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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01615926
Recruitment Status : Terminated (Student related research project. Completion of allotted time.)
First Posted : June 11, 2012
Last Update Posted : May 1, 2013
Information provided by (Responsible Party):
Peter Pang, Northwestern University

Brief Summary:
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.

Condition or disease
Acute Heart Failure Dyspnea

Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of The Clinical Course of Dyspnea and Its Association With Respiratory Rate in Patients With Acute Heart Failure Syndromes
Study Start Date : June 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. To determine the association between respiratory rate and self-reported dyspnea in AHF patients. [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients who present to the Emergency Department with Acute Heart Failure

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01615926

United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: Peter S Pang, MD Northwestern University

Responsible Party: Peter Pang, Associate Professor of Emergency Medicine, Northwestern University Identifier: NCT01615926     History of Changes
Other Study ID Numbers: MSSRP-IC2012
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: May 1, 2013
Last Verified: April 2013

Keywords provided by Peter Pang, Northwestern University:
shortness of breath
respiratory rate

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms