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An Observational Study of the Functional Capacity of Heart Failure

This study has been completed.
Sponsor:
Collaborators:
Colorado Prevention Center
Cardioxyl Pharmaceuticals, Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02350114
First received: January 18, 2015
Last updated: June 30, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention
Acute Heart Failure
Procedure: 6 Minute Walk Test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: An Observational Study of the Functional Capacity of Heart Failure Patients With Reduced Ejection Fraction Admitted With Acute Heart Failure

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Functional Capacity (The 6-minute walk test (6MWT)) [ Time Frame: Over up to 5 days of from time of hospitalization ] [ Designated as safety issue: No ]
    The 6-minute walk test (6MWT) will be primary measure of functional capacity in these patients.


Secondary Outcome Measures:
  • 30-day readmission rates for heart failure [ Time Frame: 30 days following discharge from Hospital ] [ Designated as safety issue: No ]
    Exploration of the the relationship between 30-day readmission rates for heart failure and functional capacity.


Enrollment: 51
Study Start Date: November 2014
Study Completion Date: July 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Functional Capacity
6 Minute Walk Test
Procedure: 6 Minute Walk Test
Evaluation of walking distance on standardized 6 minute walk test
Other Name: Walk Test

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02350114

Locations
United States, Indiana
Cardioxyl Study Site
Indianapolis, Indiana, United States, 46202
United States, Michigan
Cardioxyl Study Site
Detroit, Michigan, United States, 48202
Cardioxyl Study Site
Detroit, Michigan, United States, 48282
United States, North Carolina
Cardioxyl Study Site
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Cardioxyl Study Site
Cincinnati, Ohio, United States, 45206
United States, Tennessee
Cardioxyl Study Site
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Bristol-Myers Squibb
Colorado Prevention Center
Cardioxyl Pharmaceuticals, Inc
Investigators
Study Director: ShiYin Foo, M.D., PhD. Cardioxyl Pharmaceiticals
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02350114     History of Changes
Other Study ID Numbers: CXL-AHF-FC01  CV013-007 
Study First Received: January 18, 2015
Last Updated: June 30, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Bristol-Myers Squibb:
Heart failure
6 Minute Walk Test

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 25, 2016