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Effect of Treatment With Sacubitril/Valsartan in Patients With Advanced Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial.
Mann, Douglas L; Givertz, Michael M; Vader, Justin M; Starling, Randall C; Shah, Palak; McNulty, Steven E; Anstrom, Kevin J; Margulies, Kenneth B; Kiernan, Michael S; Mahr, Claudius; Gupta, Divya; Redfield, Margaret M; Lala, Anuradha; Lewis, Gregory D; DeVore, Adam D; Desvigne-Nickens, Patrice; Hernandez, Adrian F; Braunwald, Eugene.
  • Mann DL; Department of Medicine, Washington University in St Louis, St Louis, Missouri.
  • Givertz MM; Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
  • Vader JM; Department of Medicine, Washington University in St Louis, St Louis, Missouri.
  • Starling RC; Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
  • Shah P; Inova Heart and Vascular Institute, Falls Church, Virginia.
  • McNulty SE; Duke Clinical Research Institute, Duke University, Durham, North Carolina.
  • Anstrom KJ; Duke Clinical Research Institute, Duke University, Durham, North Carolina.
  • Margulies KB; Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
  • Kiernan MS; Department of Medicine, Tufts Medical Center, Boston, Massachusetts.
  • Mahr C; Department of Medicine, University of Washington, Seattle.
  • Gupta D; Department of Medicine, Emory University, Atlanta, Georgia.
  • Redfield MM; Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.
  • Lala A; Icahn School of Medicine at Mount Sinai, New York, New York.
  • Lewis GD; Department of Medicine, Massachusetts General Hospital, Boston.
  • DeVore AD; Duke Clinical Research Institute, Duke University, Durham, North Carolina.
  • Desvigne-Nickens P; Department of Medicine, Duke University, Durham, North Carolina.
  • Hernandez AF; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Baltimore, Maryland.
  • Braunwald E; Duke Clinical Research Institute, Duke University, Durham, North Carolina.
JAMA Cardiol ; 7(1): 17-25, 2022 01 01.
Article in English | MEDLINE | ID: covidwho-1499191
ABSTRACT
Importance The use of sacubitril/valsartan is not endorsed by practice guidelines for use in patients with New York Heart Association class IV heart failure with a reduced ejection fraction because of limited clinical experience in this population.

Objective:

To compare treatment with sacubitril/valsartan treatment with valsartan in patients with advanced heart failure and a reduced ejection fraction and recent New York Heart Association class IV symptoms. Design, Setting, and

Participants:

A double-blind randomized clinical trial was conducted; a total of 335 patients with advanced heart failure were included. The trial began on March 2, 2017, and was stopped early on March 23, 2020, owing to COVID-19 risk. Intervention Patients were randomized to receive sacubitril/valsartan (target dose, 200 mg twice daily) or valsartan (target dose, 160 mg twice daily) in addition to recommended therapy. Main Outcomes and

Measures:

The area under the curve (AUC) for the ratio of N-terminal pro-brain natriuretic peptide (NT-proBNP) compared with baseline measured through 24 weeks of therapy.

Results:

Of the 335 patients included in the analysis, 245 were men (73%); mean (SD) age was 59.4 (13.5) years. Seventy-two eligible patients (18%) were not able to tolerate sacubitril/valsartan, 100 mg/d, during the short run-in period, and 49 patients (29%) discontinued sacubitril/valsartan during the 24 weeks of the trial. The median NT-proBNP AUC for the valsartan treatment arm (n = 168) was 1.19 (IQR, 0.91-1.64), whereas the AUC for the sacubitril/valsartan treatment arm (n = 167) was 1.08 (IQR, 0.75-1.60). The estimated ratio of change in the NT-proBNP AUC was 0.95 (95% CI 0.84-1.08; P = .45). Compared with valsartan, treatment with sacubitril/valsartan did not improve the clinical composite of number of days alive, out of hospital, and free from heart failure events. Aside from a statistically significant increase in non-life-threatening hyperkalemia in the sacubitril/valsartan arm (28 [17%] vs 15 [9%]; P = .04), there were no observed safety concerns. Conclusions and Relevance The findings of this trial showed that, in patients with chronic advanced heart failure with a reduced ejection fraction, there was no statistically significant difference between sacubitril/valsartan and valsartan with respect to reducing NT-proBNP levels. Trial Registration ClinicalTrials.gov Identifier NCT02816736.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Biphenyl Compounds / Angiotensin Receptor Antagonists / Valsartan / Aminobutyrates / Heart Failure Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Female / Humans / Male / Middle aged Language: English Journal: JAMA Cardiol Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Biphenyl Compounds / Angiotensin Receptor Antagonists / Valsartan / Aminobutyrates / Heart Failure Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Female / Humans / Male / Middle aged Language: English Journal: JAMA Cardiol Year: 2022 Document Type: Article