Heart Failure, CongestiveNCT00364416
Longitudinal Registry for Advanced Heart Failure Patients
An observational study of Heart Failure, Congestive and Heart Decompensation, run by Scios, Inc..
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive, Heart Decompensation
- What is being tested?
- Any treatment used to treat CHF
- How many people
- 1,466 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Apr 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HF who present with severe symptoms limiting their physical activities at rest
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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).
Read the 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
- Conditions
- Heart Failure, Congestive, Heart Decompensation
- Being tested
- Any treatment used to treat CHF
- Keywords
- Heart Failure, congestive, Heart decompensation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any treatment used to treat CHFOther
Clinical Outcomes of Chronic Decompensated Heart Failure patients
| Study group | Role | What they receive |
|---|---|---|
| 001 | Not described Receives: Other: Any treatment used to treat CHF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome are length of hospitalization and/or time to death
Measured: 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 (2)
Evaluation of medication and other treatment received
Measured: every 3 months
Evaluation of laboratory results
Measured: evey 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startOct 2002
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scios, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scios, Inc. Clinical Trial, Study director, Scios, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364416
- Sponsor's protocol ID
- CR005212
- Status last verified
- Apr 2010
- First submitted
- 11 Aug 2006
- Last updated
- 28 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADHERE (Acute Decompensated Heart Failure National Registry) Longitudinal Module-Registry of Advanced Heart Failure Patients at High Risk for Rehospitalization
- ClinicalTrials.gov ID
- NCT00364416
- Acronym / sponsor ID
- CR005212
- Conditions
- Heart Failure, Congestive, Heart Decompensation
- Keywords
- Heart Failure, congestive, Heart decompensation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,466 participants (actual)
- Lead sponsor
- Scios, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2002
- Study completion
- Apr 2006 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Other: Any treatment used to treat CHF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HF who present with severe symptoms limiting their physical activities at rest
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Any treatment used to treat CHFClinical Outcomes of Chronic Decompensated Heart Failure patients | Other | 001 |
Primary outcome
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.
2 secondary outcomes
Evaluation of medication and other treatment received
Time frame: every 3 months
Evaluation of laboratory results
Time frame: evey 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scios, Inc. Clinical Trial study director
Scios, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Congestive and Heart Decompensation, run by Scios, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2010.