Biomarkers for Prognosis of Ambulatory Chronic Heart Failure Patients

This study has been completed.
Sponsor:
Information provided by:
University of Parma
ClinicalTrials.gov Identifier:
NCT01113866
First received: April 29, 2010
Last updated: May 3, 2010
Last verified: January 2009
  Purpose

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.


Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating Biomarkers as Prognostic Indicators of Death in Ambulatory Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by University of Parma:

Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 124
Study Start Date: October 1998
Study Completion Date: January 2009
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Groups/Cohorts
heart failure

Detailed 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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

heart failure patients with preserved or impaired systolic function

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113866

Locations
Italy
Università di Parma
Parma, Italy, 43126
Sponsors and Collaborators
University of Parma
Investigators
Principal Investigator: Aderville Cabassi, MD University of Parma
  More Information

No publications provided

Responsible Party: Aderville Cabassi, Hypertension and Cardiorenal Disease Center Dept Internal Medicine Nephrology and Health Sciences University of Parma
ClinicalTrials.gov Identifier: NCT01113866     History of Changes
Other Study ID Numbers: CV-1997-2002_A0013-29943
Study First Received: April 29, 2010
Last Updated: May 3, 2010
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014