Longitudinal Registry for Advanced Heart Failure Patients

This study has been completed.
Sponsor:
Information provided by:
Scios, Inc.
ClinicalTrials.gov Identifier:
NCT00364416
First received: August 11, 2006
Last updated: April 26, 2010
Last verified: April 2010
  Purpose

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).


Condition Intervention
Heart Failure, Congestive
Heart Decompensation
Other: Any treatment used to treat CHF

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ADHERE (Acute Decompensated Heart Failure National Registry) Longitudinal Module-Registry of Advanced Heart Failure Patients at High Risk for Rehospitalization

Resource links provided by NLM:


Further study details as provided by Scios, Inc.:

Primary Outcome Measures:
  • The primary outcome are length of hospitalization and/or time to death [ Time Frame: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of medication and other treatment received [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
  • Evaluation of laboratory results [ Time Frame: evey 3 months ] [ Designated as safety issue: No ]

Enrollment: 1466
Study Start Date: October 2002
Study Completion Date: April 2006
Groups/Cohorts Assigned Interventions
001 Other: Any treatment used to treat CHF
Clinical Outcomes of Chronic Decompensated Heart Failure patients

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364416

Sponsors and Collaborators
Scios, Inc.
Investigators
Study Director: Scios, Inc. Clinical Trial Scios, Inc.
  More Information

No publications provided

Responsible Party: Sr. Director, Clinical Team Leader, Scios
ClinicalTrials.gov Identifier: NCT00364416     History of Changes
Other Study ID Numbers: CR005212
Study First Received: August 11, 2006
Last Updated: April 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Scios, Inc.:
Heart Failure, congestive
Heart decompensation

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014