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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1257-5069 | Other Identifier | World Health Organization (WHO) | |
| 2020-004170-22 | EudraCT Number |
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This study will look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight.
This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms.
Participants will either get semaglutide or "dummy" medicine, which treatment participants get is decided by chance.
Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm.
During the study participants will have talks with the study staff about healthy lifestyle and physical activity.
The study will last for about 59 weeks, that is a little more than 1 year. Participants will have 12 clinic visits with the study doctor.
Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide 2.4 mg once weekly (OW) | Experimental | Participants will receive semaglutide injections for 52 weeks. |
|
| Semaglutide placebo OW | Placebo Comparator | Participants will receive semaglutide placebo injections for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly for 52 weeks. Dose will be gradually increased to 2.4 mg: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 52. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score | Score on a scale of 0 to 100 where the score 100 means the least burden for the participant. | From baseline (week 0) to end of treatment (week 52) |
| Change in body weight | Percentage (%) | From baseline (week 0) to end of treatment (week 52) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-minute walking distance | Measured in metres | From baseline (week 0) to end of treatment (week 52) |
| Hierarchical composite of time to all-cause death | Measured as total wins for each treatment group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (Dept.1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Shore Rsrch Inst, LLC | Fairhope | Alabama | 36532 | United States | ||
| Mobile Heart Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37294245 | Background | Kosiborod MN, Abildstrom SZ, Borlaug BA, Butler J, Christensen L, Davies M, Hovingh KG, Kitzman DW, Lindegaard ML, Moller DV, Shah SJ, Treppendahl MB, Verma S, Petrie MC. Design and Baseline Characteristics of STEP-HFpEF Program Evaluating Semaglutide in Patients With Obesity HFpEF Phenotype. JACC Heart Fail. 2023 Aug;11(8 Pt 1):1000-1010. doi: 10.1016/j.jchf.2023.05.010. Epub 2023 May 21. | |
| 41045908 |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
|
| Placebo (Semaglutide) | Drug | Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly for 52 weeks. |
|
| From baseline (week 0) to end of study (week 57) |
| Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit | Measured as total wins for each treatment group | From baseline (week 0) to end of study (week 57) |
| Hierarchical composite of time to first heart failure event requiring hospitalisation or urgent heart failure visit | Measured as total wins for each treatment group. | From baseline (week 0) to end of study (week 57) |
| Hierarchical composite of difference at least 15 inKansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score change from baseline to 52 weeks | Measured as total wins for each treatment group. | From baseline (week 0) to end of study (week 57) |
| Hierarchical composite of difference at least 10 in KCCQ clinical summary score change from baseline to 52 weeks | Measured as total wins for each treatment group. | From baseline (week 0) to end of study (week 57) |
