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

Completed

• Conditions: Heart Failure With Reduced Ejection Fraction
• Interventions: Other: Guideline-Directed Medication Treatment (GDMT)

• Registration Number: NCT05799638
• Lead Sponsor: Chongqing Medical University

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.

Detailed Description

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

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-03-12
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-05
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart Failure Patients who were tolerable to GDMT	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.

Primary Outcome Measures

Name	Time	Method
Worsening heart failure events in 180 days	180 days	Risk of death, readmission due to heart failure or accepting intravenous diuretic therapy in 180 days

Secondary Outcome Measures

Name	Time	Method
Change in N-terminal pro-B type natriuretic peptide	180 days	Change in NT-proBNP level from baseline to 180 days or endpoint
Change in left ventricular end-systolic diameter (LVESD)	180 days	Change in LVESD measured by echocardiogram from baseline to 180 days or endpoint
Change in blood pressure	180 days	Systolic and diastolic blood pressures were measured at admission, discharge, and up-titration to the maximum tolerated dosage
Change in left ventricular fractional shortening (LVFS)	180 days	Change in LVFS measured by echocardiogram from baseline to 180 days or endpoint
Change in left ventricular end-diastolic diameter (LVEDD)	180 days	Change in LVEDD measured by echocardiogram from baseline to 180 days or endpoint
Change in blood potassium	180 days	Blood potassium were measured in baseline and endpoint
Change in left ventricular ejection fraction (LVEF)	180 days	Change in LVEF measured by echocardiogram from baseline to 180 days or endpoint

Trial Locations

Locations (1)

The first affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China