Renal Insufficiency Heart Diseases |
Cardiovascular Diseases Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013