| Hierarchical composite of difference at least 5 in KCCQ clinical summary score change from baseline to 52 weeks | Measured as total wins for each treatment group. | From baseline (week 0) to end of study (week 57) |
| Hierarchical composite of difference at least 30 metres in six-minute walking distance change from baseline to 52 weeks (assessed by the win ratio) | Measured as total wins for each treatment group. | From baseline (week 0) to end of study (week 57) |
| Change in C-Reactive Protein | Presented as ratio to baseline | From baseline (week -2) to end of treatment (week 52) |
| Participant achieving 10% weight loss or more (Yes/No) | Count of participants | From baseline (week 0) to end of treatment (week 52) |
| Participant achieving 15% weight loss or more (Yes/No) | Count of participants | From baseline (week 0) to end of treatment (week 52) |
| Participant achieving 20% weight loss or more (Yes/No) | Count of participants | From baseline (week 0) to end of treatment (week 52) |
| Participant improving 5 points or more in KCCQ clinical summary score | Count of participants | From baseline (week 0) to end of treatment (week 52) |
| Participant improving 10 points or more in KCCQ clinical summary score (Yes/No) | Count of participants | From baseline (week 0) to end of treatment (week 52) |
| Change in KCCQ overall summary score | Score on a scale of 0 to 100 where the score 100 means the least burden for the participant. | From baseline (week 0) to end of treatment (week 52) |
| Participant achieving threshold for clinically meaningful within-subject change in KCCQ-CSS | Count of participants | From baseline (week 0) to end of treatment (week 52) |
| Participant achieving threshold for clinically meaningful within-subject change in 6MWD | Count of participants | From baseline (week 0) to end of treatment (week 52) |
| Change in waist circumference | Measured in centimetre (cm) | From baseline (week 0) to end of treatment (visit 52) |
| Change in systolic blood pressure | Measured in millimetre of mercury (mmHg) | From baseline (week -2) to end of treatment (week 52) |
| Change in glycated haemoglobin (HbA1c) | Measured in percentage (%)-point | From baseline (week 0) to end of treatment (week 52) |
| Number of treatment emergent severe or clinically significant hypoglycaemia episodes | Count of events | From baseline (week 0) to end of trial (week 57) |
| Mobile |
| Alabama |
| 36608 |
| United States |
| National Heart Institute Cal | Beverly Hills | California | 90211 | United States |
| John Muir Physicians Network | Concord | California | 94520 | United States |
| Valley Clinical Trials | Covina | California | 91723 | United States |
| Keck Medical Center of USC - Outpatient Clinic | Los Angeles | California | 90033 | United States |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | United States |
| Lundquist Inst-Biomed Innovtn | Torrance | California | 90502 | United States |
| New West Physicians,Inc. | Golden | Colorado | 80401 | United States |
| Excel Med Ctr Clinical Trials | Boca Raton | Florida | 33434 | United States |
| Bay Area Cardiology Associates, P.A. | Brandon | Florida | 33511 | United States |
| Baptist Heart Specialists_Jacksonville | Jacksonville | Florida | 32258 | United States |
| CV Res Ctr of S Florida | Miami | Florida | 33173 | United States |
| Endeavor Health Clinical Operations-NCH | Arlington Heights | Illinois | 60005 | United States |
| Endeavor Health Glenbook Hosp | Evanston | Illinois | 60201 | United States |
| Northwestern University_Chicago_0 | Evanston | Illinois | 60208 | United States |
| Chicago Medical Research LLC | Hazel Crest | Illinois | 60429 | United States |
