Clincosm LogoSign in Get a demo

Congestive Heart Failure: Causes of Sudden Worsening

Sponsor
University Hospital Hradec Kralove (Other)
Overall Status
Unknown status
CT.gov ID
NCT01081925
Collaborator
(none)
100
Enrollment
1
Location
24
Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to recognize main causes of acute decompensation of chronic congestive heart failure.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Congestive heart failure (CHF) presents a very significant cause of morbidity and mortality. The prevalence of CHF is between 2 and 4% and rises with age (in 70- to 80-year-old people is between 10 and 20%). CHF is the cause of 5% of all acute hospital admissions and accounts for 2% of expenses on health. The most common causes of worsening of the chronic CHF are ischemia, arrhythmias, valvular dysfunction, systemic or pulmonary hypertension, volume overload or fluid retention, high output conditions (infection, anemia, thyrotoxicosis), drugs (NSAIDs, cyclo-oxygenase (COX) inhibitors, thiazolidinediones) and medication nonadherence. The goal of this study is to determine the proportion of various reasons of acute worsening of CHF, using commonly available methods including assessment of serum drug levels.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Congestive Heart Failure: Causes of Sudden Worsening
    Study Start Date :
    Feb 1, 2010
    Anticipated Primary Completion Date :
    Feb 1, 2012
    Anticipated Study Completion Date :
    Feb 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Congestive heart failure

    Patients suffering from sudden worsening of congestive heart failure

    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:

      • able to provide informed consent

      • aged 19 years or more

      • history of heart failure of at least one month

      • examined or hospitalized for acute dyspnea at rest or with minimal exertion

      • clinical signs of fluid overload defined as at least one of following:

      • rales

      • jugular venous distension

      • peripheral edema

      • pulmonary congestion on X-ray

      • NT-proBNP above 210 pmo/l

      Exclusion Criteria:
      • none

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University Hospital Hradec Kralove Hradec Kralove Czech Republic 50005

      Sponsors and Collaborators

      • University Hospital Hradec Kralove

      Investigators

      • Principal Investigator: Radek Pelouch, MD, University Hospital Hradec Kralove

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01081925
      Other Study ID Numbers:
      • MSM0021620817-HKJC
      First Posted:
      Mar 5, 2010
      Last Update Posted:
      Mar 5, 2010
      Last Verified:
      Feb 1, 2010
      Keywords provided by , ,
      Congestive Heart Failure
      Cardiac Failure
      Additional relevant MeSH terms:
      Heart Failure

      Study Results

      No Results Posted as of Mar 5, 2010