Heart Failure With Reduced Ejection FractionSEMINCT05799638
Strategy, Efficacy and Safety of Medication Usage in Heart Failure Patients Who Were Intolerable to GDMT
An observational study of Heart Failure With Reduced Ejection Fraction, run by Chongqing Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Guideline-Directed Medication Treatment (GDMT)
- How many people
- 263 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients enrolled in the study were recruited from a single center. The patients were admitted to hospital and diagnosed with acute heart failure.
Who may be able to join
- Sent to the Department of Cardiovascular disease of The First Affiliated Hospital of Chongqing Medical University for inpatient treatment.
- Diagnosed with acute heart failure or acute exacerbation of chronic heart failure
- Patients with typical heart failure symptoms and signs such as dyspnea, fatigue after exercise, paroxysmal nocturnal dyspnea, lower limb edema, lung auscultation rale, etc.
- Left ventricular ejection fraction measured by echocardiogram ≤ 45% and patients had elevated level of NT-proBNP (patients<55 years, NT-proBNP>450 pg/mL; patients≥55 years and <75 years, NT-proBNP>900 pg/mL; patients ≥ 75 years, NT-proBNP>1800 pg/mL)
- New York Heart Association functional class II to IV.
Who cannot join
- Left ventricular ejection fraction measured by echocardiogram > 45% or diagnosed with heart failure with preserved ejection fraction.
- Age ≤ 18 years old.
- Allergic to anti-heart failure medications including ACEI/ARB/ARNI, beta blockers, SGLT2i, oral diuretics and vericiguat.
- Diagnosed as other diseases with symptoms similar to heart failure such as acute exacerbation of chronic obstructive pulmonary disease, etc.
- Dignosed with acute coronary syndrome, including unstable angina, non ST-elevation myocardial infarction and ST-elevation myocardial infarction. Received percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to the trial start, or indication for PCI or CABG at the trial start.
- Hepatic insufficiency classified as Child-Pugh B or C.
Show all 15Show fewer
- Diagnosed with restrictive cardiomyopathy.
- Diagnosed with cardiac amyloidosis, Fabry disease or other rare cardiomyopathy.
- Diagnosed with systematic lupus erythematosus or other autoimmune disease.
- Diagnosed with or suspect diagnosed with active tumor.
- Diagnosed with idiopathic pulmonary hypertension, receiving PDE-5 inhibitor or other sGC stimulators.
- Pregnant woman.
- Combined with severe infection at admission or combined with uncontrolled tuberculosis.
- Diagnosed with severe and uncontrolled congenital heart disease.
- Patients with rheumatic valvular disease who have indications for surgery but have not undergone surgical treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated Hospital of Chongqing Medical University
Chongqing, 400042
About this study
Official title: Medication Strategies in Heart Failure Patients Who Are Intolerable to Guideline-directed Medical Therapy
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.
Read the detailed description
The study aim to provide evidence of medication strategy in heart failure patients, especially for patients who are intolerable for GDMT.
- Being tested
- Guideline-Directed Medication Treatment (GDMT)
- Keywords
- heart failure, myocardial fibrosis, vericiguat
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Guideline-Directed Medication Treatment (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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worsening heart failure events in 180 days
Risk of death, readmission due to heart failure or accepting intravenous diuretic therapy in 180 days
Measured: 180 days
Secondary outcomes (7)
Change in N-terminal pro-B type natriuretic peptide
Change in NT-proBNP level from baseline to 180 days or endpoint
Measured: 180 days
Change in left ventricular ejection fraction (LVEF)
Change in LVEF measured by echocardiogram from baseline to 180 days or endpoint
Measured: 180 days
Change in left ventricular end-diastolic diameter (LVEDD)
Change in LVEDD measured by echocardiogram from baseline to 180 days or endpoint
Measured: 180 days
Change in left ventricular end-systolic diameter (LVESD)
Change in LVESD measured by echocardiogram from baseline to 180 days or endpoint
Measured: 180 days
Change in left ventricular fractional shortening (LVFS)
Change in LVFS measured by echocardiogram from baseline to 180 days or endpoint
Measured: 180 days
Change in blood pressure
Systolic and diastolic blood pressures were measured at admission, discharge, and up-titration to the maximum tolerated dosage
Measured: 180 days
Change in blood potassium
Blood potassium were measured in baseline and endpoint
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongying Zhang, Chongqing Medical University
- Investigators
- Dongying Zhang, Ph.D, Study chair, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799638
- Sponsor's protocol ID
- SEMI-HF
- Acronym
- SEMI
- Status last verified
- Jul 2024
- First submitted
- 12 Mar 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32222134Armstrong 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.