| Deaconess Specialty Physicians | Evansville | Indiana | 47747 | United States |
| Ascension St. Vincent Medical Group | Indianapolis | Indiana | 46260 | United States |
| Cardiovascular Rsrch of NW_IN | Munster | Indiana | 46321 | United States |
| Cotton-O'Neil Heart Center | Topeka | Kansas | 66606 | United States |
| Baptist Health Woodland | Elizabethtown | Kentucky | 42701 | United States |
| The Research Group of Lexington LLC | Lexington | Kentucky | 40503 | United States |
| Baptist Health Louisville | Louisville | Kentucky | 40207 | United States |
| Grace Research, LLC | Bossier City | Louisiana | 71111 | United States |
| Heart Clinic of Hammond | Hammond | Louisiana | 70403 | United States |
| Clinical Trials of Ame, LLC | Monroe | Louisiana | 71201 | United States |
| Grace Research, LLC_Shreveport | Shreveport | Louisiana | 71105 | United States |
| Louisiana Heart Center_Slidell | Slidell | Louisiana | 70458 | United States |
| Ascension Saint Agnes Heart Ca | Baltimore | Maryland | 21229 | United States |
| MedStar Good Samaritan Hosp | Baltimore | Maryland | 21239 | United States |
| John Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Elite Research Center | Flint | Michigan | 48532 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Univ of Mississippi Med Ctr | Jackson | Mississippi | 39216 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| St Louis Heart & Vascular, P.C. | St Louis | Missouri | 63136 | United States |
| Bryan Heart | Lincoln | Nebraska | 68506 | United States |
| CHI Health Clinic Cardiology (CUMC - Bergan Mercy) | Omaha | Nebraska | 68124 | United States |
| St Francis Hospital Lindner Research Center | Greenvale | New York | 11548 | United States |
| NY Presbyt Hosp-W Cornell Med | New York | New York | 10021 | United States |
| Carteret Medical Group | Morehead City | North Carolina | 28557 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| Lindner Center,Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Hospital of University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Sanford Health_Sioux Falls | Sioux Falls | South Dakota | 57117 | United States |
| Tennessee Center for Clinical Trials | Tullahoma | Tennessee | 37388 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Angio Cardiac Care of Texas | Houston | Texas | 77025 | United States |
| Cardiology Consultants of Danville Inc. | Danville | Virginia | 24541 | United States |
| Virginia Heart | Falls Church | Virginia | 22042 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298-5058 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| CEMEDIC | CABA | Buenos Aires | C1440CFD | Argentina |
| Centro de Investigación y Prevención Cardiovascular | CABA | C1061AAS. | Argentina |
| Centro de Investigación y Prevención Cardiovascular | CABA | C1119ACN | Argentina |
| CEMEDIC | CABA | C1440CFD | Argentina |
| Cardiología Palermo Duplicate | Ciudad Autónoma de Buenos Aire | 1425 | Argentina |
| Cardiología Palermo | Ciudad Autónoma de Buenos Aire | 1425 | Argentina |
| Instituto de Cardiología de Corrientes | Corrientes | W3400AMZ | Argentina |
| Consultorio Integral de Atención al Diabético | Morón | B1708IFF | Argentina |
| Sanatorio Britanico S.A. | Rosario, Santa Fe | S2000CVB | Argentina |
| Krankenhaus St. Josef Braunau | Braunau am Inn | 5280 | Austria |
| Medizinische Universität Graz | Graz | 8036 | Austria |
| Medizinische Universität Graz | Graz | A 8036 | Austria |
| Fließer-Görzer [Ordination] | Saint Stefan | 8511 | Austria |
| Medizinische Universität Wien | Vienna | 1090 | Austria |
| Klinik Favoriten | Vienna | 1100 | Austria |
