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Biomarkers for Prognosis of Ambulatory Chronic Heart Failure Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01113866
First Posted: April 30, 2010
Last Update Posted: May 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Parma
  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

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 29, 2010
First Posted: April 30, 2010
Last Update Posted: May 4, 2010
Last Verified: January 2009

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases