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Impact of Spironolactone on Longitudinal Changes in Health-Related Quality of Life in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial.
Circ Heart Fail. 2016 Mar; 9(3):e001937.CH

Abstract

BACKGROUND

Heart failure (HF) with preserved ejection fraction patients have equally impaired health-related quality of life (HRQL) compared with those with HF with reduced ejection fraction, but limited studies have evaluated the impact of therapies on changes in HRQL.

METHODS AND RESULTS

Patients ≥50 years of age, with symptomatic HF and left ventricular ejection fraction ≥45%, were enrolled in Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) and randomized to spironolactone or placebo. Patients completed the Kansas City Cardiomyopathy Questionnaire (KCCQ), which was the primary HRQL instrument, and EQ5D visual analog scale at baseline, 4 months, 12 months, and annually thereafter. McMaster Overall Treatment Evaluation was assessed at 4 and 12 months to assess global change scores. Change scores (+SD) were calculated to determine between-group differences, and multivariable repeated-measures models were created to identify other factors associated with change scores. Paired KCCQ data were available for 91.7% of 3445 TOPCAT patients. By 4 months, the mean change in KCCQ was 7.7±16 and mean change in EQ5D visual analog scale was 4.7±16. Adjusted mean changes in KCCQ for the spironolactone group were significantly better than those for the placebo group at 4-month (1.54 better; P=0.002), 12-month (1.35 better; P=0.02), and 36-month (1.86 better; P=0.02) visits. No between-group differences in EQ5D visual analog scale change scores or McMaster Overall Treatment Evaluation were noted. Older age, obesity, current smoking, New York Heart Association class III/IV, and comorbid illnesses were associated with declines in KCCQ scores. Use of spironolactone was an independent predictor of improved KCCQ scores.

CONCLUSIONS

In symptomatic HF with preserved ejection fraction patients, use of spironolactone was associated with an improvement in HF-specific HRQL. Several modifiable risk factors were associated with HRQL deterioration.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00094302.

