Heart DecompensationNCT03566264
Study of the Sudden Heart Failure Participant Population in the US
An observational study of Heart Decompensation, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
An observational study using data from a large US electronic health record database to find participants hospitalized with ADHF who do not have a concurring heart attack Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Decompensation
- What is being tested?
- Non-Interventional
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Aug 2017to 15 Dec 2020
- 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: Study population will be participants hospitalized with ADHF who do not have a coincident myocardial infarction and who have at least 6 months of activity in the database prior to the hospitalization
Who may be able to join
- Age 18 years or older on the index date
- At least 6 months of activity in the database
- An inpatient visit with at least one of the following ICD-9 or ICD-10 diagnosis codes (ICD-9 diagnosis codes: 428.xx, 785.51 or ICD-10 diagnosis codes: I50.xx, R57.0) in the primary or secondary position OR mention of "heart failure" on the admission record
Who cannot join
- An average LVEF ≥ 40 during the hospitalization
- Any code for myocardial infarction (ICD-9 diagnosis code: 410.xx, ICD-10 diagnosis code: I21.xx) or related terms such as "myocardial infarction", "mi", "infarct" or "heart attack" occurring during the index hospitalization
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bristol-Myers Squibb
Princeton, New Jersey, 08540
Local Institution
Princeton, New Jersey, 08540
About this study
Official title: Characterizing the Acute Decompensated Heart Failure (ADHF) Patient Population in the United States (US)
An observational study using data from a large US electronic health record database to find participants hospitalized with ADHF who do not have a concurring heart attack
- Conditions
- Heart Decompensation
- Being tested
- Non-Interventional
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Participants hospitalized with ADHF | Not described Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of comorbid events among hospitalized ADHF participants
Measured: In the 30 days after discharge
Incidence of participants hospitalized with ADHF
Measured: Up to 66 months
Incidence of participants hospitalized with ADHF
Measured: In the 30 days after discharge
Incidence of comorbid events among hospitalized ADHF participants
Measured: Up to 66 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start22 Aug 2017
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Why it stopped: Program has been terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DecompensationStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566264
- Sponsor's protocol ID
- CV013-031
- Status last verified
- Jul 2022
- First submitted
- 24 Apr 2018
- Last updated
- 8 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Acute Decompensated Heart Failure (ADHF) Patient Population in the United States (US)
- ClinicalTrials.gov ID
- NCT03566264
- Acronym / sponsor ID
- CV013-031
- Conditions
- Heart Decompensation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Program has been terminated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 25 Jun 2018 (actual)
- 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.
An observational study using data from a large US electronic health record database to find participants hospitalized with ADHF who do not have a concurring heart attack
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants hospitalized with ADHF | – | Other: Non-Interventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be participants hospitalized with ADHF who do not have a coincident myocardial infarction and who have at least 6 months of activity in the database prior to the hospitalization
Key inclusion criteria (3 listed)
- Age 18 years or older on the index date
- At least 6 months of activity in the database
- An inpatient visit with at least one of the following ICD-9 or ICD-10 diagnosis codes (ICD-9 diagnosis codes: 428.xx, 785.51 or ICD-10 diagnosis codes: I50.xx, R57.0) in the primary or secondary position OR mention of "heart failure" on the admission record
Key exclusion criteria (3 listed)
- An average LVEF ≥ 40 during the hospitalization
- Any code for myocardial infarction (ICD-9 diagnosis code: 410.xx, ICD-10 diagnosis code: I21.xx) or related terms such as "myocardial infarction", "mi", "infarct" or "heart attack" occurring during the index hospitalization
- Other protocol defined inclusion/exclusion criteria could apply
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 |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | Participants hospitalized with ADHF |
Primary outcome
Incidence of comorbid events among hospitalized ADHF participants
Time frame: In the 30 days after discharge
Incidence of participants hospitalized with ADHF
Time frame: Up to 66 months
Incidence of participants hospitalized with ADHF
Time frame: In the 30 days after discharge
Incidence of comorbid events among hospitalized ADHF participants
Time frame: Up to 66 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Heart Decompensation
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
Not yet recruiting
Exercise, Mediterranean Diet and Inflammation in Heart Failure
Heart Failure, Heart Failure Preserved Ejection Fraction
RecruitingObservational study
Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance
Venous Thromboembolism (VTE), Chronic Thromboembolic Pulmonary Hypertension
RecruitingObservational study
Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction
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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Decompensation, run by Bristol-Myers Squibb at 2 sites in United States.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of comorbid events among hospitalized ADHF participants (time frame: In the 30 days after discharge). The study lists 4 primary outcomes in all. 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 8 Jul 2022.