| Imed 19- privat | Vienna | 1190 | Austria |
| AKH Universitätsklinik für Innere Medizin II | Vienna | A 1090 | Austria |
| Universitätsklinik für Innere Medizin II | Vienna | A 1090 | Austria |
| University of Calgary_Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| Univ of Alberta Hosp Edmonton | Edmonton | Alberta | T6G 2B7 | Canada |
| North Shore Heart Centre | North Vancouver | British Columbia | V7M 2H4 | Canada |
| SMH Cardiology Clinical Trials Inc. | Surrey | British Columbia | V3V 0C6 | Canada |
| St. Boniface Hospital | Winnipeg | Manitoba | R2H 2HA6 | Canada |
| Cambridge Cardiac Care Centre | Cambridge | Ontario | N1R 6V6 | Canada |
| Partnrs Adv Cardio Eval (PACE) | Newmarket | Ontario | L3Y 2P6 | Canada |
| Oakville Cardiovascular Research LP | Oakville | Ontario | L6K 3W7 | Canada |
| Heart Health Institute Research, Inc. | Scarborough Village | Ontario | M1B 4Z8 | Canada |
| Dr. Louis Yao | Weston | Ontario | M9N 1W4 | Canada |
| ViaCar Recherche Clinique Inc | Brossard | Quebec | J4Z 2K9 | Canada |
| Applied Med Inf Res | Montreal | Quebec | H4A 3T2 | Canada |
| Ctr de Med Metab de Lanaudiere | Terrebonne | Quebec | J6X 4P7 | Canada |
| Institut universitaire de cardiologie | Québec | G1V 4G5 | Canada |
| Edumed Broumov | Broumov | 550 01 | Czechia |
| Fakultní poliklinika VFN ambulance Srdecniho selhani | Prague | 120 00 | Czechia |
| IKEM | Prague | 140 21 | Czechia |
| MEDICON a.s. | Prague | 170 00 | Czechia |
| Poliklinika Holešovice VISIONARY - Medicon Pharm s.r.o. | Prague | 170 00 | Czechia |
| Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU) | Berlin | 13353 | Germany |
| Cardiologicum Dresden und Pirna - MVZ "Am Felsenkeller" (Dresden) | Dresden | 01277 | Germany |
| Zentrum fuer klinische Studien Suedbrandenburg GmbH | Elsterwerda | 04910 | Germany |
| MVZ CCB Frankfurt und Main-Taunus GbR | Frankfurt | 60389 | Germany |
| Medical Center - University Of Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Universitätsklinikum Freiburg - Medical Center | Freiburg im Breisgau | 79106 | Germany |
| B. Braun Ambulantes Herzzentrum Kassel MVZ GmbH | Kassel | 34121 | Germany |
| Universitätsklinikum Leipzig - Klinik und Poliklinik für Kardiologie | Leipzig | 04103 | Germany |
| Universitätsmedizin Mainz, Kardiologie I, Studienzentrum | Mainz | 55131 | Germany |
| Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz | Würzburg | 97078 | Germany |
| Lausmed Kft. | Baja | Bács-Kiskun county | 6500 | Hungary |
| Selye János Kórház | Komárom | Komárom-Esztergom | 2921 | Hungary |
| Szent Margit Rendelőintézet Nonprofit Kft. | Budapest | 1032 | Hungary |
| Semmelweis Egyetem Szent Rókus Klinikai Tömb | Budapest | 1085 | Hungary |
| Gottsegen György Országos Kardiológiai Intézet | Budapest | 1096 | Hungary |
| Semmelweis Egyetem Városmajori Szív- és Érgyógyászat | Budapest | 1122 | Hungary |
| Jahn Ferenc Dél-pesti Kórház és Rendelőintézet | Budapest | 1204 | Hungary |
| DE KK Kardiológiai és Szívsebészeti klinika | Debrecen | 4032 | Hungary |
| Borsod-Abaúj-Zemplén Megyei Központi Kórház | Miskolc | 3526 | Hungary |
| Zala Megyei Szent Rafael Kórház | Zalaegerszeg | 8900 | Hungary |
| Krishna Institute of medical sciences Ltd | Secunderabad | A.P. | 500 003 | India |
| CIMS- Care Institute of Medical Sciences | Ahmedabad | Gujarat | 380060 | India |
| Rhythm Heart Institute | Vadodara | Gujarat | 390022 | India |
| K R Hospital | Mysore | Karnataka | 570001 | India |
| Lisie Hospital | Kochi | Kerala | 682018 | India |
| Vijan Cardiac & Critical Care | Nashik | Maharashtra | 422005 | India |
| Vijan Hospital & Research Centre | Nashik | Maharashtra | 422005 | India |
