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Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Decompensated Systolic Heart Failure

NCT ID: NCT00923156

Last Updated: 2012-07-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-02-28

Brief Summary

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In addition to the blood pressure lowering effects of aliskiren, it may have beneficial effects on blocking the so called RAAS (renin-angiotensin-aldosterone system) at the tissue level. An increase of angiotensin II is associated with progression of heart failure. Although the use of ACE-inhibitors in heart failure shows clinical benefit, an increase in angiotensin II due to an angiotensin II "escape" phenomenon is not desirable. It is not yet known if a direct renin inhibitor can reduce or even prevent the angiotensin II escape phenomenon associated with the use of an ACE-inhibitor. Therefore the study tested the effects of ramipril, aliskiren and the combination of both on levels of angiotensin II in the blood in patients with systolic heart failure

Detailed Description

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Conditions

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Heart Failure

Keywords

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Systolic Aliskiren Ramipril Angiotensin II Ang II Plasma Renin Activity PRA Plasma Renin Concentration PR, brain natriuretic peptide BNP urinary aldosterone Escape Heart failure Pharmacokinetic PK

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aliskiren

In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.

Group Type EXPERIMENTAL

aliskiren

Intervention Type DRUG

Aliskiren 150 mg once daily up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site

ramipril

Intervention Type DRUG

2.5 mg , 5.0 mg or 10 mg once daily

Placebo to ramipril

Intervention Type DRUG

Matching placebo to ramipril capsule in double blind phase

Ramipril

In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.

In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet.

Group Type EXPERIMENTAL

ramipril

Intervention Type DRUG

2.5 mg , 5.0 mg or 10 mg once daily

Placebo to aliskiren

Intervention Type DRUG

matching placebo to aliskiren in double blind phase

Aliskiren plus Ramipril

In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.

In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site

Group Type EXPERIMENTAL

aliskiren

Intervention Type DRUG

Aliskiren 150 mg once daily up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site

ramipril

Intervention Type DRUG

2.5 mg , 5.0 mg or 10 mg once daily

Interventions

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aliskiren

Aliskiren 150 mg once daily up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site

Intervention Type DRUG

ramipril

2.5 mg , 5.0 mg or 10 mg once daily

Intervention Type DRUG

Placebo to aliskiren

matching placebo to aliskiren in double blind phase

Intervention Type DRUG

Placebo to ramipril

Matching placebo to ramipril capsule in double blind phase

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Decompensated systolic heart failure, left ventricular ejection fraction ≤40%
* Brain natriuretic peptide (BNP) level ≥ 100 pg/mL

Exclusion Criteria

* Use of Angiotensin Converting Enzyme(ACE) or Angiotensin Receptor Blocker (ARB) inhibitor treatment following the run-in period or requirement of both treatments
* Acute heart failure secondary to acute myocardial infarction, acute coronary syndrome or new tachyarrhythmia
* Occurrence of unstable angina or myocardial infarction within 12 weeks prior to screening
* History of cardiomyopathy such as postpartum, restrictive, infective, hypertrophic obstructive
* History of right heart failure due to pulmonary disease
* History of untreated second or third degree atrioventricular heart block
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigator Site

Bad Krozingen, , Germany

Site Status

Novartis Investigator Site

Berlin, , Germany

Site Status

Novartis Investigator Site

Berlin, , Germany

Site Status

Novartis Investigator Site

Göttingen, , Germany

Site Status

Novartis Investigator Site

Jena, , Germany

Site Status

Novartis Investigator Site

München, , Germany

Site Status

Novartis Investigator Site

Krakow, , Poland

Site Status

Novartis Investigator Site

Lublin, , Poland

Site Status

Novartis Investigator Site

Poznan, , Poland

Site Status

Novartis Investigator Site

Warsaw, , Poland

Site Status

Novartis Investigator Site

Wroclaw, , Poland

Site Status

Novartis Investigator Site

Moscow, , Russia

Site Status

Novartis Investigator Site

Moscow, , Russia

Site Status

Novartis Investigator Site

Moscow, , Russia

Site Status

Novartis Investigator Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Countries

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Germany Poland Russia

References

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Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.

Reference Type DERIVED
PMID: 33089502 (View on PubMed)

Other Identifiers

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EudraCT 2008-001035-35

Identifier Type: -

Identifier Source: secondary_id

CSPP100A2252

Identifier Type: -

Identifier Source: org_study_id