IMPORTANCE: Dapagliflozin has been shown to improve overall health status based on aggregate summary scores of the Kansas City Cardiomyopathy Questionnaire (KCCQ) in patients with heart failure (HF) with mildly reduced or preserved ejection fraction enrolled in the Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure (DELIVER) trial. A comprehensive understanding of the responsiveness of individual KCCQ items would allow clinicians to better inform patients on expected changes in daily living with treatment. OBJECTIVE: To examine the association of dapagliflozin treatment with changes in individual components of the KCCQ. DESIGN, SETTING, AND PARTICIPANTS: This is a post hoc exploratory analysis of DELIVER, a randomized double-blind placebo-controlled trial conducted at 353 centers in 20 countries from August 2018 to March 2022. KCCQ was administered at randomization and 1, 4, and 8 months. Scores of individual KCCQ components were scaled from 0 to 100. Eligibility criteria included symptomatic HF with left ventricular ejection fraction greater than 40%, elevated natriuretic peptide levels, and evidence of structural heart disease. Data were analyzed from November 2022 to February 2023. MAIN OUTCOMES AND MEASURES: Changes in the 23 individual KCCQ components at 8 months. INTERVENTIONS: Dapagliflozin, 10 mg, once daily or placebo. RESULTS: Baseline KCCQ data were available for 5795 of 6263 randomized patients (92.5%) (mean [SD] age, 71.5 [9.5] years; 3344 male [57.7%] and 2451 female [42.3%]). Dapagliflozin was associated with larger improvements in almost all KCCQ components at 8 months compared with placebo. The most significant improvements with dapagliflozin were observed in frequency of lower limb edema (difference, 3.2; 95% CI, 1.6-4.8; P < .001), sleep limitation by shortness of breath (difference, 3.0; 95% CI, 1.6-4.4; P < .001), and limitation in desired activities by shortness of breath (difference, 2.8; 95% CI, 1.3-4.3; P < .001). Similar treatment patterns were observed in longitudinal analyses integrating data from months 1, 4, and 8. Higher proportions of patients treated with dapagliflozin experienced improvements, and fewer had deteriorations across most individual components. CONCLUSIONS AND RELEVANCE: In this study of patients with HF with mildly reduced or preserved ejection fraction, dapagliflozin was associated with improvement in a broad range of individual KCCQ components, with the greatest benefits in domains related to symptom frequency and physical limitations. Potential improvements in specific symptoms and activities of daily living might be more readily recognizable and easily communicated to patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03619213.

British Heart Foundation Glasgow Cardiovascular Research Center School of Cardiovascular and Metabolic Health University of Glasgow Glasgow Scotland United Kingdom

Cardiac Intensive Care Department of Cardiovascular Diseases University Hospitals Leuven Leuven Belgium

Cardiovascular Division Department of Medicine Brigham and Women's Hospital Harvard Medical School Boston Massachusetts

Department of Cardiology Thoraxcenter Erasmus Medical Center Rotterdam the Netherlands

Department of Cardiology University Medical Center Groningen University of Groningen Groningen the Netherlands

Department of Internal Medicine 2 Cardiology and Angiology General University Hospital 1st Medical School Charles University Prague Czech Republic

Division of Cardiology University of Texas Southwestern Medical Center Dallas

Duke University Medical Center Durham North Carolina

Haga Teaching Hospital The Hague the Netherlands

Late Stage Development Cardiovascular Renal and Metabolism BioPharmaceuticals Research and Development AstraZeneca Gothenburg Sweden

National Heart Centre Singapore and Duke National University of Singapore Singapore

Northwestern University Feinberg School of Medicine Chicago Illinois

Saint Luke's Mid America Heart Institute and University of Missouri Kansas City

Universidad Nacional de Córdoba Córdoba Argentina

University of Medicine Pharmacy Science and Technology George Emile Palade Târgu Mureș Romania

Yale School of Medicine New Haven Connecticut

000      

00000naa a2200000 a 4500

001      

bmc23016992

003      

CZ-PrNML

005      

20231026105345.0

007      

ta

008      

231013s2023 xxu f 000 0|eng||

009      

AR

024    7_

$a 10.1001/jamacardio.2023.1342 $2 doi

035    __

$a (PubMed)37208998

040    __

$a ABA008 $b cze $d ABA008 $e AACR2

041    0_

$a eng

044    __

$a xxu

100    1_

$a Peikert, Alexander $u Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts

245    10

$a Association of Dapagliflozin vs Placebo With Individual Kansas City Cardiomyopathy Questionnaire Components in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Secondary Analysis of the DELIVER Trial / $c A. Peikert, A. Chandra, MN. Kosiborod, BL. Claggett, AS. Desai, PS. Jhund, CSP. Lam, SE. Inzucchi, FA. Martinez, RA. de Boer, AF. Hernandez, SJ. Shah, SP. Janssens, J. Belohlávek, CJW. Borleffs, D. Dobreanu, AM. Langkilde, O. Bengtsson, M. Petersson, JJV. McMurray, SD. Solomon, M. Vaduganathan