| G B Pant Institute of Postgraduate Medical Education and Research | New Delhi | National Capital Territory of Delhi | 110002 | India |
| Max Super Speciality Hospital, Saket | New Delhi | National Capital Territory of Delhi | 110017 | India |
| Batra Hospital and Medical Research Center | New Delhi | National Capital Territory of Delhi | 110062 | India |
| VMMC & Safdarjung Hospital | New Dehli | New Delhi | 110029 | India |
| SP Medical College & A.G.Hospital Bikaner | Bikaner | Rajasthan | 334003 | India |
| SP Medical College | Bikaner | Rajasthan | 334003 | India |
| Apollo Hospitals Education & Research Foundation | Chennai | Tamil Nadu | 600006 | India |
| Gandhi Memorial Hospital- King George's Medical University | Lucknow | Uttar Pradesh | 226003 | India |
| G B Pant Institute of Postgraduate Medical Education and Res | New Delhi | 110002 | India |
| Dr. BL Kapur Memorial Hospital | New Delhi | 110005 | India |
| Max Super Speciality Hospital_New Delhi | New Delhi | 110017 | India |
| Sir Ganga Ram Hospital | New Delhi | 110060 | India |
| Hadassah Ein Karam MC - Cardio Department | Jerusalem | 91120 | Israel |
| Western Galilee MC - Cardiology Department | Nahariya | 22100 | Israel |
| Rabin MC Beilinson - Heart Failure Unit | Petah Tikva | 49100 | Israel |
| Sourasky MC - Cardio Vascular Research Center | Tel Aviv | 6423906 | Israel |
| Sheba MC - Cardiology Clinical Research Unit | Tel Litwinsky | 5265601 | Israel |
| Spedali Civili Brescia | Brescia | Bs | 25123 | Italy |
| A.O.U. Ferrara, Sant'Anna | Cona (Ferrara) | Fe | 44124 | Italy |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII | Bergamo | Lombardy | 24127 | Italy |
| Centro Cardiologico Monzino | Milan | 20138 | Italy |
| Azienda Ospedaliera di Padova - MASTER | Padova | 35128 | Italy |
| A.O.U. Policlinico Umberto I | Roma | 00161 | Italy |
| Policlinico A. Gemelli IRCCS | Rome | 00168 | Italy |
| Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology | Himeji-shi, Hyogo | 670-8560 | Japan |
| Kokura Memorial Hospital_Cardiology | Kitakyushu-shi,Fukuoka | 802-8555 | Japan |
| Okayama University Hospital_Cardiovascular Medicine | Okayama-shi, Okayama | 700-8558 | Japan |
| Omihachiman Community Medical Center_Omihachiman-shi, Siga | Omihachiman-shi, Siga | 523-0082 | Japan |
| Osaka City General Hospital_Endocrinology and Diabetes Mellitus | Osaka | 534-0021 | Japan |
| Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine | Osaka-shi, Osaka | 530-8480 | Japan |
| Hanaoka Seishu Memorial Hosp._Cardiovascular Medicine | Sapporo-shi, Hokkaido | 062-0003 | Japan |
| Tokyo Shinagawa Hospital_Cardiovascular Medicine | Tokyo | 140-8522 | Japan |
| Gelre Ziekenhuizen Apeldoorn | Apeldoorn | 7334 DZ | Netherlands |
| Rijnstate Ziekenhuis | Arnhem | 6815 AD | Netherlands |
| Rode Kruis Ziekenhuis Beverwijk | Beverwijk | 1942 LE | Netherlands |
| UMC Groningen | Groningen | 9713 GZ | Netherlands |
| Saxenburgh Medisch Centrum | Hardenberg | 7772 SE | Netherlands |
| Frisius MC Leeuwarden | Leeuwarden | 8934 AD | Netherlands |
| Bravis Ziekenhuis | Roosendaal | 4708 AE | Netherlands |
| Malopolskie Centrum Sercowo-Naczyniowe | Chrzanów | Lesser Poland Voivodeship | 32-500 | Poland |
| Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio | Bialystok | Podlaskie Voivodeship | 15-276 | Poland |
| Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio | Bialystok | Podlaskie Voivodeship | 15-540 | Poland |
| Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman | Gdynia | Pomeranian Voivodeship | 81-157 | Poland |
| Pro Familia Altera Sp. z o.o. | Katowice | Silesian Voivodeship | 40-648 | Poland |
