Acute Heart FailureNCT02350114
An Observational Study of the Functional Capacity of Heart Failure
A study testing 6 Minute Walk Test in people with Acute Heart Failure, run by Bristol-Myers Squibb at 6 sites in United States.
Trial summary
This is an observational study of the functional capacity of patients with Heart failure with Reduced Ejection Fraction (HFrEF) who are admitted to the hospital for routine medical treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- 6 Minute Walk Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2014to Jul 2015
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a left ventricular ejection fraction (LVEF) ≤40%, as assessed by any method, e.g., echocardiography, a multigated acquisition (MUGA) scan or magnetic resonance imaging (MRI);
- Present with signs and symptoms considered to be primarily due to AHF and be admitted to the hospital for AHF;
- Confirmation verbally that the patient was ambulatory, i.e., able to walk >30m, prior to developing symptoms of AHF leading to the current admission;
- Be capable of understanding the nature of the trial; be willing and able to comply with the inpatient and outpatient study protocol requirements for the duration of the study; and be willing to participate, as documented by written informed consent.
Who cannot join
- Have a systolic blood pressure <90mmHg or >170mmHg at baseline;
- Have an anticipated need for an invasive procedure within 3 days of study enrollment, e.g., due to hemodynamic or cardiac rhythm instability, or acute coronary syndrome, requiring procedures including, but not limited to, cardiac catheterization, placement of a defibrillator/pacemaker, or placement of a pulmonary artery catheter;
- Have a primary HF etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic cardiomyopathy (as defined by any wall thickness > 1.8cm) that is obstructive, or uncorrected severe valvular disease (except mitral regurgitation);
- Have any other comorbidities that limit ambulation more than the patient's heart failure, e.g., symptomatic peripheral arterial disease, COPD, arthritis or other condition, as confirmed verbally with the patient;
- Have severe renal insufficiency (defined as a GFR <30mL/min/1.73m2 according to the MDRD equation);
- Have an anticipated survival of less than 90 days, for any reason;
- Have received an investigational agent (drug, device or biologic product) within 30 days (or, if longer, 5 half-lives for a drug or biologic agent) prior to study entry, or be planning to receive an investigational agent at any time throughout the full duration of the study until at least Study Day 35;
- Have any other clinically significant laboratory abnormality, medical condition or social circumstance that, in the investigator's opinion, makes it inappropriate for the patient to participate in this clinical trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cardioxyl Study Site
Cincinnati, Ohio, 45206
Cardioxyl Study Site
Detroit, Michigan, 48202
Cardioxyl Study Site
Detroit, Michigan, 48282
Cardioxyl Study Site
Indianapolis, Indiana, 46202
Cardioxyl Study Site
Nashville, Tennessee, 37232
Cardioxyl Study Site
Winston-Salem, North Carolina, 27157
About this study
Official title: An Observational Study of the Functional Capacity of Heart Failure Patients With Reduced Ejection Fraction Admitted With Acute Heart Failure
This is an observational study of the functional capacity of patients with Heart failure with Reduced Ejection Fraction (HFrEF) who are admitted to the hospital for routine medical treatment.
Read the detailed description
This observational study will evaluate the functional capacity (ability to walk and distance walked) of patients with Heart failure with Reduced Ejection Fraction (HFrEF) in approximately 50-70 patients who present with Acute Heart Failure to approximately 5-6 hospital sites in the USA. All enrolled patients will be evaluated for their baseline functional capacity. Patients will receive standard Acute Heart Failure therapy and will be serially assessed for change in their functional capacity.
- Conditions
- Acute Heart Failure
- Being tested
- 6 Minute Walk Test
- Keywords
- Heart failure, 6 Minute Walk Test
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 Minute Walk TestProcedure or surgery
Also called Walk Test
Evaluation of walking distance on standardized 6 minute walk test
| Study group | Role | What they receive |
|---|---|---|
| Functional Capacity | Experimental | 6 Minute Walk Test Receives: Procedure: 6 Minute Walk Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity (The 6-minute walk test (6MWT))
The 6-minute walk test (6MWT) will be primary measure of functional capacity in these patients.
