Metoprolol in Patients With HFrEF and COPD

Metoprolol in Patients With Heart Failure With Reduced Ejection Fraction and Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure With Reduced Ejection Fraction (HFrEF); COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Drug: Different doses of Metoprolol.

• Study Type: Interventional
• Enrollment (Estimated): 311
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; The experimental group received the maximum tolerable dose of Metoprolol.	Drug: Different doses of Metoprolol.; The control group received 23.75mg/d of metoprolol, and the experimental group received the maximum tolerable dose of metoprolol.
Active Comparator: Control Group; The control group received 23.75mg/d of Metoprolol.	Drug: Different doses of Metoprolol.; The control group received 23.75mg/d of metoprolol, and the experimental group received the maximum tolerable dose of metoprolol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite endpoints (all-cause death and rehospitalization)	Rehospitalization included readmission for heart failure and/or COPD.	From enrollment to the end of treatment at 24 months.

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause death	From enrollment to the end of treatment at 24 months.
Cardiovascular death	From enrollment to the end of treatment at 24 months.
Rehospitalization for heart failure	From enrollment to the end of treatment at 24 months.
Re-hospitalization for COPD	From enrollment to the end of treatment at 24 months.

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Heart Failure with Reduced Ejection Fraction; Metoprolol
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Heart Failure; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Anti-Arrhythmia Agents; Adrenergic Agents; Antihypertensive Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Adrenergic beta-Antagonists; Adrenergic Antagonists; Metoprolol
• Other Study ID Numbers: 202412231; 2022YFC2010004 (Other Grant/Funding Number: National key research and development plan)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No