| I Katedra i Klinika Kardiologii WUM SPCSK | Warsaw | 02-097 | Poland |
| Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Łodzi | Lodz | Łódź Voivodeship | 90-549 | Poland |
| Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | 15706 | Spain |
| Clínica Nuevas Tecnologías en Diabetes y Endocrinología | Seville | 41003 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Dept of Med Sahlgrenska/Östra | Gothenburg | 416 50 | Sweden |
| Medicinkliniken Ryhov | Jönköping | 551 85 | Sweden |
| Hjärtmottagningen | Uppsala | 751 85 | Sweden |
| Ninewells Hospital | Dundee | DD1 9SY | United Kingdom |
| Glasgow Clinical Research Facility | Glasgow | G31 2ER | United Kingdom |
| Glasgow Royal Infirmary | Glasgow | G31 2ER | United Kingdom |
| Queen Elizabeth University Hospital | Glasgow | G51 4TF | United Kingdom |
| Wycombe General Hospital | High Wycombe | HP11 2TT | United Kingdom |
| Aintree University Hospital | Liverpool | L9 7AL | United Kingdom |
| University Hospital Aintree | Liverpool | L9 7AL | United Kingdom |
| Manchester Royal Infirmary_Manchester_0 | Manchester | M13 9WL | United Kingdom |
| Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| Great Western Hospital | Swindon | SN3 6BB | United Kingdom |
| Derived |
| Borlaug BA, Kitzman DW, Patel S, Chinnakondepalli KM, Butler J, Davies MJ, Petrie MC, Shah SJ, Verma S, Nunez J, Einfeldt MN, Liisberg K, Salsali A, Kosiborod MN; STEP-HFpEF Trial Committees and Investigators. Semaglutide and Exercise Function in Obesity-Related HFpEF: Insights From the STEP-HFpEF Program. JACC Heart Fail. 2025 Nov;13(11):102660. doi: 10.1016/j.jchf.2025.102660. Epub 2025 Oct 3. |
| 40956259 | Derived | Pandey A, Kitzman DW, Chinnakondepalli KM, Patel S, Borlaug BA, Butler J, Davies MJ, Shah SJ, Verma S, Ronnback C, Domdey A, Liisberg K, Schou M, Perna E, Ahmed FZ, Fu M, Petrie MC, Kosiborod MN. Frailty and Effects of Semaglutide in Obesity-Related HFpEF: Findings From the STEP-HFpEF Program. JACC Heart Fail. 2025 Oct;13(10):102610. doi: 10.1016/j.jchf.2025.102610. Epub 2025 Sep 15. |
| 39848268 | Derived | Davies MJ, van der Meer P, Verma S, Patel S, Chinnakondepalli KM, Borlaug BA, Butler J, Kitzman DW, Shah SJ, Harring S, Salsali A, Rasmussen S, von Lewinski D, Abhayaratna W, Petrie MC, Kosiborod MN; STEP-HFpEF Trials Committees and Investigators. Semaglutide in obesity-related heart failure with preserved ejection fraction and type 2 diabetes across baseline HbA1c levels (STEP-HFpEF DM): a prespecified analysis of heart failure and metabolic outcomes from a randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2025 Mar;13(3):196-209. doi: 10.1016/S2213-8587(24)00304-8. Epub 2025 Jan 20. |
| 39222642 | Derived | Kosiborod MN, Deanfield J, Pratley R, Borlaug BA, Butler J, Davies MJ, Emerson SS, Kahn SE, Kitzman DW, Lingvay I, Mahaffey KW, Petrie MC, Plutzky J, Rasmussen S, Ronnback C, Shah SJ, Verma S, Weeke PE, Lincoff AM; SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM Trial Committees and Investigators. Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials. Lancet. 2024 Sep 7;404(10456):949-961. doi: 10.1016/S0140-6736(24)01643-X. Epub 2024 Aug 30. |
| 39217567 | Derived | Solomon SD, Ostrominski JW, Wang X, Shah SJ, Borlaug BA, Butler J, Davies MJ, Kitzman DW, Verma S, Abildstrom SZ, Nygaard Einfeldt M, Rasmussen S, Abhayaratna WP, Ahmed FZ, Ben-Gal T, Chopra V, Ito H, Merkely B, Nunez J, Senni M, van der Meer P, Wolf D, Petrie MC, Kosiborod MN; STEP-HFpEF Trial Committees and Investigators. Effect of Semaglutide on Cardiac Structure and Function in Patients With Obesity-Related Heart Failure. J Am Coll Cardiol. 2024 Oct 22;84(17):1587-1602. doi: 10.1016/j.jacc.2024.08.021. Epub 2024 Aug 30. |
