An Observational Study of the Functional Capacity of Heart Failure

NCT02350114 | Completed

• 2 other identifiers: CXL-AHF-FC01CV013-007
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Acute Heart Failure

Keywords

Heart failure; 6 Minute Walk Test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 30-day readmission rates for heart failure

  30 days following discharge from Hospital

Study Arms (1)

Functional Capacity

EXPERIMENTAL

6 Minute Walk Test

Procedure: 6 Minute Walk Test

Interventions

6 Minute Walk Test PROCEDURE

Evaluation of walking distance on standardized 6 minute walk test

Also known as: Walk Test

Functional Capacity

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Colorado Prevention Center: collaborator
• Cardioxyl Pharmaceuticals, Inc: collaborator

Study Sites (6)

Cardioxyl Study Site

Indianapolis, Indiana, 46202, United States

Location

Cardioxyl Study Site

Detroit, Michigan, 48202, United States

Location

Cardioxyl Study Site

Detroit, Michigan, 48282, United States

Location

Cardioxyl Study Site

Winston-Salem, North Carolina, 27157, United States

Location

Cardioxyl Study Site

Cincinnati, Ohio, 45206, United States

Location

Cardioxyl Study Site

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• ShiYin Foo, M.D., PhD.

  Cardioxyl Pharmaceiticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2015
• First Posted: January 29, 2015
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 1, 2016

Record last verified: 2016-06

Locations

US (6)