Assessment of The Clinical Course of Dyspnea in Acute Heart Failure Patients

Assessment of The Clinical Course of Dyspnea and Its Association With Respiratory Rate in Patients With Acute Heart Failure Syndromes

Acute heart failure (AHF) is defined as a gradual or rapid change in heart failure (HF) signs and symptoms, such as shortness of breath (also called dyspnea or breathlessness), leg swelling, fatigue, breathlessness with exertion, trouble sleeping flat at night, and weight gain resulting in a need for urgent therapy. AHF results in over 1 million hospitalizations every year, resulting in an enormous public health burden. Approximately 1/3rd of patients will either be re-hospitalized or die within three months, and the resultant financial costs are large. As such, improving outcomes for AHF patients is critically important. Shortness of breath is the most common reason why patients with AHF present to the ER. As such, understanding how severe this symptom is, how much it improves with current treatments is very important to both patients and physicians. The purpose of this study is to determine the degree to which your shortness of breath improves during the first few days of hospitalization and its association with how fast you are breathing.

Study Overview

• Status: Terminated
• Conditions: Dyspnea; Acute Heart Failure

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who present to the Emergency Department with Acute Heart Failure

Description

Inclusion Criteria:

• Male or female ≥ 18 years of age
• AHFS is the primary working diagnosis for ER management and treatment with planned admission
• Have received IV diuretic therapy
• Enrolled within 3 hours of initial diuretic dose

Exclusion Criteria:

• BNP level is ≤ 300 pg/mL (may be initially enrolled and then will be excluded for second assessment)
• Transplant recipients of any kind
• Fever > 101.5
• Severe lung disease (required home O2 or daily oral steroids)
• Any ACS event within last 30 days
• Life expectancy less than 12 months for any reason
• Current treatment for any malignancy of any kind
• Cardiogenic shock and/or requiring IV inotropic therapy
• Pregnant or recently pregnant within last 90 days
• Inability to give appropriate written consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the association between respiratory rate and self-reported dyspnea in AHF patients.	24 hours

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Peter S Pang, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: June 7, 2012
• First Submitted That Met QC Criteria: June 7, 2012
• First Posted (Estimate): June 11, 2012

Study Record Updates

• Last Update Posted (Estimate): May 1, 2013
• Last Update Submitted That Met QC Criteria: April 30, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: respiratory rate; dyspnea; orthopnea; shortness of breath
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Heart Failure; Dyspnea
• Other Study ID Numbers: MSSRP-IC2012