• Something wrong with this record ?

Rationale and Design of the Dapagliflozin Effect on Cardiovascular Events in Acute Heart Failure (DAPA ACT HF)-TIMI 68 Trial

DD. Berg, SM. Patel, PM. Haller, J. Bělohlávek, AS. Desai, J. Drożdż, SE. Inzucchi, JJV. McMurray, B. Merkely, E. O'Meara, S. Verma, AL. Cange, SA. Murphy, MS. Sabatine, SD. Wiviott

. 2025 ; 13 (5) : 829-839. [pub] -

Language English Country United States

Document type Clinical Trial Protocol, Journal Article

Persistent link   https://www.medvik.cz/link/bmc25015831

Although sodium-glucose cotransporter 2 inhibitors reduce the risk of cardiovascular death or worsening heart failure (HF) in patients with chronic HF, there are limited data on initiation in hospitalized patients with HF. DAPA ACT HF-TIMI 68 (Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure - Thrombolysis in Myocardial Infarction 68) is an international, randomized, double-blind trial evaluating the initiation of dapagliflozin (10 mg daily) vs placebo in 2,401 patients hospitalized for acute HF. Patients were enrolled irrespective of left ventricular ejection fraction, type 2 diabetes status, or chronicity of HF (de novo and worsening chronic HF). Randomized participants receive blinded treatment for 2 months. The primary efficacy endpoint is time to first occurrence of cardiovascular death or worsening HF (worsening HF during the index admission, rehospitalization for worsening HF, or urgent HF visit). Key safety endpoints include symptomatic hypotension and worsening kidney function. This is the first cardiovascular outcomes trial designed specifically to evaluate the efficacy and safety of in-hospital initiation of dapagliflozin in patients hospitalized for the management of acute HF. (Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure - Thrombolysis in Myocardial Infarction 68 [DAPA ACT HF-TIMI 68]; NCT04363697; EudraCT # 2022-001262-35).

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc25015831
003      
CZ-PrNML
005      
20250731091245.0
007      
ta
008      
250708s2025 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1016/j.jchf.2025.03.014 $2 doi
035    __
$a (PubMed)40335233
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Berg, David D $u TIMI Study Group, Brigham and Women's Hospital, Boston, Massachusetts, USA; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: dberg1@bwh.harvard.edu
245    10
$a Rationale and Design of the Dapagliflozin Effect on Cardiovascular Events in Acute Heart Failure (DAPA ACT HF)-TIMI 68 Trial / $c DD. Berg, SM. Patel, PM. Haller, J. Bělohlávek, AS. Desai, J. Drożdż, SE. Inzucchi, JJV. McMurray, B. Merkely, E. O'Meara, S. Verma, AL. Cange, SA. Murphy, MS. Sabatine, SD. Wiviott
520    9_
$a Although sodium-glucose cotransporter 2 inhibitors reduce the risk of cardiovascular death or worsening heart failure (HF) in patients with chronic HF, there are limited data on initiation in hospitalized patients with HF. DAPA ACT HF-TIMI 68 (Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure - Thrombolysis in Myocardial Infarction 68) is an international, randomized, double-blind trial evaluating the initiation of dapagliflozin (10 mg daily) vs placebo in 2,401 patients hospitalized for acute HF. Patients were enrolled irrespective of left ventricular ejection fraction, type 2 diabetes status, or chronicity of HF (de novo and worsening chronic HF). Randomized participants receive blinded treatment for 2 months. The primary efficacy endpoint is time to first occurrence of cardiovascular death or worsening HF (worsening HF during the index admission, rehospitalization for worsening HF, or urgent HF visit). Key safety endpoints include symptomatic hypotension and worsening kidney function. This is the first cardiovascular outcomes trial designed specifically to evaluate the efficacy and safety of in-hospital initiation of dapagliflozin in patients hospitalized for the management of acute HF. (Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure - Thrombolysis in Myocardial Infarction 68 [DAPA ACT HF-TIMI 68]; NCT04363697; EudraCT # 2022-001262-35).
650    _2
$a senioři $7 D000368
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a akutní nemoc $7 D000208
650    12
$a benzhydrylové sloučeniny $x terapeutické užití $x aplikace a dávkování $7 D001559
650    _2
$a diabetes mellitus 2. typu $x komplikace $x farmakoterapie $7 D003924
650    _2
$a dvojitá slepá metoda $7 D004311
650    12
$a glukosidy $x terapeutické užití $x aplikace a dávkování $7 D005960
650    12
$a srdeční selhání $x farmakoterapie $x patofyziologie $7 D006333
650    _2
$a hospitalizace $7 D006760
650    _2
$a randomizované kontrolované studie jako téma $7 D016032
650    12
$a glifloziny $x terapeutické užití $7 D000077203
650    _2
$a tepový objem $7 D013318
650    _2
$a výsledek terapie $7 D016896
650    _2
$a multicentrické studie jako téma $7 D015337
655    _2
$a protokol klinické studie $7 D000078325
655    _2
$a časopisecké články $7 D016428
700    1_
$a Patel, Siddharth M $u TIMI Study Group, Brigham and Women's Hospital, Boston, Massachusetts, USA; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
700    1_
$a Haller, Paul M $u TIMI Study Group, Brigham and Women's Hospital, Boston, Massachusetts, USA; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA; Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
700    1_
$a Bělohlávek, Jan $u Second Department of Internal Medicine, Cardiovascular Medicine, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic; Institute for Heart Diseases, Wroclaw Medical University, Wrocław, Poland
700    1_
$a Desai, Akshay S $u Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
700    1_
$a Drożdż, Jarosław $u Department of Cardiology, Medical University of Lodz, Lodz, Poland
700    1_
$a Inzucchi, Silvio E $u Section of Endocrinology, Yale University School of Medicine, New Haven, Connecticut, USA
700    1_
$a McMurray, John J V $u British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland, United Kingdom
700    1_
$a Merkely, Béla $u Heart and Vascular Center, Semmelweis University, Budapest, Hungary
700    1_
$a O'Meara, Eileen $u Department of Cardiology, Montreal Heart Institute, Université de Montréal, Montreal, Canada
700    1_
$a Verma, Subodh $u Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Unity Health Toronto, University of Toronto, Toronto, Ontario, Canada
700    1_
$a Cange, Abby L $u TIMI Study Group, Brigham and Women's Hospital, Boston, Massachusetts, USA; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
700    1_
$a Murphy, Sabina A $u TIMI Study Group, Brigham and Women's Hospital, Boston, Massachusetts, USA; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
700    1_
$a Sabatine, Marc S $u TIMI Study Group, Brigham and Women's Hospital, Boston, Massachusetts, USA; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
700    1_
$a Wiviott, Stephen D $u TIMI Study Group, Brigham and Women's Hospital, Boston, Massachusetts, USA; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
773    0_
$w MED00184931 $t JACC. Heart failure $x 2213-1787 $g Roč. 13, č. 5 (2025), s. 829-839
856    41
$u https://pubmed.ncbi.nlm.nih.gov/40335233 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y - $z 0
990    __
$a 20250708 $b ABA008
991    __
$a 20250731091240 $b ABA008
999    __
$a ok $b bmc $g 2366571 $s 1252956
BAS    __
$a 3
BAS    __
$a PreBMC-MEDLINE
BMC    __
$a 2025 $b 13 $c 5 $d 829-839 $e - $i 2213-1787 $m JACC. Heart failure $n JACC Heart Fail $x MED00184931
LZP    __
$a Pubmed-20250708
Back

Find record

Citation metrics

Archiving options