Status:
COMPLETED
Heart to Health: A Combined Lifestyle and Medication Intervention to Reduce Cardiovascular Disease (CVD) Risk
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Cardiovascular Disease
Coronary Heart Disease
Eligibility:
All Genders
35-79 years
Phase:
NA
Brief Summary
Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of death in the US. Every year, more than one million Americans have a heart attack, and nearly 800,000 have a st...
Eligibility Criteria
Inclusion
- Established patients
- Men ages 35-79
- Women ages 45-79
- History of CVD (100 participants)
- CHD risk equal or greater than 10%
- elevated CHD risk factor
Exclusion
- non-English speaking
- no phone
- treatment of psychosis
- history of alcohol/substance abuse within last 2 years
- pregnancy, breast feeding, or anticipated pregnancy in next 18 months
- history of malignancy, other than non-melanoma skin cancer, that has not been in remission or cured surgically for \>5 years
- recent history (in past year) of hypoglycemic event requiring medical attention
- estimated creatinine clearance less than 30 ml/min
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
489 Patients enrolled
Trial Details
Trial ID
NCT01245686
Start Date
February 1 2011
End Date
November 1 2012
Last Update
February 6 2013
Active Locations (5)
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1
Durham Family Practice
Durham, North Carolina, United States, 27704
2
Dayspring Family Medicine
Eden, North Carolina, United States, 27288
3
Cabarrus Family Medicine Residency
Kannapolis, North Carolina, United States, 28081
4
Moncure Community Health Center
Moncure, North Carolina, United States, 27559