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

Chongqing Medical University

Status and phase: Completed; Phase 4

Conditions: Heart Failure With Reduced Ejection Fraction

Treatments: Other: Guideline-Directed Medication Treatment (GDMT)

Study type: Observational

Funder types: Other

Identifiers

NCT05799638

SEMI-HF

Details and patient eligibility

About

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.

Full description

The study aim to provide evidence of medication strategy in heart failure patients, especially for patients who are intolerable for GDMT.

Enrollment: 263 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Sent to the Department of Cardiovascular disease of The First Affiliated Hospital of Chongqing Medical University for inpatient treatment.
2. Diagnosed with acute heart failure or acute exacerbation of chronic heart failure
3. Patients with typical heart failure symptoms and signs such as dyspnea, fatigue after exercise, paroxysmal nocturnal dyspnea, lower limb edema, lung auscultation rale, etc.
4. 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)
5. New York Heart Association functional class II to IV.

Exclusion criteria

1. Left ventricular ejection fraction measured by echocardiogram > 45% or diagnosed with heart failure with preserved ejection fraction.
2. Age ≤ 18 years old.
3. Allergic to anti-heart failure medications including ACEI/ARB/ARNI, beta blockers, SGLT2i, oral diuretics and vericiguat.
4. Diagnosed as other diseases with symptoms similar to heart failure such as acute exacerbation of chronic obstructive pulmonary disease, etc.
5. 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.
6. Hepatic insufficiency classified as Child-Pugh B or C.
7. Diagnosed with restrictive cardiomyopathy.
8. Diagnosed with cardiac amyloidosis, Fabry disease or other rare cardiomyopathy.
9. Diagnosed with systematic lupus erythematosus or other autoimmune disease.
10. Diagnosed with or suspect diagnosed with active tumor.
11. Diagnosed with idiopathic pulmonary hypertension, receiving PDE-5 inhibitor or other sGC stimulators.
12. Pregnant woman.
13. Combined with severe infection at admission or combined with uncontrolled tuberculosis.
14. Diagnosed with severe and uncontrolled congenital heart disease.
15. Patients with rheumatic valvular disease who have indications for surgery but have not undergone surgical treatment.

Trial design

263 participants in 2 patient groups

Heart Failure Patients who were tolerable to GDMT

Description:

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.

Treatment:

Other: Guideline-Directed Medication Treatment (GDMT)

Heart Failure Patients who were intolerable to GDMT

Description:

The patients in this group were intolerable to one or more medication in GDMT due to hypotension, hyperkalemia or renal insufficiency.