An Observational Study of the Functional Capacity of Heart Failure

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.

Study Overview

• Status: Completed
• Conditions: Acute Heart Failure
• Intervention / Treatment: Procedure: 6 Minute 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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Cardioxyl Study Site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Cardioxyl Study Site
    • Detroit, Michigan, United States, 48282
      • Cardioxyl Study Site
  • North Carolina
    • Winston Salem, North Carolina, United States, 27157
      • Cardioxyl Study Site
  • Ohio
    • Cincinnati, Ohio, United States, 45206
      • Cardioxyl Study Site
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Cardioxyl Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional Capacity; 6 Minute Walk Test	Procedure: 6 Minute Walk Test; Evaluation of walking distance on standardized 6 minute walk test; Other Names: Walk Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Capacity (The 6-minute walk test (6MWT))	The 6-minute walk test (6MWT) will be primary measure of functional capacity in these patients.	Over up to 5 days of from time of hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day readmission rates for heart failure	Exploration of the the relationship between 30-day readmission rates for heart failure and functional capacity.	30 days following discharge from Hospital

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Cardioxyl Pharmaceuticals, Inc; Colorado Prevention Center
• Investigators: Study Director: ShiYin Foo, M.D., PhD., Cardioxyl Pharmaceiticals

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: January 18, 2015
• First Submitted That Met QC Criteria: January 28, 2015
• First Posted (Estimate): January 29, 2015

Study Record Updates

• Last Update Posted (Estimate): July 1, 2016
• Last Update Submitted That Met QC Criteria: June 30, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Heart failure; 6 Minute Walk Test
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CXL-AHF-FC01; CV013-007 (Other Identifier: BMS)