Heart Failure With Reduced Ejection Fraction (HFrEF)Phase 4NCT06825728
Metoprolol in Patients With HFrEF and COPD
A Phase 4 study testing Different doses of Metoprolol. in people with Heart Failure With Reduced Ejection Fraction (HFrEF) and COPD (Chronic Obstructive Pulmonary Disease), run by Xiangya Hospital of Central South University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction (HFrEF), COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Different doses of Metoprolol.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Feb 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A definite diagnosis of HFrEF (LVEF≤40%), NYHA II to IV , and the disease is due to ischemic heart disease or dilated cardiomyopathy;
- A definite diagnosis of COPD with moderate or higher airflow limitation (FEV1/FVC < 0.7 and FEV1 < 80% of the expected value);
- Age ≥18 years old;
- Informed consent has been obtained and signed.
Who cannot join
- the dose of Metoprolol before enrollment was more than 23.75mg/d;
- Resting heart rate < 50 beats/min;
- Second or third degree atrioventricular block;
- Atrial fibrillation;
- Sick sinus syndrome;
- Systolic blood pressure < 90mmHg;
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- Acute attack of bronchial asthma;
- Liver insufficiency (serum transaminase > 3 times the normal value);
- Renal insufficiency (eGFR < 30ml/min/1.73m2, or serum creatinine > 2.5mg/dL[> 221μmol/L]);
- Patients with serious physical diseases, such as cancer;
- Patients who have a history of allergy to the investigational drug or its ingredients;
- Participating in other clinical investigators;
- During the study period, Patients cannot live in the selected center for a long time, which is not conducive to the follow-up;
- 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).
- Poor adherence or other reasons considered by the researchers to be unsuitable for the clinical trial.
About this study
Official title: 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.
Read more
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)
- Being tested
- Different doses of Metoprolol.
- Keywords
- Heart Failure with Reduced Ejection Fraction, Chronic Obstructive Pulmonary Disease, Metoprolol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different doses of Metoprolol.Drug
The control group received 23.75mg/d of metoprolol, and the experimental group received the maximum tolerable dose of metoprolol.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group received the maximum tolerable dose of Metoprolol. Receives: Drug: Different doses of Metoprolol. |
| Control Group | Active comparator | The control group received 23.75mg/d of Metoprolol. Receives: Drug: Different doses of Metoprolol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoints (all-cause death and rehospitalization)
Rehospitalization included readmission for heart failure and/or COPD.
Measured: From enrollment to the end of treatment at 24 months.
Secondary outcomes (4)
All-cause death
Measured: From enrollment to the end of treatment at 24 months.
Cardiovascular death
Measured: From enrollment to the end of treatment at 24 months.
Rehospitalization for heart failure
Measured: From enrollment to the end of treatment at 24 months.
Re-hospitalization for COPD
Measured: From enrollment to the end of treatment at 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection Fraction (HFrEF)Studies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 311 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825728
- Sponsor's protocol ID
- 202412231
- Other IDs
- 2022YFC2010004
- Status last verified
- Jan 2025
- First submitted
- 7 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metoprolol in Patients With Heart Failure With Reduced Ejection Fraction and Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06825728
- Acronym / sponsor ID
- 202412231
- Conditions
- Heart Failure With Reduced Ejection Fraction (HFrEF), COPD (Chronic Obstructive Pulmonary Disease)
- Keywords
- Heart Failure with Reduced Ejection Fraction, Chronic Obstructive Pulmonary Disease, Metoprolol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 311 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Different doses of Metoprolol.The experimental group received the maximum tolerable dose of Metoprolol. |
| Control Group | Active comparator | Drug: Different doses of Metoprolol.The control group received 23.75mg/d of Metoprolol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A definite diagnosis of HFrEF (LVEF≤40%), NYHA II to IV , and the disease is due to ischemic heart disease or dilated cardiomyopathy;
- A definite diagnosis of COPD with moderate or higher airflow limitation (FEV1/FVC < 0.7 and FEV1 < 80% of the expected value);
- Age ≥18 years old;
- Informed consent has been obtained and signed.
Key exclusion criteria (15 listed)
- the dose of Metoprolol before enrollment was more than 23.75mg/d;
- Resting heart rate < 50 beats/min;
- Second or third degree atrioventricular block;
- Atrial fibrillation;
- Sick sinus syndrome;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Different doses of Metoprolol.The control group received 23.75mg/d of metoprolol, and the experimental group received the maximum tolerable dose of metoprolol. | Drug | Control Group, Experimental Group |
Primary outcome
Composite endpoints (all-cause death and rehospitalization)
Time frame: From enrollment to the end of treatment at 24 months.
Rehospitalization included readmission for heart failure and/or COPD.
4 secondary outcomes
All-cause death
Time frame: From enrollment to the end of treatment at 24 months.
Cardiovascular death
Time frame: From enrollment to the end of treatment at 24 months.
Rehospitalization for heart failure
Time frame: From enrollment to the end of treatment at 24 months.
Re-hospitalization for COPD
Time frame: From enrollment to the end of treatment at 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Different doses of Metoprolol. in people with Heart Failure With Reduced Ejection Fraction (HFrEF) and COPD (Chronic Obstructive Pulmonary Disease), run by Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoints (all-cause death and rehospitalization) (time frame: From enrollment to the end of treatment at 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025; AzTrials last refreshed its copy on 1 Nov 2026.