Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT00384566
Eligibility Criteria:
Inclusion Criteria:
* males and females over 18 years of age
* Documented CHF (NYHA class II-IV symptoms)
* Airflow obstruction defined as patients with symptomatic obstructive respiratory disease as manifest by any of the following Symptoms of wheeze, primarily attributed to airflow obstruction Requirement for intermittent or regular bronchodilator therapy FEV1 less than 70% predicted pre-salbutamol
* Confirmed written informed consent.
* Clinically indicated to receive β-blockade.
* No evidence of heart block on ECG.
* Patients will be in one of the following categories:
Currently on carvedilol Currently on Toprol-XL or Metoprolol tartrate Currently on bisoprolol Clinically indicated to receive β adrenoceptor blockade but not currently prescribed a β-blocker.
Exclusion Criteria:
* Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method.
* Patients who had received an investigational new drug within the last 4 weeks.
* Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
* Laboratory parameters:
Creatinine \>0.30 mmol/l Liver function tests 3x ULN
* Recent (\<12 months) myocarditis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00384566
Study Brief:
Protocol Section:
NCT00384566