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

March 15, 2024 updated by: Dongying Zhang, Chongqing Medical University

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

SEMI trial is a single-center, observational, 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chongqing, China, 400042
        • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion criteria:

  1. Age ≥ 18 years
  2. Hospitalization and diagnosed with acute heart failure with typical symptoms and signs, such as dyspnea, shortness of breath and edema.
  3. LVEF measured by echocardiogram ≤ 45%.
  4. Patients with elevated NT-proBNP (NT-proBNP ≥ 125 pg/ml in sinus rate or ≥ 350 pg/ml in atrial fibrillation)

Exclusion criteria:

  1. LVEF measured by the UCG>45%
  2. Used to diagnosed with heart failure with preserved ejection fraction.
  3. Age ≤18 years.
  4. Using or planned to be implanted with a ventricular assist device.
  5. Severe and uncontrolled pulmonary disease, such as pneumoconiosis, newly developed pulmonary embolism, or chronic obstructive pulmonary disease requiring long-term oxygen therapy.
  6. Severe and uncontrolled liver disease with Child-Pugh class C.
  7. History of allergic or hypersensitivity to ACEIs, ARBs, ARNI, β blockers, SGLT2is, MRAs and vericiguat.
  8. Patients diagnosed with active myocarditis.
  9. Probable alternative diagnoses could account for the patient's HF symptoms e.g., bronchial asthma, primary pulmonary hypertension.
  10. Pregnant woman
  11. Fatal or uncontrollable heart arrythmia e.g., symptomatic or persistence ventricular tachycardia, ventricular rate>150 bpm in AF patients.
  12. Obvious stenosis of bilateral renal arteries.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality or worsening heart failure in 180 days
Time Frame: 180 days
Risk of all-cause death, readmission due to heart failure or accepting intravenous diuretic therapy in 180 days
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in symptoms and signs of heart failure
Time Frame: 180 days
Change in symptoms and signs of heart failure measured by New York Heart Association (NYHA) class 1 to 4
180 days
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
180 days
Change in left ventricular ejection fraction (LVEF)
Time Frame: 180 days
Change in LVEF measured by echocardiogram from baseline to 180 days or endpoint
180 days
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
180 days
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
180 days
Change in left ventricular fractional shortening (LVFS)
Time Frame: 180 days
Change in LVFS measured by echocardiogram from baseline to 180 days or endpoint
180 days
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
180 days
Change in blood potassium
Time Frame: 180 days
Blood potassium were measured in baseline and endpoint
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Investigators

  • Study Chair: Dongying Zhang, Ph.D, First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 12, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEMI-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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