Clinical trial NCT00090259: Study to Evaluate Potential Decrease in Hospitalization Events, Time Between Events, and Increasing Longevity in Patients With Symptomatic Heart Failure (0954-948)
Official title: A Multi-center, Double-Blind, Randomized, Parallel Group Study to Evaluate the Effects of Two Different Doses of Losartan on Morbidity and Mortality in Patients With Symptomatic Heart Failure Intolerant of ACE Inhibitor Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-08-27
Enrollment: 3834
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure
timeFrame: Entire follow-up (median = 4.7 years)
Secondary outcomes:
measure: Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization
timeFrame: Entire follow-up (median = 4.7 years)
measure: Number of Participants That Died (Any Cause)
timeFrame: Entire follow-up (median = 4.7 years)
measure: Number of Participants That Were Hospitalized for Heart Failure
timeFrame: Entire follow-up (median = 4.7 years)
measure: Number of Participants That Experienced Cardiovascular Hospitalization
timeFrame: Entire follow-up (median = 4.7 years)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.