| 39217565 | Derived | Verma S, Butler J, Borlaug BA, Davies MJ, Kitzman DW, Petrie MC, Shah SJ, Jensen TJ, Rasmussen S, Ronnback C, Merkely B, O'Keefe E, Kosiborod MN; STEP-HFpEF and STEP-HFpEF DM Investigators. Atrial Fibrillation and Semaglutide Effects in Obesity-Related Heart Failure With Preserved Ejection Fraction: STEP-HFpEF Program. J Am Coll Cardiol. 2024 Oct 22;84(17):1603-1614. doi: 10.1016/j.jacc.2024.08.023. Epub 2024 Aug 30. |
| 39217564 | Derived | Verma S, Petrie MC, Borlaug BA, Butler J, Davies MJ, Kitzman DW, Shah SJ, Ronnback C, Abildstrom SZ, Liisberg K, Wolf D, von Lewinski D, Lelonek M, Melenovsky V, Senni M, Kosiborod MN; STEP-HFpEF Trial Committees and Investigators. Inflammation in Obesity-Related HFpEF: The STEP-HFpEF Program. J Am Coll Cardiol. 2024 Oct 22;84(17):1646-1662. doi: 10.1016/j.jacc.2024.08.028. Epub 2024 Aug 30. |
| 38913004 | Derived | Schou M, Petrie MC, Borlaug BA, Butler J, Davies MJ, Kitzman DW, Shah SJ, Verma S, Patel S, Chinnakondepalli KM, Harring S, Abildstrom SZ, Liisberg K, Kosiborod MN; STEP-HFpEF Trial Committees and Investigators. Semaglutide and NYHA Functional Class in Obesity-Related Heart Failure With Preserved Ejection Fraction: The STEP-HFpEF Program. J Am Coll Cardiol. 2024 Jul 16;84(3):247-257. doi: 10.1016/j.jacc.2024.04.038. Epub 2024 Jun 23. |
| 38913003 | Derived | Verma S, Butler J, Borlaug BA, Davies M, Kitzman DW, Shah SJ, Petrie MC, Barros E, Ronnback C, Vestergaard LS, Schou M, Ezekowitz JA, Sharma K, Patel S, Chinnakondepalli KM, Kosiborod MN; STEP-HFpEF Trial Committees and Investigators. Efficacy of Semaglutide by Sex in Obesity-Related Heart Failure With Preserved Ejection Fraction: STEP-HFpEF Trials. J Am Coll Cardiol. 2024 Aug 27;84(9):773-785. doi: 10.1016/j.jacc.2024.06.001. Epub 2024 Jun 23. |
| 38739118 | Derived | Shah SJ, Sharma K, Borlaug BA, Butler J, Davies M, Kitzman DW, Petrie MC, Verma S, Patel S, Chinnakondepalli KM, Einfeldt MN, Jensen TJ, Rasmussen S, Asleh R, Ben-Gal T, Kosiborod MN. Semaglutide and diuretic use in obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF-DM trials. Eur Heart J. 2024 Sep 14;45(35):3254-3269. doi: 10.1093/eurheartj/ehae322. |
| 38599221 | Derived | Butler J, Shah SJ, Petrie MC, Borlaug BA, Abildstrom SZ, Davies MJ, Hovingh GK, Kitzman DW, Moller DV, Verma S, Einfeldt MN, Lindegaard ML, Rasmussen S, Abhayaratna W, Ahmed FZ, Ben-Gal T, Chopra V, Ezekowitz JA, Fu M, Ito H, Lelonek M, Melenovsky V, Merkely B, Nunez J, Perna E, Schou M, Senni M, Sharma K, van der Meer P, Von Lewinski D, Wolf D, Kosiborod MN; STEP-HFpEF Trial Committees and Investigators. Semaglutide versus placebo in people with obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials. Lancet. 2024 Apr 27;403(10437):1635-1648. doi: 10.1016/S0140-6736(24)00469-0. Epub 2024 Apr 7. |
| 38587233 | Derived | Kosiborod MN, Petrie MC, Borlaug BA, Butler J, Davies MJ, Hovingh GK, Kitzman DW, Moller DV, Treppendahl MB, Verma S, Jensen TJ, Liisberg K, Lindegaard ML, Abhayaratna W, Ahmed FZ, Ben-Gal T, Chopra V, Ezekowitz JA, Fu M, Ito H, Lelonek M, Melenovsky V, Merkely B, Nunez J, Perna E, Schou M, Senni M, Sharma K, van der Meer P, Von Lewinski D, Wolf D, Shah SJ; STEP-HFpEF DM Trial Committees and Investigators. Semaglutide in Patients with Obesity-Related Heart Failure and Type 2 Diabetes. N Engl J Med. 2024 Apr 18;390(15):1394-1407. doi: 10.1056/NEJMoa2313917. Epub 2024 Apr 6. |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
Not provided
Not provided
Not provided