Authors+Show Affiliations

From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (E.F.L., B.C., S.D.S., A.S.D., M.A.P.); New England Research Institutes, Watertown, MA (H.-Y.K., S.F.A., C.T.K., S.A.M.); Mid America Heart Institute/UMKC, Kansas City, MO (J.S.); Division of Cardiology, New York Methodist Hospital, Brooklyn (J.F.H.); University of Utah, Division of Cardiology, Salt Lake City (J.C.F.); and University of Michigan School of Medicine, Ann Arbor (B.A.P.). eflewis@partners.org.From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (E.F.L., B.C., S.D.S., A.S.D., M.A.P.); New England Research Institutes, Watertown, MA (H.-Y.K., S.F.A., C.T.K., S.A.M.); Mid America Heart Institute/UMKC, Kansas City, MO (J.S.); Division of Cardiology, New York Methodist Hospital, Brooklyn (J.F.H.); University of Utah, Division of Cardiology, Salt Lake City (J.C.F.); and University of Michigan School of Medicine, Ann Arbor (B.A.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (E.F.L., B.C., S.D.S., A.S.D., M.A.P.); New England Research Institutes, Watertown, MA (H.-Y.K., S.F.A., C.T.K., S.A.M.); Mid America Heart Institute/UMKC, Kansas City, MO (J.S.); Division of Cardiology, New York Methodist Hospital, Brooklyn (J.F.H.); University of Utah, Division of Cardiology, Salt Lake City (J.C.F.); and University of Michigan School of Medicine, Ann Arbor (B.A.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (E.F.L., B.C., S.D.S., A.S.D., M.A.P.); New England Research Institutes, Watertown, MA (H.-Y.K., S.F.A., C.T.K., S.A.M.); Mid America Heart Institute/UMKC, Kansas City, MO (J.S.); Division of Cardiology, New York Methodist Hospital, Brooklyn (J.F.H.); University of Utah, Division of Cardiology, Salt Lake City (J.C.F.); and University of Michigan School of Medicine, Ann Arbor (B.A.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (E.F.L., B.C., S.D.S., A.S.D., M.A.P.); New England Research Institutes, Watertown, MA (H.-Y.K., S.F.A., C.T.K., S.A.M.); Mid America Heart Institute/UMKC, Kansas City, MO (J.S.); Division of Cardiology, New York Methodist Hospital, Brooklyn (J.F.H.); University of Utah, Division of Cardiology, Salt Lake City (J.C.F.); and University of Michigan School of Medicine, Ann Arbor (B.A.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (E.F.L., B.C., S.D.S., A.S.D., M.A.P.); New England Research Institutes, Watertown, MA (H.-Y.K., S.F.A., C.T.K., S.A.M.); Mid America Heart Institute/UMKC, Kansas City, MO (J.S.); Division of Cardiology, New York Methodist Hospital, Brooklyn (J.F.H.); University of Utah, Division of Cardiology, Salt Lake City (J.C.F.); and University of Michigan School of Medicine, Ann Arbor (B.A.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (E.F.L., B.C., S.D.S., A.S.D., M.A.P.); New England Research Institutes, Watertown, MA (H.-Y.K., S.F.A., C.T.K., S.A.M.); Mid America Heart Institute/UMKC, Kansas City, MO (J.S.); Division of Cardiology, New York Methodist Hospital, Brooklyn (J.F.H.); University of Utah, Division of Cardiology, Salt Lake City (J.C.F.); and University of Michigan School of Medicine, Ann Arbor (B.A.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (E.F.L., B.C., S.D.S., A.S.D., M.A.P.); New England Research Institutes, Watertown, MA (H.-Y.K., S.F.A., C.T.K., S.A.M.); Mid America Heart Institute/UMKC, Kansas City, MO (J.S.); Division of Cardiology, New York Methodist Hospital, Brooklyn (J.F.H.); University of Utah, Division of Cardiology, Salt Lake City (J.C.F.); and University of Michigan School of Medicine, Ann Arbor (B.A.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (E.F.L., B.C., S.D.S., A.S.D., M.A.P.); New England Research Institutes, Watertown, MA (H.-Y.K., S.F.A., C.T.K., S.A.M.); Mid America Heart Institute/UMKC, Kansas City, MO (J.S.); Division of Cardiology, New York Methodist Hospital, Brooklyn (J.F.H.); University of Utah, Division of Cardiology, Salt Lake City (J.C.F.); and University of Michigan School of Medicine, Ann Arbor (B.A.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (E.F.L., B.C., S.D.S., A.S.D., M.A.P.); New England Research Institutes, Watertown, MA (H.-Y.K., S.F.A., C.T.K., S.A.M.); Mid America Heart Institute/UMKC, Kansas City, MO (J.S.); Division of Cardiology, New York Methodist Hospital, Brooklyn (J.F.H.); University of Utah, Division of Cardiology, Salt Lake City (J.C.F.); and University of Michigan School of Medicine, Ann Arbor (B.A.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (E.F.L., B.C., S.D.S., A.S.D., M.A.P.); New England Research Institutes, Watertown, MA (H.-Y.K., S.F.A., C.T.K., S.A.M.); Mid America Heart Institute/UMKC, Kansas City, MO (J.S.); Division of Cardiology, New York Methodist Hospital, Brooklyn (J.F.H.); University of Utah, Division of Cardiology, Salt Lake City (J.C.F.); and University of Michigan School of Medicine, Ann Arbor (B.A.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (E.F.L., B.C., S.D.S., A.S.D., M.A.P.); New England Research Institutes, Watertown, MA (H.-Y.K., S.F.A., C.T.K., S.A.M.); Mid America Heart Institute/UMKC, Kansas City, MO (J.S.); Division of Cardiology, New York Methodist Hospital, Brooklyn (J.F.H.); University of Utah, Division of Cardiology, Salt Lake City (J.C.F.); and University of Michigan School of Medicine, Ann Arbor (B.A.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (E.F.L., B.C., S.D.S., A.S.D., M.A.P.); New England Research Institutes, Watertown, MA (H.-Y.K., S.F.A., C.T.K., S.A.M.); Mid America Heart Institute/UMKC, Kansas City, MO (J.S.); Division of Cardiology, New York Methodist Hospital, Brooklyn (J.F.H.); University of Utah, Division of Cardiology, Salt Lake City (J.C.F.); and University of Michigan School of Medicine, Ann Arbor (B.A.P.).No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

