Biomarkers for Prognosis of Ambulatory Chronic Heart Failure Patients

Heart Failure Clinical Trial

Official title:

Circulating Biomarkers as Prognostic Indicators of Death in Ambulatory Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113866
• Other study ID #: CV-1997-2002_A0013-29943
• Status: Completed
• Phase: N/A
• First received: April 29, 2010
• Last updated: May 3, 2010
• Start date: October 1998
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: University of Parma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Biomarkers representing distinct biological domains including neurohormonal, inflammatory, metabolic-nutritional, oxidative-nitrosative and myocardial injury, might alone or in combination provide prognostic information on mortality in heart failure patients with preserved or impaired systolic function.

Description:

Upon enrollment in the study, Troponin I (cTn I), BNP, norepinephrine, plasma renin activity, aldosterone, high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), soluble receptor of interleukin 2 (sIL-2R), leptin, prealbumin, free malondialdehyde, 15-F2t-isoprostane and protein-bound nitrotyrosine were measured in stable ambulatory, non diabetic, elderly heart failure patients. Patients were followed up until death or study termination (31st January 2009).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: January 2009
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• symptomatic congestive heart failure lasting at least six months

• reduced exercise tolerance

• impaired or preserved left ventricular ejection fraction

• cardiomegaly

Exclusion Criteria:

• acute infection

• rheumatoid or other autoimmune diseases

• primary cachectic states (cancer, thyroid disease, severe liver disease)

• severe chronic lung disease

• neuromuscular disorders

• myocardial infarction within the previous 20 weeks

• diabetes mellitus

• chronic renal failure (serum creatinine level > 2.0 mg/dl, >177 micromol/L)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Italy	Università di Parma	Parma

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy,