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

This study has been terminated.
(Student related research project. Completion of allotted time.)
Sponsor:
Information provided by (Responsible Party):
Peter Pang, Northwestern University
ClinicalTrials.gov Identifier:
NCT01615926
First received: June 7, 2012
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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
Acute Heart Failure
Dyspnea

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • To determine the association between respiratory rate and self-reported dyspnea in AHF patients. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  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: NCT01615926

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

No publications provided

Responsible Party: Peter Pang, Associate Professor of Emergency Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01615926     History of Changes
Other Study ID Numbers: MSSRP-IC2012
Study First Received: June 7, 2012
Last Updated: April 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
dyspnea
shortness of breath
respiratory rate
orthopnea

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

ClinicalTrials.gov processed this record on August 26, 2014