26962133

Citation

Lewis, Eldrin F., et al. "Impact of Spironolactone On Longitudinal Changes in Health-Related Quality of Life in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial." Circulation. Heart Failure, vol. 9, no. 3, 2016, pp. e001937.
Lewis EF, Kim HY, Claggett B, et al. Impact of Spironolactone on Longitudinal Changes in Health-Related Quality of Life in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial. Circ Heart Fail. 2016;9(3):e001937.
Lewis, E. F., Kim, H. Y., Claggett, B., Spertus, J., Heitner, J. F., Assmann, S. F., Kenwood, C. T., Solomon, S. D., Desai, A. S., Fang, J. C., McKinlay, S. A., Pitt, B. A., & Pfeffer, M. A. (2016). Impact of Spironolactone on Longitudinal Changes in Health-Related Quality of Life in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial. Circulation. Heart Failure, 9(3), e001937. https://doi.org/10.1161/CIRCHEARTFAILURE.114.001937
Lewis EF, et al. Impact of Spironolactone On Longitudinal Changes in Health-Related Quality of Life in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial. Circ Heart Fail. 2016;9(3):e001937. PubMed PMID: 26962133.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Impact of Spironolactone on Longitudinal Changes in Health-Related Quality of Life in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial. AU - Lewis,Eldrin F, AU - Kim,Hae-Young, AU - Claggett,Brian, AU - Spertus,John, AU - Heitner,John F, AU - Assmann,Susan F, AU - Kenwood,Christopher T, AU - Solomon,Scott D, AU - Desai,Akshay S, AU - Fang,James C, AU - McKinlay,Sonia A, AU - Pitt,Bertram A, AU - Pfeffer,Marc A, AU - ,, PY - 2016/3/11/entrez PY - 2016/3/11/pubmed PY - 2016/7/7/medline KW - clinical trial KW - heart failure KW - predictors KW - preserved ejection fraction KW - quality of life SP - e001937 EP - e001937 JF - Circulation. Heart failure JO - Circ Heart Fail VL - 9 IS - 3 N2 - BACKGROUND: Heart failure (HF) with preserved ejection fraction patients have equally impaired health-related quality of life (HRQL) compared with those with HF with reduced ejection fraction, but limited studies have evaluated the impact of therapies on changes in HRQL. METHODS AND RESULTS: Patients ≥50 years of age, with symptomatic HF and left ventricular ejection fraction ≥45%, were enrolled in Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) and randomized to spironolactone or placebo. Patients completed the Kansas City Cardiomyopathy Questionnaire (KCCQ), which was the primary HRQL instrument, and EQ5D visual analog scale at baseline, 4 months, 12 months, and annually thereafter. McMaster Overall Treatment Evaluation was assessed at 4 and 12 months to assess global change scores. Change scores (+SD) were calculated to determine between-group differences, and multivariable repeated-measures models were created to identify other factors associated with change scores. Paired KCCQ data were available for 91.7% of 3445 TOPCAT patients. By 4 months, the mean change in KCCQ was 7.7±16 and mean change in EQ5D visual analog scale was 4.7±16. Adjusted mean changes in KCCQ for the spironolactone group were significantly better than those for the placebo group at 4-month (1.54 better; P=0.002), 12-month (1.35 better; P=0.02), and 36-month (1.86 better; P=0.02) visits. No between-group differences in EQ5D visual analog scale change scores or McMaster Overall Treatment Evaluation were noted. Older age, obesity, current smoking, New York Heart Association class III/IV, and comorbid illnesses were associated with declines in KCCQ scores. Use of spironolactone was an independent predictor of improved KCCQ scores. CONCLUSIONS: In symptomatic HF with preserved ejection fraction patients, use of spironolactone was associated with an improvement in HF-specific HRQL. Several modifiable risk factors were associated with HRQL deterioration. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00094302. SN - 1941-3297 UR - https://www.unboundmedicine.com/medline/citation/26962133/Impact_of_Spironolactone_on_Longitudinal_Changes_in_Health_Related_Quality_of_Life_in_the_Treatment_of_Preserved_Cardiac_Function_Heart_Failure_With_an_Aldosterone_Antagonist_Trial_ L2 - http://www.ahajournals.org/doi/full/10.1161/CIRCHEARTFAILURE.114.001937?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -