Partnership Programs for Reducing Cardiovascular Disparities in Native Hawaiians

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Hawaii
ClinicalTrials.gov Identifier:
NCT00101465
First received: January 10, 2005
Last updated: July 2, 2013
Last verified: July 2009
  Purpose

The purpose of this study is to improve cardiovascular disease (CVD) outcomes in racial and ethnic minorities in Hawaii.


Condition
Cardiovascular Diseases
Heart Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Partnership Programs to Reduce Cardiovascular Disparities - Heart Failure Disparities in Native Hawaiians

Resource links provided by NLM:


Further study details as provided by University of Hawaii:

Estimated Enrollment: 276
Study Start Date: September 2004
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants will be a Native Hawaiian or Pacific Islander (e.g., Samoan, Tongan, Tahitian, Maori, Marshallese, etc.)

Criteria

Inclusion Criteria:

  • Clinical symptoms and signs of heart failure AND

    1. Left ventricular systolic ejection fraction of less than 40% OR
    2. Left ventricular systolic ejection fraction of less than 60% AND evidence of abnormal diastolic function confirmed by echocardiogram and documented in the patient's medical record
  • Discharged from a hospital admission for heart failure as a primary or secondary discharge diagnosis within 6 weeks of study entry
  • Self-identified ethnicity/race as Native Hawaiian or Pacific Islander (e.g., Samoan, Tongan, Tahitian, Maori, Marshallese, etc.)

Exclusion criteria

  • Heart failure caused by high-output states (i.e., sepsis, etc.) or transient non-cardiac disease
  • Terminal illnesses in addition to heart failure (e.g., cancer with projected survival of less than 6 months)
  • Currently living in a nursing home
  • Currently undergoing hemodialysis or peritoneal dialysis
  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: NCT00101465

Locations
United States, Hawaii
University of Hawaii at Manoa
Honolulu, Hawaii, United States, 96822
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
University of Hawaii
Investigators
Principal Investigator: Marjorie Mau University of Hawaii at Manoa
Principal Investigator: Todd Seto Queen's Medical Centre
  More Information

No publications provided

Responsible Party: Nobumi Nakamura, University of Hawaii at Manoa
ClinicalTrials.gov Identifier: NCT00101465     History of Changes
Other Study ID Numbers: 1281, U01HL079163, U01 HL79163
Study First Received: January 10, 2005
Last Updated: July 2, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Hawaii:
Heart Failure

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Heart Failure

ClinicalTrials.gov processed this record on July 09, 2014