Strategy, Efficacy and Safety of Medication Usage in Heart Failure Patients Who Were Intolerable to GDMT

NCT05799638 | Completed

• 1 other identifier: SEMI-HF
• Study Type: observational
• Target: 263
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

heart failure; myocardial fibrosis; vericiguat

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Change in N-terminal pro-B type natriuretic peptide

  180 days

• Change in left ventricular ejection fraction (LVEF)

  180 days

• Change in left ventricular end-diastolic diameter (LVEDD)

  180 days

• Change in left ventricular end-systolic diameter (LVESD)

  180 days

• Change in left ventricular fractional shortening (LVFS)

  180 days

Study Arms (2)

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.

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.

Interventions

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

Heart Failure Patients who were tolerable to GDMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

The first affiliated Hospital of Chongqing Medical University

Chongqing, 400042, China

Location

Related Publications (5)

• 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.

  PMID: 32222134 BACKGROUND

• 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.

  PMID: 29032136 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.

  PMID: 35363499 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.

  PMID: 34447992 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.

  PMID: 36356631 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Dongying Zhang, Ph.D

  First Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: April 5, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)