A Novel Family-Based Intervention Trial to Improve Heart Health - FIT Heart

Nov 19, 2008
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Trial Sponsor:
National Heart, Lung, and Blood Institute
Date Presented:
01/01/2008
Date Published:
01/01/2008
Date Updated:
11/19/2008
Original Posted Date:
11/19/2008
References

Description:

The goal of the trial was to evaluate the family members of a hospitalized cardiac patient and to identify and modify their cardiovascular risk factors.

Hypothesis:

Risk factor modification among family members would be more effective in reducing low-density lipoprotein (LDL) cholesterol.

Study Design

Patients Screened: 3,649
Patients Enrolled: 501
Mean Follow Up: 1 year
Mean Patient Age: Mean 48 years; 12% >65 years
Female: 66%

Patient Populations:

  • Family members or co-habitants of a hospitalized cardiac patient
  • Ages 20-79 years
  • Residence within 3 hours of the hospital

Exclusions:

  • Known diabetes, cardiovascular, liver, or renal disease
  • Current or planned pregnancy
  • Limited life expectancy
  • Prescription of a special diet
  • Participation in another clinical study within the last 3 months
  • Another family member is enrolled in the trial

Primary Endpoints:

  • Percent change in LDL cholesterol

Secondary Endpoints:

  • Change in diet/lifestyle
  • Change in other cardiovascular risk factors

Drug/Procedures Used:

Patients were randomized to special intervention (n = 250) vs. control (n = 251).

Principal Findings:

Overall, 501 patients were randomized. Among the special intervention group, there were 66% women and 32% had a body mass index (BMI) ≥30 kg/m2.

At 1 year, the percent change in LDL cholesterol was -1.0% in the intervention group vs. -2.0% in the control group (p = NS). Within the groups, LDL declined significantly over follow-up; -4.4 mg/dl in the intervention group (p = 0.03) and -4.5 mg/dl in the control group (p = 0.005).

At 1 year, for intervention vs. control, high-density lipoprotein (HDL) cholesterol was 58.7 mg/dl vs. 57.6 mg/dl (p = 0.01), systolic blood pressure was 130 mm Hg vs. 130 mm Hg (p = 0.90), and BMI was 27.7 kg/m2 vs. 28.4 kg/m2 (p = 0.88).

Interpretation:

Among family members of a hospitalized cardiac patient, a special intervention program designed to more comprehensively identify and modify cardiac risk factors is not more effective than a control program in lowering LDL cholesterol. The special intervention group was associated with a slightly higher HDL cholesterol at follow-up.

References:

Mosca L, Mochari H, Liao M, et al. A novel family-based intervention trial to improve heart health: FIT Heart. Circ Cardiovasc Qual Outcomes 2008;1:98-106.

Presented by Dr. Lori Mosca at the American Heart Association Annual Scientific Sessions, New Orleans, November 2008.

Keywords: Coronary Artery Disease, Behavior Therapy, Follow-Up Studies, Body Mass Index, Cholesterol, LDL, Hyperlipidemias, Risk Factors, Cholesterol, HDL, Hypercholesterolemia, Hypertension


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