{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,25]],"date-time":"2026-02-25T18:36:59Z","timestamp":1772044619347,"version":"3.50.1"},"reference-count":35,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"5","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Heart Failure"],"published-print":{"date-parts":[[2019,5]]},"abstract":"<jats:sec>\n            <jats:title>Background<\/jats:title>\n            <jats:p>The VITALITY-HFpEF trial (Evaluate the Efficacy and Safety of the Oral sGC Stimulator Vericiguat to Improve Physical Functioning in Daily Living Activities of Patients With Heart Failure and Preserved Ejection Fraction) is designed to determine the efficacy and safety of a novel oral soluble guanylate cyclase stimulator, vericiguat, on quality of life and exercise tolerance in heart failure patients with preserved ejection fraction (HFpEF). Impaired physical functioning reduces the quality of life in patients with HFpEF. The primary goal of HF treatment along with improving survival is to improve function, reduce symptoms, and maximize quality of life. Abnormal cyclic guanosine monophosphate signaling may contribute to physical limitations in patients with HFpEF via central and peripheral mechanisms. Exploratory post hoc analyses from a prior trial showed that vericiguat can improve patient-relevant domains of the Kansas City Cardiomyopathy Questionnaire, especially the physical limitation score.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods and Results<\/jats:title>\n            <jats:p>VITALITY-HFpEF is a placebo-controlled, double-blind, multi-center, phase IIb trial of \u2248735 patients, \u226545 years with HFpEF and ejection fraction \u226545% who will be randomized 1:1:1 to placebo, 10 mg, or 15 mg vericiguat. The primary end point is change in Kansas City Cardiomyopathy Questionnaire physical limitation score from baseline to week 24 and change in 6-minute walk test from baseline to week 24 is the secondary end point.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>VITALITY-HFpEF is the first trial designed to assess the efficacy of vericiguat in patients with HFpEF using the Kansas City Cardiomyopathy Questionnaire physical limitation score as a novel primary end point. This study will also extend the prior dosing experience with vericiguat in HF by studying the safety and efficacy of a 15 mg dose.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Clinical Trial Registration<\/jats:title>\n            <jats:p>\n              URL:\n              <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n              . Unique identifier: NCT03547583.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circheartfailure.119.005998","type":"journal-article","created":{"date-parts":[[2019,5,17]],"date-time":"2019-05-17T09:02:04Z","timestamp":1558083724000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":43,"title":["Rationale and Design of the VITALITY-HFpEF Trial"],"prefix":"10.1161","volume":"12","author":[{"given":"Javed","family":"Butler","sequence":"first","affiliation":[{"name":"Department of Medicine, University of Mississippi Medical Center, Jackson (J.B.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carolyn S.P.","family":"Lam","sequence":"additional","affiliation":[{"name":"National Heart Centre Singapore, Duke-National University of Singapore (C.S.P.L.)."},{"name":"The George Institute for Global Health (C.S.P.L.)."},{"name":"University Medical Center Groningen, (C.S.P.L.), the Netherlands."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin J.","family":"Anstrom","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Durham, NC (K.J.A., A.F.H.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Justin","family":"Ezekowitz","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (J.E., P.W.A.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adrian F.","family":"Hernandez","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Durham, NC (K.J.A., A.F.H.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher M.","family":"O\u2019Connor","sequence":"additional","affiliation":[{"name":"Duke University Medical Center, Durham, NC (C.M.O.)."},{"name":"Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Burkert","family":"Pieske","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Cardiology, Charit\u00e9 Universit\u00e4tsmedizin Berlin, Campus Virchow Klinikum, Germany (B.P.)."},{"name":"Department of Internal Medicine and Cardiology, German Heart Center Berlin, and German Centre for Cardiovascular Research (DZHK), Partner site Berlin, and Berlin Institute of Health (BIH), Germany (B.P.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Piotr","family":"Ponikowski","sequence":"additional","affiliation":[{"name":"Department of Heart Diseases, Wroclaw Medical University, Poland (P.P.)."},{"name":"Cardiology Department, Military Hospital, Wroc\u0142aw, Poland (P.P.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanjiv J.","family":"Shah","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (S.J.S.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Scott D.","family":"Solomon","sequence":"additional","affiliation":[{"name":"Cardiovascular Division, Department of Medicine, Brigham and Women\u2019s Hospital, Boston, MA (S.D.S.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adriaan A.","family":"Voors","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University of Groningen (A.A.V.), the Netherlands."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yi","family":"Wu","sequence":"additional","affiliation":[{"name":"Bayer AG, Wuppertal, Germany (Y.W., F.C., L.B., L.R.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francine","family":"Carvalho","sequence":"additional","affiliation":[{"name":"Bayer AG, Wuppertal, Germany (Y.W., F.C., L.B., L.R.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luke","family":"Bamber","sequence":"additional","affiliation":[{"name":"Bayer AG, Wuppertal, Germany (Y.W., F.C., L.B., L.R.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert O.","family":"Blaustein","sequence":"additional","affiliation":[{"name":"Cardiovascular Clinical Research, Merck &amp; 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