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SEMI trial is a single-center, real-world based prospective cohort study. The study enrolled acute heart failure patients admitting to the hospital and intended to accept heart failure therapy. The current guideline recommend ACEI/ARB/ARNI, β blocker, SGLT2i and MRA as the cornerstone medication of HFrEF therapy, but a part patients were intolerable to GDMT because of hypotension, hyperkalemia or renal insufficency. Vericiguat is a new medication therapy choice for the patients with heart failure with reduced ejection fraction (HFrEF), it may has less influence on blood pressure, it is unkonwn about the efficacy and safety of vericiguat in patients who were intolerable to GDMT.
The study aim to provide evidence of medication strategy in heart failure patients, especially for patients who are intolerable for GDMT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Failure Patients who were tolerable to GDMT | Guideline-Directed Medication Treatment contains ACEI/ARB/ARNI, β blocker, SGLT2i and MRA. The patients in this group were tolerable to all the medications and accepted GDMT. |
| |
| Heart Failure Patients who were intolerable to GDMT | The patients in this group were intolerable to one or more medication in GDMT due to hypotension, hyperkalemia or renal insufficiency. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guideline-Directed Medication Treatment (GDMT) | Other | GDMT contains ACEIs/ARBs/ARNI, β blockers, SGLT2is, MRAs. ACEI/ARB/ARNI and β blocker will gradually be titrated up to the maximum tolerable dose |
| Measure | Description | Time Frame |
|---|---|---|
| Worsening heart failure events in 180 days | Risk of death, readmission due to heart failure or accepting intravenous diuretic therapy in 180 days | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in N-terminal pro-B type natriuretic peptide | Change in NT-proBNP level from baseline to 180 days or endpoint | 180 days |
| Change in left ventricular ejection fraction (LVEF) | Change in LVEF measured by echocardiogram from baseline to 180 days or endpoint |
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Inclusion Criteria:
Exclusion Criteria:
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The patients enrolled in the study were recruited from a single center. The patients were admitted to hospital and diagnosed with acute heart failure.
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| Name | Affiliation | Role |
|---|---|---|
| Dongying Zhang, Ph.D | First Affiliated Hospital of Chongqing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated Hospital of Chongqing Medical University | Chongqing | 400042 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32222134 | Background | Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J, Lam CSP, Ponikowski P, Voors AA, Jia G, McNulty SE, Patel MJ, Roessig L, Koglin J, O'Connor CM; VICTORIA Study Group. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2020 May 14;382(20):1883-1893. doi: 10.1056/NEJMoa1915928. Epub 2020 Mar 28. | |
| 29032136 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 180 days |
| Change in left ventricular end-diastolic diameter (LVEDD) | Change in LVEDD measured by echocardiogram from baseline to 180 days or endpoint | 180 days |
| Change in left ventricular end-systolic diameter (LVESD) | Change in LVESD measured by echocardiogram from baseline to 180 days or endpoint | 180 days |
| Change in left ventricular fractional shortening (LVFS) | Change in LVFS measured by echocardiogram from baseline to 180 days or endpoint | 180 days |
| Change in blood pressure | Systolic and diastolic blood pressures were measured at admission, discharge, and up-titration to the maximum tolerated dosage | 180 days |
| Change in blood potassium | Blood potassium were measured in baseline and endpoint | 180 days |
| Armstrong PW, Roessig L, Patel MJ, Anstrom KJ, Butler J, Voors AA, Lam CSP, Ponikowski P, Temple T, Pieske B, Ezekowitz J, Hernandez AF, Koglin J, O'Connor CM. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of the Oral Soluble Guanylate Cyclase Stimulator: The VICTORIA Trial. JACC Heart Fail. 2018 Feb;6(2):96-104. doi: 10.1016/j.jchf.2017.08.013. Epub 2017 Oct 11. |
| 35363499 | Background | Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1. |
| 34447992 | Background | McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available. |
| 36356631 | Background | Mebazaa A, Davison B, Chioncel O, Cohen-Solal A, Diaz R, Filippatos G, Metra M, Ponikowski P, Sliwa K, Voors AA, Edwards C, Novosadova M, Takagi K, Damasceno A, Saidu H, Gayat E, Pang PS, Celutkiene J, Cotter G. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022 Dec 3;400(10367):1938-1952. doi: 10.1016/S0140-6736(22)02076-1. Epub 2022 Nov 7. |
| 41848038 | Derived | Chen J, Liu J, Xiao R, Wang Y, Gao L, Zhao W, Li Z, He S, Zhang Y, Wen X, Zhang D. Efficacy of Vericiguat in Acute Heart Failure: A Target Trial Emulation Study. J Am Heart Assoc. 2026 Apr 7;15(7):e046168. doi: 10.1161/JAHA.125.046168. Epub 2026 Mar 18. |