Longitudinal Registry for Advanced Heart Failure Patients

NCT00364416 | Completed

• 1 other identifier: CR005212
• Study Type: observational
• Target: 1,466
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to gather information to better understand the characteristics, medical management techniques and outcomes of patients with chronic severe Heart Failure (HF).

Conditions

Heart Failure, Congestive; Heart Decompensation

Keywords

Heart Failure, congestive; Heart decompensation

Outcome Measures

Primary Outcomes (1)

• The primary outcome are length of hospitalization and/or time to death

  Patients data are collected for 2 years. Data are collected for all scheduled and unscheduled office visits, and each hospitalization. Individual patient questionnaires are completed at baseline and every 3 months thereafter.

Secondary Outcomes (2)

• Evaluation of medication and other treatment received

  every 3 months

• Evaluation of laboratory results

  evey 3 months

Study Arms (1)

001

Other: Any treatment used to treat CHF

Interventions

Any treatment used to treat CHF OTHER

Clinical Outcomes of Chronic Decompensated Heart Failure patients

001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HF who present with severe symptoms limiting their physical activities at rest

You may qualify if:

• Age older than or equal to 18 years at the time of entry into the Registry
• Patient has been hospitalized 2 times in the past 12 months with a primary diagnosis of HF
• Patient's HF is refractory or relatively refractory to usual non-IV medications, as defined by having received one of the two following regimens for the treatment of HF in that last 60 days: 2 complete IV infusions, each lasting at least 2 hours, of either vasoactive (drugs having an effect on veins or arteries) or inotrope medications (drugs that makes the heart works better), or 3 IV diuretic (drugs that increase the elimination of urine) treatments

You may not qualify if:

• History of any organ transplantation
• Patient is expected to die within the next 5 days
• Patient is seen for consultation or evaluation only, and is unlikely to receive follow-up care at the participating clinic/hospital
• Participation in a clinical study of the drug Natrecor

Sponsors & Collaborators

• Scios, Inc.: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Scios, Inc. Clinical Trial

  Scios, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: October 1, 2002
• Study Completion: April 1, 2006
• Last Updated: April 28, 2010

Record last verified: 2010-04