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FIT Heart: Special interventions did not result in better LDL reductions in family members of patients with CVD
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The FIT Heart trial failed to show that intervention including on-the-spot risk factor screening and diet and exercise counseling helped relatives of hospitalized patients lower their LDL levels any more than giving them a handout.
However, the relatives of patients hospitalized with cardiovascular diseases improved their lifestyle and lowered some risk factors after participating in a hospital-based systems approach to health screening and lifestyle counseling.
Although participants in the special intervention and study control groups both experienced significant improvement in LDL levels (-4.4 mg/dL; P=0.03 in special intervention group vs. -4.5 mg/dL, P=0.005 in control group), there was no difference between the two groups in lowering LDL (P=0.64), which was the primary endpoint of the trial. Lori Mosca, MD, PhD, MPH, professor of medicine at Columbia University Medical Center and director of preventive cardiology at New York-Presbyterian Hospital, presented the trial during a late-breaking clinical trial session at the American Heart Association’s Scientific Sessions 2008 in New Orleans.
“If our target is LDL cholesterol, we need to have a more intensive intervention than what we employed in this study in order to reduce significantly LDL beyond the spontaneous changes that the participants were able to achieve.”
Mosca said that the special interventions compared with the control group had a better impact on family members’ diet (P=0.04) and improvement in HDL level (P=0.01), secondary endpoints of the study.
“I would suggest that future guideline committees consider adding documentation of recommendations for screening and referral as necessary among family members of cardiac patients,” Mosca said.
Family members in the special intervention group (n=250) received an on-the-spot risk factor screening with immediate feedback and a year of diet and exercise counseling from bilingual health educators who sent progress reports to physicians. Family members in the control group (n=251) received a general handout about risk factor reduction. Sixty-six percent of the participants were women.
Mosca said that the special interventions group was most likely to exercise more than three times a week at one-year follow-up compared with the control group. Additional findings showed that the 39% of people with high LDL and 39% with high BP reported no history or awareness of problems in cholesterol or hypertension. – by Judith Rusk
For more information:
- Mosca L. A novel family-based intervention trial to improve heart health (FIT Heart): Results of a randomized controlled trial. LBCT IV. Presented at: AHA Scientific Sessions 2008; Nov. 8-12; New Orleans.
This is a good primary prevention lifestyle trial that involved excellent recruitment and retention. They had a high, almost 70% representation of women. We can no longer blame the ‘victim’ for the absence of women in clinical trials. When we make these trials female-friendly, they do come.
Dr. Mosca has demonstrated – and these data support – the use of teachable moments, similar to prior trials that demonstrated post-MI smoking cessation as well as a wealth of secondary prevention…these teachable moments definitely need to translate into practice. But realistically, it was a negative trial. So what have we learned? The environment is critical…individual willpower, which was tested in this trial, will be insufficient on average. Interventions must simultaneously focus on the environment. Number two, there were minimal group differences…Knowledge alone is inadequate for measurable risk factor change. Interventions and screening can intensify risk factor management [and] make measurable differences in integrated health care systems.
– C. Noel Bairey-Merz, MD
Cardiology Today Editorial Board member