PubMed 29032136Heidenreich 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.
PubMed 35363499McDonagh 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.
PubMed 34447992Mebazaa 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.
PubMed 36356631Chen 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.
PubMed 41848038
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Strategies in Heart Failure Patients Who Are Intolerable to Guideline-directed Medical Therapy
- ClinicalTrials.gov ID
- NCT05799638
- Acronym / sponsor ID
- SEMI / SEMI-HF
- Keywords
- heart failure, myocardial fibrosis, vericiguat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study aim to provide evidence of medication strategy in heart failure patients, especially for patients who are intolerable for GDMT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Patients who were tolerable to GDMT | – | Other: Guideline-Directed Medication Treatment (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients enrolled in the study were recruited from a single center. The patients were admitted to hospital and diagnosed with acute heart failure.
Key inclusion criteria (5 listed)
- Sent to the Department of Cardiovascular disease of The First Affiliated Hospital of Chongqing Medical University for inpatient treatment.
- Diagnosed with acute heart failure or acute exacerbation of chronic heart failure
- Patients with typical heart failure symptoms and signs such as dyspnea, fatigue after exercise, paroxysmal nocturnal dyspnea, lower limb edema, lung auscultation rale, etc.
- Left ventricular ejection fraction measured by echocardiogram ≤ 45% and patients had elevated level of NT-proBNP (patients<55 years, NT-proBNP>450 pg/mL; patients≥55 years and <75 years, NT-proBNP>900 pg/mL; patients ≥ 75 years, NT-proBNP>1800 pg/mL)
- New York Heart Association functional class II to IV.
Key exclusion criteria (15 listed)
- Left ventricular ejection fraction measured by echocardiogram > 45% or diagnosed with heart failure with preserved ejection fraction.
- Age ≤ 18 years old.
- Allergic to anti-heart failure medications including ACEI/ARB/ARNI, beta blockers, SGLT2i, oral diuretics and vericiguat.
- Diagnosed as other diseases with symptoms similar to heart failure such as acute exacerbation of chronic obstructive pulmonary disease, etc.
- Dignosed with acute coronary syndrome, including unstable angina, non ST-elevation myocardial infarction and ST-elevation myocardial infarction. Received percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to the trial start, or indication for PCI or CABG at the trial start.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guideline-Directed Medication Treatment (GDMT)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 | Other | Heart Failure Patients who were tolerable to GDMT |
Primary outcome
Worsening heart failure events in 180 days
Time frame: 180 days
Risk of death, readmission due to heart failure or accepting intravenous diuretic therapy in 180 days
7 secondary outcomes
Change in N-terminal pro-B type natriuretic peptide
Time frame: 180 days
Change in left ventricular ejection fraction (LVEF)
Time frame: 180 days
Change in left ventricular end-diastolic diameter (LVEDD)
Time frame: 180 days
Change in left ventricular end-systolic diameter (LVESD)
Time frame: 180 days
Change in left ventricular fractional shortening (LVFS)
Time frame: 180 days
Change in blood pressure
Time frame: 180 days
Change in blood potassium
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: PubMed 32222134Armstrong 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.
- Background: PubMed 29032136Armstrong 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.
- Background: PubMed 35363499Heidenreich 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.
- Background: PubMed 34447992McDonagh 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.
- Background: PubMed 36356631Mebazaa 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.
- Derived from this study: PubMed 41848038Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongying Zhang, Ph.D study chair
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Reduced Ejection Fraction, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worsening heart failure events in 180 days (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05799638, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.