Longitudinal Registry for Advanced Heart Failure Patients

April 26, 2010 updated by: Scios, Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

1466

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
Other: Any treatment used to treat CHF
Clinical Outcomes of Chronic Decompensated Heart Failure patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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 Outcome Measures

Outcome Measure
Time Frame
Evaluation of medication and other treatment received
Time Frame: every 3 months
every 3 months
Evaluation of laboratory results
Time Frame: evey 3 months
evey 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scios, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion (ACTUAL)

April 1, 2006

Study Registration Dates

First Submitted

August 11, 2006

First Submitted That Met QC Criteria

August 14, 2006

First Posted (ESTIMATE)

August 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 28, 2010

Last Update Submitted That Met QC Criteria

April 26, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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