Health status across major subgroups of patients with heart failure and preserved ejection fraction

Author:

Siddiqi Tariq Jamal1,Anker Stefan D.234,Filippatos Gerasimos5,Ferreira João Pedro6789,Pocock Stuart J.10,Böhm Michael11,Brueckmann Martina1213,Chopra Vijay K.14,Iwata Tomoko15,Januzzi James16,Piña Ileana L.17,Ponikowski Piotr18,Senni Michele19,Vedin Ola20,Verma Subodh21,Zhang Yuhui22,Zannad Faiez23,Packer Milton2425,Butler Javed126

Affiliation:

1. Department of Medicine University of Mississippi Medical Center Jackson MS USA

2. Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies Berlin Germany

3. German Centre for Cardiovascular Research partner site Berlin Germany

4. Charité Universitätsmedizin Berlin Germany

5. National and Kapodistrian University of Athens School of Medicine Athens University Hospital Attikon Chaidari Greece

6. UnIC@RISE, Cardiovascular Research and Development Center, Department of Surgery and Physiology, Faculty of Medicine University of Porto Porto Portugal

7. Heart Failure Clinic, Internal Medicine Department Centro Hospitalar de Vila Nova de Gaia/Espinho Portugal

8. Inserm, Centre d'Investigations Cliniques ‐ Plurithématique 14‐33 Université de Lorraine Nancy France

9. Inserm U1116, CHRU Nancy, F‐CRIN INI‐CRCT (Cardiovascular and Renal Clinical Trialists) Nancy France

10. Department of Medical Statistics London School of Hygiene and Tropical Medicine London UK

11. Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes Saarland University Homburg/Saar Germany

12. Boehringer Ingelheim International GmbH Ingelheim Germany

13. First Department of Medicine, Faculty of Medicine Mannheim University of Heidelberg Mannheim Germany

14. Max Superspeciality Hospital, Saket New Delhi India

15. Boehringer Ingelheim Pharma GmbH & Co. KG Biberach Germany

16. Massachusetts General Hospital and Baim Institute for Clinical Research Boston MA USA

17. Central Michigan University Mount Pleasant MI USA

18. Wroclaw Medical University Wroclaw Poland

19. Cardiology Division, Cardiovascular Department Papa Giovanni XXIII Hospital Bergamo Italy

20. Boehringer Ingelheim AB Stockholm Sweden

21. Division of Cardiac Surgery, St. Michael's Hospital University of Toronto Toronto ON Canada

22. Heart Failure Center, Fuwai Hospital, Chinese Academy of Medical Science and Peking Union Medical College Beijing China

23. Centre d'Investigations Cliniques Plurithématique 1433 and Inserm U1116, CHRU, FCRIN INI‐CRCT (Cardiovascular and Renal Clinical Trialists) Université de Lorraine Nancy France

24. Baylor Heart and Vascular Institute Baylor University Medical Center Dallas TX USA

25. Imperial College London UK

26. Baylor Scott and White Research Institute Dallas TX USA

Abstract

AimsThere are limited data on health status and changes in it over time across major subgroups of patients with heart failure and preserved ejection fraction (HFpEF), including ejection fraction spectrum, age, sex, region, body mass index (BMI), and comorbidities including diabetes, chronic kidney disease (CKD), anaemia, and atrial fibrillation/flutter.Methods and resultsIn the EMPEROR‐Preserved trial, the Kansas City Cardiomyopathy Questionnaire (KCCQ) was assessed at baseline, 12, 32 and 52 weeks. Determinants of baseline KCCQ score and change over time, and the impact of empagliflozin on KCCQ scores were studied in specified subgroups. A Cox model was used to assess the association between 5‐ and 10‐point increase and 5‐point decrease in KCCQ score from baseline to week 12 and later outcomes. Among 2979 participants in the placebo arm, mean KCCQ clinical summary score (CSS) was 70.7 (20.8). Older age, female sex, BMI, anaemia, and a history of diabetes, and CKD were associated with worse scores. KCCQ‐CSS score improved during follow‐up; patients with atrial fibrillation/flutter at enrollment (p trend = 0.014) and CKD (p trend < 0.001) had less improvement. A 5‐point increase in KCCQ‐CSS at week 12 was associated with lower risk of cardiovascular death or heart failure hospitalization (5%), cardiovascular death (8%), and first heart failure hospitalization (4%) subsequently. A similar trend was seen with KCCQ total symptom score (TSS) and overall summary score (OSS). Empagliflozin improved KCCQ‐CSS, ‐TSS and ‐OSS scores similarly across subgroups studied except for greater improvement in patients with the highest BMI (p trend = 0.153, 0.08 and 0.078, respectively).ConclusionHealth status in patients with HFpEF is impaired, especially in elderly, women, and those with obesity and comorbidities. Empagliflozin improved health status among all key subgroups studied with a greater effect in obese patients.

Funder

Boehringer Ingelheim

Eli Lilly and Company

Publisher

Wiley

Subject

Cardiology and Cardiovascular Medicine

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