Longitudinal Registry for Advanced Heart Failure Patients

Heart Failure, Congestive Clinical Trial

Official title:

ADHERE (Acute Decompensated Heart Failure National Registry) Longitudinal Module-Registry of Advanced Heart Failure Patients at High Risk for Rehospitalization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364416
• Other study ID #: CR005212
• Status: Completed
• Phase: N/A
• First received: August 11, 2006
• Last updated: April 26, 2010
• Start date: October 2002
• Est. completion date: April 2006

Study information

• Verified date: April 2010
• Source: Scios, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Description:

This objectives of this observational registry are: to assess changes in patient quality of life as a function of medical management and disease progression as measured by the rate of death and rehospitalization, and assist with the optimization of heart failure (HF) management by providing information on the use of therapies proven to be effective and to describe practices of standard of care for chronic treatment of symptoms of HF outside the hospital and during hospitalization for acute episode with intravenous vasoactive medication (drugs which affect the blood vessels and muscle of the heart). Additional information which will be gathered include patient characteristics (age, sex, race, medical history, symptoms), infusion setting, type of medication, dose and frequency of medication and worsening of congestive heart failure disease. Participants in the study receive an unique patient-specific identifier and all available data will be analyzed. Observational Study - No investigational drug administered

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1466
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age older than or equal to 18 years at the time of entry into the Registry

• Severe symptoms of HF at rest with marked limitation of physical activity continuously for at least 60 days prior to inclusion in 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Decompensation
• Heart Failure
• Heart Failure, Congestive

Intervention

Other:
• Any treatment used to treat CHF
Clinical Outcomes of Chronic Decompensated Heart Failure patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scios, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Evaluation of medication and other treatment received		every 3 months	No
Secondary	Evaluation of laboratory results		evey 3 months	No