NCT06825728Not yet recruitingPhase 4
Metoprolol in Patients With HFrEF and COPD
Metoprolol in Patients With Heart Failure With Reduced Ejection Fraction and Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov · Last updated 13 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 311 (estimated)
- First submitted
- 7 Feb 2025
- Start date
- Feb 2025
- Primary completion date
- Feb 2028
- Lead sponsor
- Xiangya Hospital of Central South University
- Diseases
- Heart failure, COPD
- NCT number
- NCT06825728
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 311
- From Feb 2025 to the primary completion date, Feb 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have a history of allergy to the investigational drug or its ingredients;
Other illness
- Resting heart rate \< 50 beats/min;
- Sick sinus syndrome;
- Patients with serious physical diseases, such as cancer;
Lab values
- Liver insufficiency (serum transaminase \> 3 times the normal value);
- Renal insufficiency (eGFR \< 30ml/min/1.73m2, or serum creatinine \> 2.5mg/dL\[\> 221μmol/L\]);
Other
- the dose of Metoprolol before enrollment was more than 23.75mg/d;
- Second or third degree atrioventricular block;
- Atrial fibrillation;
- Systolic blood pressure \< 90mmHg;
- Acute attack of bronchial asthma;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.