Registry for Acute Decompensated Heart Failure Patients

October 29, 2009 updated by: Scios, Inc.

ADHERE Core III - Acute Decompensated Heart Failure Registry

The purpose of the ADHERE study is to develop a multi-center, observational, open-label registry of the management strategies of patients treated in the hospital for acute Heart Failure in the United States.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective is to compile a clinical database on the strategy for the medical management of patients hospitalized with acute Heart Failure (HF). Through the use of the information collected from acute care hospitals across the United States the following information may be coming out of this study: 1) Assist hospitals in evaluating and improving quality of care for patients with acute HF by tracking quality indicators and providing benchmark data reports; 2) Describe the demographic and clinical characteristics of patients who are hospitalized with acute HF; 3) Characterize the initial emergency department evaluation and subsequent inpatient management of patients hospitalized with acute HF; 4) Identify patient characteristics and medical care practices associated with improved health outcomes in those hospitalized with acute HF; 5) Characterize trends and changes over time in the management of acute HF; 6) Offer surveillance of adherence to practice guidelines as these emerge for the inpatient management of acute HF. Observational Study - No investigational drug administered

Study Type

Observational

Enrollment (Actual)

24118

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

All consecutive adult patients admitted to an acute care hospital and treated actively for acute HF, where acute HF is defined clinically as a new onset with HF decompensation

Description

Inclusion Criteria:

  • Age greater than or equal to 18 years at the time of admission to the hospital
  • Received or is eligible to receive a principal hospital discharge diagnosis of HF
  • Decompensated HF is present as determined clinically by the patient care team

Exclusion Criteria:

  • HF is present as a co-morbid condition, but is not a principal focus of diagnosis or treatment during this hospitalization episode

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
Other: Acute Decompensated Heart Failure
Treatment & outcomes during hospital admission for Acute DHF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Course of care in the Emergency Department (ED) and course of care in the inpatient hospital, use of diuretics (increase urine excretion) vasodilators (relax artey and veins) and inotropeic agents (increase the function of the heart) rate of death
Time Frame: From admission to discharge from the hospital
From admission to discharge from the hospital

Secondary Outcome Measures

Outcome Measure
Time Frame
Data from patient demographics ( sex, age, gender, race)
Time Frame: at patients admission
at patients admission

Collaborators and Investigators

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

Sponsor

Scios, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2001

Primary Completion

December 7, 2022

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

August 18, 2006

First Submitted That Met QC Criteria

August 18, 2006

First Posted (Estimate)

August 21, 2006

Study Record Updates

Last Update Posted (Estimate)

November 1, 2009

Last Update Submitted That Met QC Criteria

October 29, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005194

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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