Measured: Over up to 5 days of from time of hospitalization
Secondary outcomes (1)
30-day readmission rates for heart failure
Exploration of the the relationship between 30-day readmission rates for heart failure and functional capacity.
Measured: 30 days following discharge from Hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Colorado Prevention Center, Cardioxyl Pharmaceuticals, Inc
- Responsible party
- Sponsor
- Investigators
- ShiYin Foo, M.D., PhD., Study director, Cardioxyl Pharmaceiticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350114
- Sponsor's protocol ID
- CXL-AHF-FC01
- Other IDs
- CV013-007
- Status last verified
- Jun 2016
- First submitted
- 18 Jan 2015
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of the Functional Capacity of Heart Failure Patients With Reduced Ejection Fraction Admitted With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT02350114
- Acronym / sponsor ID
- CXL-AHF-FC01
- Conditions
- Acute Heart Failure
- Keywords
- Heart failure, 6 Minute Walk Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Colorado Prevention Center, Cardioxyl Pharmaceuticals, Inc
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Jan 2015 (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.
This is an observational study of the functional capacity of patients with Heart failure with Reduced Ejection Fraction (HFrEF) who are admitted to the hospital for routine medical treatment.
Detailed description
This observational study will evaluate the functional capacity (ability to walk and distance walked) of patients with Heart failure with Reduced Ejection Fraction (HFrEF) in approximately 50-70 patients who present with Acute Heart Failure to approximately 5-6 hospital sites in the USA. All enrolled patients will be evaluated for their baseline functional capacity. Patients will receive standard Acute Heart Failure therapy and will be serially assessed for change in their functional capacity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Capacity | Experimental | Procedure: 6 Minute Walk Test6 Minute Walk Test |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a left ventricular ejection fraction (LVEF) ≤40%, as assessed by any method, e.g., echocardiography, a multigated acquisition (MUGA) scan or magnetic resonance imaging (MRI);
- Present with signs and symptoms considered to be primarily due to AHF and be admitted to the hospital for AHF;
- Confirmation verbally that the patient was ambulatory, i.e., able to walk >30m, prior to developing symptoms of AHF leading to the current admission;
- Be capable of understanding the nature of the trial; be willing and able to comply with the inpatient and outpatient study protocol requirements for the duration of the study; and be willing to participate, as documented by written informed consent.
Key exclusion criteria (8 listed)
- Have a systolic blood pressure <90mmHg or >170mmHg at baseline;
- Have an anticipated need for an invasive procedure within 3 days of study enrollment, e.g., due to hemodynamic or cardiac rhythm instability, or acute coronary syndrome, requiring procedures including, but not limited to, cardiac catheterization, placement of a defibrillator/pacemaker, or placement of a pulmonary artery catheter;
- Have a primary HF etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic cardiomyopathy (as defined by any wall thickness > 1.8cm) that is obstructive, or uncorrected severe valvular disease (except mitral regurgitation);
- Have any other comorbidities that limit ambulation more than the patient's heart failure, e.g., symptomatic peripheral arterial disease, COPD, arthritis or other condition, as confirmed verbally with the patient;
- Have severe renal insufficiency (defined as a GFR <30mL/min/1.73m2 according to the MDRD equation);
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 |
|---|---|---|
| 6 Minute Walk TestAlso: Walk TestEvaluation of walking distance on standardized 6 minute walk test | Procedure or surgery | Functional Capacity |
Primary outcome
Functional Capacity (The 6-minute walk test (6MWT))
Time frame: Over up to 5 days of from time of hospitalization
The 6-minute walk test (6MWT) will be primary measure of functional capacity in these patients.
1 secondary outcome
30-day readmission rates for heart failure
Time frame: 30 days following discharge from Hospital
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 1 Jul 2016.
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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.
ShiYin Foo, M.D., PhD. study director
Cardioxyl Pharmaceiticals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 Minute Walk Test in people with Acute Heart Failure, run by Bristol-Myers Squibb at 6 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 4 inclusion and 8 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 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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?
Functional Capacity (The 6-minute walk test (6MWT)) (time frame: Over up to 5 days of from time of hospitalization). 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 1 Jul 2016.