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NCT Number: NCT05799638

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The first affiliated Hospital of Chongqing Medical University

Chongqing, 400042, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in N-terminal pro-B type natriuretic peptide

    Time frame: 180 days

    Change in NT-proBNP level from baseline to 180 days or endpoint

  2. Change in left ventricular ejection fraction (LVEF)

    Time frame: 180 days

    Change in LVEF measured by echocardiogram from baseline to 180 days or endpoint

  3. Change in left ventricular end-diastolic diameter (LVEDD)

    Time frame: 180 days

    Change in LVEDD measured by echocardiogram from baseline to 180 days or endpoint

  4. Change in left ventricular end-systolic diameter (LVESD)

    Time frame: 180 days

    Change in LVESD measured by echocardiogram from baseline to 180 days or endpoint

  5. Change in left ventricular fractional shortening (LVFS)

    Time frame: 180 days

    Change in LVFS measured by echocardiogram from baseline to 180 days or endpoint

  6. Change in blood pressure

    Time frame: 180 days

    Systolic and diastolic blood pressures were measured at admission, discharge, and up-titration to the maximum tolerated dosage

  7. Change in blood potassium

    Time frame: 180 days

    Blood potassium were measured in baseline and endpoint

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study title

Medication Strategies in Heart Failure Patients Who Are Intolerable to Guideline-directed Medical Therapy

Acronym: SEMI

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 5, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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