NCT01113866

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 1998

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1998

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2010

Completed
Last Updated

May 4, 2010

Status Verified

January 1, 2009

Enrollment Period

4.6 years

First QC Date

April 29, 2010

Last Update Submit

May 3, 2010

Conditions

Heart Failure

Study Arms (1)

heart failure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

heart failure patients with preserved or impaired systolic function

You may qualify if:

  • symptomatic congestive heart failure lasting at least six months
  • reduced exercise tolerance
  • impaired or preserved left ventricular ejection fraction
  • cardiomegaly

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università di Parma

Parma, 43126, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Aderville Cabassi, MD

    University of Parma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 29, 2010

First Posted

April 30, 2010

Study Start

October 1, 1998

Primary Completion

May 1, 2003

Study Completion

January 1, 2009

Last Updated

May 4, 2010

Record last verified: 2009-01

Locations

IT(1)