NCT00101465

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2004

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2005

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

July 3, 2013

Status Verified

July 1, 2009

Enrollment Period

6.9 years

First QC Date

January 10, 2005

Last Update Submit

July 2, 2013

Conditions

Cardiovascular DiseasesHeart Diseases

Keywords

Heart Failure

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Clinical symptoms and signs of heart failure AND
  • Left ventricular systolic ejection fraction of less than 40% OR
  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

University of Hawaii at Manoa

Honolulu, Hawaii, 96822, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHeart Failure

Study Officials

  • Marjorie Mau

    University of Hawaii at Manoa

    PRINCIPAL INVESTIGATOR

  • Todd Seto

    Queen's Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2005

First Posted

January 11, 2005

Study Start

September 1, 2004

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

July 3, 2013

Record last verified: 2009-07

Locations

US(2)