Impact of Clinical, Demographic and Laboratory Variables on Brain Natriuretic Peptide Levels

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01382394
Collaborator
(none)
60
1
11
5.5

Study Details

Study Description

Brief Summary

Brain natriuretic peptide (BNP) is involved in the regulation of blood pressure and fluid volume. It is used for the early diagnosis of heart failure (HF) in patients presenting to the emergency room with dyspnea. Interleukin-6 (IL-6) is a cytokine marker of inflammation that exhibits significant prognostic value in predicting severity and outcome of sepsis. Recently, it was suggested that inflammatory cytokines play an important role in the development of heart failure. Procalcitonin (PCT) is a propeptide of calcitonin which is normally produced in the C-cells of the thyroid glands. Although physiologic levels of PCT remain very low, a dramatic increase in serum PCT levels is observed during severe systemic infections. These properties make procalcitonin less useful for the diagnosis of simple infections but a very promising marker of severe infections especially in the critical care setting.

To investigate the co-relation between BNP, IL-6 and procalcitonin in two groups of patients; those presenting with the diagnosis of decompensated heart failure and in patients presenting with the diagnosis of sepsis without cardiovascular or hemodynamic dysfunction.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Brain natriuretic peptide (BNP), forms together with atrial natriuretic peptide (ANP) a peptide family involved in the regulation of blood pressure and fluid volume. It is used for the early diagnosis of heart failure (HF) in patients presenting to the emergency room with dyspnea. Additionally, in patients with chronic HF and acute and chronic coronary syndrome, BNP is a marker of unfavorable prognosis, being associated with increased mortality.

    Recently, elevated BNP levels have been measured in patients with septic shock and have been attributed to myocardial dysfunction due to sepsis. Because BNP synthesis is also induced by endotoxin and inflammatory mediators, the mechanisms leading to elevated BNP levels in patients with sepsis remain unclear.

    Interleukin-6 (IL-6) is a cytokine marker of inflammation that exhibits significant prognostic value in predicting severity and outcome of sepsis, since it is considered to play a key role in the pathogenesis of sepsis. Accumulating evidence suggests that inflammatory cytokines play an important role in the development of heart failure. In particular, studies using genetically engineered animal models have demonstrated the critical role of the gp130-dependent cardiomyocyte survival pathway in the transition to heart failure. However, the significance of gp130 for patients with CHF has not been fully assessed. Previous clinical studies showed that the plasma level of IL-6 is elevated in patients with advanced CHF and that such high levels are associated with a poor prognosis for CHF patients.

    Procalcitonin (PCT) is a propeptide of calcitonin which is normally produced in the C-cells of the thyroid glands. Although physiologic levels of PCT remain very low, a dramatic increase in serum PCT levels is observed during severe systemic infections. It is not infection per se but infection accompanied by severe systemic reactions or poor organ perfusion that increases procalcitonin levels. These properties make procalcitonin less useful for the diagnosis of simple infections but a very promising marker of severe infections especially in the critical care setting.

    Few studies have investigated the role of procalcitonin in patients with acute heart failure, although there was a slightly increased level of procalcitonin in patients with severe acute heart failure, the results were not conclusive. These results support the hypothesis that inflammatory process has a role in heart failure.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Clinical, Demographic and Laboratory Variables on Brain Natriuretic Peptide Levels
    Study Start Date :
    Jul 1, 2009
    Actual Primary Completion Date :
    Jun 1, 2010
    Actual Study Completion Date :
    Jun 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Sepsis Group, Heart failure group

    The first group will include 60 patients with the diagnosis of acute decompensated heart failure. The second group will include 60 patients with the diagnosis of sepsis.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
        1. Patients with decompensated heart failure (N-60).
        1. Patients with sepsis (N-60).
      Exclusion Criteria:
        1. Patients who are under the age of 18 years
        1. pregnant women.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Internal Medicine "B", Rambam Medical center Haifa Israel 31096

      Sponsors and Collaborators

      • Rambam Health Care Campus

      Investigators

      • Study Chair: Zaher S Azzam, MD, Head Of Internal Medicine "B"

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01382394
      Other Study ID Numbers:
      • 0459-09-RMB
      First Posted:
      Jun 27, 2011
      Last Update Posted:
      Aug 4, 2011
      Last Verified:
      Aug 1, 2011
      Keywords provided by , ,
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Aug 4, 2011