Metoprolol in Patients With HFrEF and COPD

NCT ID: NCT06825728

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2028-02-29

Brief Summary

The goal of the clinical trial was to see if Metoprolol was effective in treating patients with heart failure and chronic obstructive pulmonary disease. It will also learn about the safety of Metoprolol. The main questions it aims to answer are:

Did Metoprolol reduce the frequency of all-cause deaths and re-hospitalizations in subjects? What medical problems do participants experience after taking Metoprolol? The researchers will compare different doses of Metoprolol to see the best dose for Metoprolol.

Participants will:

Take Metoprolol 23.75mg/ day or the maximum tolerable dose of Metoprolol daily for 24 months.

Regular outpatient follow-up visits to the research center. Their symptoms and Metoprolol dosage were recorded.

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF); COPD (Chronic Obstructive Pulmonary Disease)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

The experimental group received the maximum tolerable dose of Metoprolol.

Group Type: EXPERIMENTAL

Different doses of Metoprolol.

Intervention Type: DRUG

The control group received 23.75mg/d of metoprolol, and the experimental group received the maximum tolerable dose of metoprolol.

Control Group

The control group received 23.75mg/d of Metoprolol.

Group Type: ACTIVE_COMPARATOR

Different doses of Metoprolol.

Intervention Type: DRUG

The control group received 23.75mg/d of metoprolol, and the experimental group received the maximum tolerable dose of metoprolol.

Interventions

Different doses of Metoprolol.

The control group received 23.75mg/d of metoprolol, and the experimental group received the maximum tolerable dose of metoprolol.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. A definite diagnosis of HFrEF (LVEF≤40%), NYHA II to IV , and the disease is due to ischemic heart disease or dilated cardiomyopathy;

2. A definite diagnosis of COPD with moderate or higher airflow limitation (FEV1/FVC < 0.7 and FEV1 < 80% of the expected value);

3. Age ≥18 years old;

4. Informed consent has been obtained and signed.

Exclusion Criteria

1. the dose of Metoprolol before enrollment was more than 23.75mg/d;

2. Resting heart rate < 50 beats/min;

3. Second or third degree atrioventricular block;

4. Atrial fibrillation;

5. Sick sinus syndrome;

6. Systolic blood pressure < 90mmHg;

7. Acute attack of bronchial asthma;

8. Liver insufficiency (serum transaminase > 3 times the normal value);

9. Renal insufficiency (eGFR < 30ml/min/1.73m2, or serum creatinine > 2.5mg/dL[> 221μmol/L]);

10. Patients with serious physical diseases, such as cancer;

11. Patients who have a history of allergy to the investigational drug or its ingredients;

12. Participating in other clinical investigators;

13. During the study period, Patients cannot live in the selected center for a long time, which is not conducive to the follow-up;

14. Patients with disability, mobility disability, intellectual disability and other factors that may prevent normal participation in the study and follow-up, and their frailty was assessed by the FRAIL frailty screening scale; Intellectual mental status was assessed by the Mini-Mental State Examination (MMSE).

15. Poor adherence or other reasons considered by the researchers to be unsuitable for the clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2022YFC2010004

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

202412231

Identifier Type: -

Identifier Source: org_study_id