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NT-proBNP and New Biomarkers in Patients With Dyspnea and/or Peripheral Edema (MANPRO)

U

Universitätsmedizin Mannheim

Status

Completed

Conditions

Dyspnea
Peripheral Edema

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

The objectives of this study are to:

  • Evaluate the sensitivity and specificity of NT-proBNP (N-terminal prohormone brain natriuretic peptide) and new biomarker measurements for the diagnosis of heart failure in patients with acute dyspnea and/or edema.
  • Determine the exact biomarker cut-off point(s) for the differentiation of healthy persons, patients with heart failure and patients with dyspnea of other origin.
  • Evaluate treatment costs in patients with dyspnea under special consideration of NT-proBNP measurement.

Full description

Primary endpoint:

  • Sensitivity and specificity of biomarker measurements for discrimination of heart failure from dyspnea of other origin.

Secondary endpoints:

  • Determination of Cut-off(s)
  • Discrimination of cardiac and non-cardiac diseases causing to dyspnea or peripheral edema
  • Determination of treatment costs of the initial hospital stay
  • Evaluation of resource savings when implementing NT-proBNP for determination of diagnosis.
  • Time to diagnosis.
  • Hospitalization rate /Intensive care treatment rate between day 1 and 28
  • Duration of initial hospital stay
  • 30-day re-hospitalization rate
  • 30 day mortality rate and adverse event rate
  • 1 and 5 year mortality rates
  • 1 and 5 year rehospitalization rates

Enrollment

400 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 18-90 years
  • Dyspnea or/and peripheral edema
  • Informed consent

Exclusion criteria

  • Renal insufficiency with creatinine > 2.8mg/dl
  • Anemia (hemoglobin < 8.0mg/dl)
  • Pregnancy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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