Heart Failure Adherence and Retention Trial - HART

Sep 21, 2010
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Institutes of Health
Date Published:
01/01/2010
Date Updated:
09/21/2010
Original Posted Date:
09/21/2010
References

Description:

This trial was designed to assess the value of 1 year of self-management counseling on death or heart failure hospitalization in patients with mild to moderate heart failure and reduced or preserved systolic function.

Hypothesis:

Self-management counseling plus heart failure education would be associated with improvements in adherence to drug therapy, sodium restriction, and depression, and thereby, with lower mortality and heart failure hospitalization compared with heart failure education alone in patients with mild to moderate heart failure and reduced or preserved systolic function.

Study Design

  • Parallel
  • Randomized

Patient Populations:

  • Heart failure with preserved or reduced systolic function
  • Active heart failure treatment for a minimum of 3 months

    Number of screened applicants: 3,154
    Number of enrollees: 902
    Duration of follow-up: 1 year
    Mean patient age: 63.6 years
    Percentage female: 47%
    NYHA class: II (68.4%), III (31.6%)

Exclusions:

  • NYHA class I or IV symptoms
  • Reversible causes of heart failure symptoms
  • Uncertain 12-month prognosis
  • Severe medical or psychiatric comorbidities
  • Patient unwillingness to make lifestyle changes
  • Logistic barriers
  • Patient or physician refusal

Primary Endpoints:

  • Death or heart failure hospitalization over 1 year

Secondary Endpoints:

  • All-cause mortality at 1 year
  • Heart failure hospitalizations within 1 year
  • Behavioral treatment targets such as daily sodium consumption and adherence to medications

Drug/Procedures Used:

The self-management plus education treatment featured group-based heart failure education plus counseling to help patients develop mastery in problem-solving skills, and in five self-management skills. Eighteen 2-hour group meetings of approximately 10 patients were spread over the course of 1 year. At each meeting, education in the form of 18 Heart Failure Tip Sheets from the American Heart Association summarized basic elements of patient management, including medication adherence, sudden weight gain, sodium restriction, moderate physical activity, and stress management. Patients randomized to receive education received the same 18 Heart Failure Tip Sheets, on the same schedule as the self-management group meetings, but delivered by mail.

Concomitant Medications:

Angiotensin-converting enzyme inhibitors (ACEI/ARB)/angiotensin-receptor blockers (85.7%), beta-blockers (70.5%)

Principal Findings:

A total of 902 patients were randomized, 451 to the self-management arm, and 451 to the education only arm. Baseline characteristics were fairly similar between the two arms. About 47% were women, and 40% belonged to a minority race, with about 56% having completed education higher than high school. About 23% had preserved left ventricular (LV) function, with New York Heart Association (NYHA) class III symptoms in 32% of the patients, and a median 6-minute walk distance of 252.9 m. The mean number of medications was high (6.8). At baseline, major depressive symptoms were noted in 29.4% of the patients, and the mean Short Form (SF)-36 scores for physical function and vitality were 48.1 and 46.5, respectively.

Over approximately 2.56 years of follow-up, the primary endpoint of death or heart failure hospitalization was similar between the self-management and education arms (40.1% vs. 41.2%, odds ratio [OR] 0.95, 95% confidence interval [CI] 0.72-1.26, p = 0.46). Secondary endpoints such as all-cause mortality (OR 0.87, 95% CI 0.63-1.21), and heart failure hospitalization (OR 1.00, 95% CI 0.72-1.38) were similar between the two arms, as were other endpoints such as change in NYHA class, 6-minute walk distance, and quality of life. Certain parameters such as restricting sodium to ≤2400 mg/day were better in the self-management arm (28% vs. 18%, p = 0.02), although even in the self-management group, sodium intake >2400 mg/day was noted in 72% of the patients at the end of follow-up. In both arms, an increase of 7% was noted in nonadherence to the prescribed dosage of ACEI/ARB or beta-blockers.

Interpretation:

The results of the HART trial indicate that self-management strategies for heart failure management (such as counseling and targeted teaching), with an aim to improve overall patient motivation and involvement, were not superior to routine heart failure education alone in reducing heart failure hospitalizations or mortality in unselected patients with mild to moderate heart failure with normal or reduced LV function. Similar results had been noted in earlier trials, but HART is the largest and the most methodologically rigorous trial on this topic to date.

Trials such as DIAL have demonstrated a salutary effect with interventions such as telephone monitoring, which was not incorporated into the current trial’s design. Meanwhile, other recent trials targeting depression in patients with heart failure (a common association), such as SADHART-CHF, showed no benefit with routine treatment of patients with heart failure and depression with selective serotonin reuptake inhibitors such as sertraline.

References:

Powell LH, Calvin JE, Richardson D, et al. Self-management counseling in patients with heart failure: the Heart Failure Adherence and Retention Randomized Behavioral Trial. JAMA 2010;304:1331-8.

Keywords: Depression, Motivation, Serotonin Uptake Inhibitors, Sodium, Counseling, Weight Gain, Medication Adherence, Sertraline, Self Care, Quality of Life, Heart Failure, Motor Activity, Hospitalization, Postal Service


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