520    9_

$a IMPORTANCE: Dapagliflozin has been shown to improve overall health status based on aggregate summary scores of the Kansas City Cardiomyopathy Questionnaire (KCCQ) in patients with heart failure (HF) with mildly reduced or preserved ejection fraction enrolled in the Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure (DELIVER) trial. A comprehensive understanding of the responsiveness of individual KCCQ items would allow clinicians to better inform patients on expected changes in daily living with treatment. OBJECTIVE: To examine the association of dapagliflozin treatment with changes in individual components of the KCCQ. DESIGN, SETTING, AND PARTICIPANTS: This is a post hoc exploratory analysis of DELIVER, a randomized double-blind placebo-controlled trial conducted at 353 centers in 20 countries from August 2018 to March 2022. KCCQ was administered at randomization and 1, 4, and 8 months. Scores of individual KCCQ components were scaled from 0 to 100. Eligibility criteria included symptomatic HF with left ventricular ejection fraction greater than 40%, elevated natriuretic peptide levels, and evidence of structural heart disease. Data were analyzed from November 2022 to February 2023. MAIN OUTCOMES AND MEASURES: Changes in the 23 individual KCCQ components at 8 months. INTERVENTIONS: Dapagliflozin, 10 mg, once daily or placebo. RESULTS: Baseline KCCQ data were available for 5795 of 6263 randomized patients (92.5%) (mean [SD] age, 71.5 [9.5] years; 3344 male [57.7%] and 2451 female [42.3%]). Dapagliflozin was associated with larger improvements in almost all KCCQ components at 8 months compared with placebo. The most significant improvements with dapagliflozin were observed in frequency of lower limb edema (difference, 3.2; 95% CI, 1.6-4.8; P < .001), sleep limitation by shortness of breath (difference, 3.0; 95% CI, 1.6-4.4; P < .001), and limitation in desired activities by shortness of breath (difference, 2.8; 95% CI, 1.3-4.3; P < .001). Similar treatment patterns were observed in longitudinal analyses integrating data from months 1, 4, and 8. Higher proportions of patients treated with dapagliflozin experienced improvements, and fewer had deteriorations across most individual components. CONCLUSIONS AND RELEVANCE: In this study of patients with HF with mildly reduced or preserved ejection fraction, dapagliflozin was associated with improvement in a broad range of individual KCCQ components, with the greatest benefits in domains related to symptom frequency and physical limitations. Potential improvements in specific symptoms and activities of daily living might be more readily recognizable and easily communicated to patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03619213.

650    _2

$a lidé $7 D006801

650    _2

$a mužské pohlaví $7 D008297

650    _2

$a ženské pohlaví $7 D005260

650    _2

$a senioři $7 D000368

650    _2

$a tepový objem $7 D013318

650    _2

$a funkce levé komory srdeční $7 D016277

650    _2

$a činnosti denního života $7 D000203

650    _2

$a kvalita života $7 D011788

650    12

$a srdeční selhání $7 D006333

650    _2

$a dyspnoe $7 D004417

650    _2

$a průzkumy a dotazníky $7 D011795

650    12

$a kardiomyopatie $x komplikace $7 D009202

651    _2

$a Kansas $7 D007615

655    _2

$a randomizované kontrolované studie $7 D016449

655    _2

$a časopisecké články $7 D016428

655    _2

$a práce podpořená grantem $7 D013485

700    1_

$a Chandra, Alvin $u Division of Cardiology, University of Texas Southwestern Medical Center, Dallas

700    1_

$a Kosiborod, Mikhail N $u Saint Luke's Mid America Heart Institute and University of Missouri - Kansas City

700    1_

$a Claggett, Brian L $u Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts

700    1_

$a Desai, Akshay S $u Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts

700    1_

$a Jhund, Pardeep S $u British Heart Foundation Glasgow Cardiovascular Research Center, School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, Scotland, United Kingdom

700    1_

$a Lam, Carolyn S P $u National Heart Centre Singapore & Duke-National University of Singapore, Singapore $u Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands

700    1_

$a Inzucchi, Silvio E $u Yale School of Medicine, New Haven, Connecticut

700    1_

$a Martinez, Felipe A $u Universidad Nacional de Córdoba, Córdoba, Argentina

700    1_

$a de Boer, Rudolf A $u Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands

700    1_

$a Hernandez, Adrian F $u Duke University Medical Center, Durham, North Carolina

700    1_

$a Shah, Sanjiv J $u Northwestern University Feinberg School of Medicine, Chicago, Illinois

700    1_

$a Janssens, Stefan P $u Cardiac Intensive Care, Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium

700    1_

$a Belohlávek, Jan $u Department of Internal Medicine II, Cardiology and Angiology, General University Hospital, 1st Medical School, Charles University, Prague, Czech Republic

700    1_

$a Borleffs, C Jan Willem $u Haga Teaching Hospital, The Hague, the Netherlands

700    1_

$a Dobreanu, Dan $u University of Medicine, Pharmacy, Science and Technology, George Emile Palade, Târgu Mureș, Romania

700    1_

$a Langkilde, Anna Maria $u Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden

700    1_

$a Bengtsson, Olof $u Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden

700    1_

$a Petersson, Magnus $u Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden

700    1_

$a McMurray, John J V $u British Heart Foundation Glasgow Cardiovascular Research Center, School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, Scotland, United Kingdom

700    1_

$a Solomon, Scott D $u Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts

700    1_

$a Vaduganathan, Muthiah $u Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts

773    0_

$w MED00191356 $t JAMA cardiology $x 2380-6591 $g Roč. 8, č. 7 (2023), s. 684-690

856    41

$u https://pubmed.ncbi.nlm.nih.gov/37208998 $y Pubmed

910    __

$a ABA008 $b sig $c sign $y - $z 0

990    __

$a 20231013 $b ABA008

991    __

$a 20231026105339 $b ABA008

999    __

$a ok $b bmc $g 2000486 $s 1203354

BAS    __

$a 3

BAS    __

$a PreBMC-MEDLINE

BMC    __

$a 2023 $b 8 $c 7 $d 684-690 $e 2023Jul01 $i 2380-6591 $m JAMA cardiology $n JAMA Cardiol $x MED00191356

LZP    __

$a Pubmed-20231013