Clinical trial NCT00364416: Longitudinal Registry for Advanced Heart Failure Patients
Official title: ADHERE (Acute Decompensated Heart Failure National Registry) Longitudinal Module-Registry of Advanced Heart Failure Patients at High Risk for Rehospitalization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Congestive
Heart Decompensation
Keywords: Heart Failure, congestive
Heart decompensation
Lead sponsor: Scios, Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 1466
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HF who present with severe symptoms limiting their physical activities at rest

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).

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 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

Primary outcomes:
measure: The primary outcome are length of hospitalization and/or time to death
timeFrame: 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:
measure: Evaluation of medication and other treatment received
timeFrame: every 3 months
measure: Evaluation of laboratory results
timeFrame: evey 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Scios, Inc.
name: Scios, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: