Study to Evaluate Potential Decrease in Hospitalization Events, Time Between Events, and Increasing Longevity in Patients With Symptomatic Heart Failure (0954-948)

NCT ID: NCT00090259

Last Updated: 2024-05-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3834 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-19

Study Completion Date

2009-05-13

Brief Summary

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This is a multicenter study to evaluate potential decrease in hospitalization events and time between events and increasing longevity in patients with symptomatic congestive heart failure and intolerant of first-line medication for heart failure. This study will evaluate if higher doses of the investigational drug given daily will be superior to the lower dose of the same investigational drug given daily.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Losartan 50 mg

50-mg losartan tablet administered daily with 1 tablet of 100-mg losartan placebo beginning Week 1 and continuing to end of study (up to 4 years)

Group Type EXPERIMENTAL

Losartan 50 mg

Intervention Type DRUG

50-mg losartan oral tablet

Losartan 150 mg

Titrated losartan administration up to daily 150-mg losartan: Week 1, daily 50-mg losartan tablet coadministered with 100-mg losartan placebo; Week 2, daily 50-mg losartan placebo coadministered with 100-mg losartan; Week 3 to end of study (up to 4 years), daily 50-mg losartan tablet coadministered with 100-mg losartan

Group Type EXPERIMENTAL

Losartan 150 mg

Intervention Type DRUG

100-mg losartan oral tablet + 50-mg losartan oral tablet

Interventions

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Losartan 50 mg

50-mg losartan oral tablet

Intervention Type DRUG

Losartan 150 mg

100-mg losartan oral tablet + 50-mg losartan oral tablet

Intervention Type DRUG

Other Intervention Names

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Losartan potassium Losartan potassium

Eligibility Criteria

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Inclusion Criteria

* Symptomatic heart failure with known or recently diagnosed intolerance of treatment with first-line medication for heart failure
* May or may not be receiving an alternative and/or additional drug treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Upshaw JN, Konstam MA, Klaveren Dv, Noubary F, Huggins GS, Kent DM. Multistate Model to Predict Heart Failure Hospitalizations and All-Cause Mortality in Outpatients With Heart Failure With Reduced Ejection Fraction: Model Derivation and External Validation. Circ Heart Fail. 2016 Aug;9(8):e003146. doi: 10.1161/CIRCHEARTFAILURE.116.003146.

Reference Type DERIVED
PMID: 27514751 (View on PubMed)

Rossignol P, Girerd N, Gregory D, Massaro J, Konstam MA, Zannad F. Increased visit-to-visit blood pressure variability is associated with worse cardiovascular outcomes in low ejection fraction heart failure patients: Insights from the HEAAL study. Int J Cardiol. 2015;187:183-9. doi: 10.1016/j.ijcard.2015.03.169. Epub 2015 Mar 17.

Reference Type DERIVED
PMID: 25828348 (View on PubMed)

Kiernan MS, Gregory D, Sarnak MJ, Rossignol P, Massaro J, Kociol R, Zannad F, Konstam MA. Early and late effects of high- versus low-dose angiotensin receptor blockade on renal function and outcomes in patients with chronic heart failure. JACC Heart Fail. 2015 Mar;3(3):214-23. doi: 10.1016/j.jchf.2014.11.004.

Reference Type DERIVED
PMID: 25742759 (View on PubMed)

Konstam MA, Neaton JD, Dickstein K, Drexler H, Komajda M, Martinez FA, Riegger GA, Malbecq W, Smith RD, Guptha S, Poole-Wilson PA; HEAAL Investigators. Effects of high-dose versus low-dose losartan on clinical outcomes in patients with heart failure (HEAAL study): a randomised, double-blind trial. Lancet. 2009 Nov 28;374(9704):1840-8. doi: 10.1016/S0140-6736(09)61913-9. Epub 2009 Nov 16.

Reference Type DERIVED
PMID: 19922995 (View on PubMed)

Other Identifiers

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2004_004

Identifier Type: -

Identifier Source: secondary_id

0954-948

Identifier Type: -

Identifier Source: org_study_id

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