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:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT00344734
Eligibility Criteria:
Inclusion Criteria:
Healthy controls
* Age 20 to 60 years
* Both men and women
* Weight below 100 kg
* Normal clinical examination and laboratory screening
* Fertile women only if using contraception
* Informed consent according to the regulations of the local ethics committee
Heart failure
* Both men and women
* Age 20 to 75 years
* Patients with heart failure in NYHA group II-III. Heart failure must be derived from ischaemic heart disease or dilated cardiomyopathy. Diagnosis must be verified by history and echocardiography or isotope cardiography.
* ejection fraction \< 0.40
* P-creatinin \< 250 µmol/L
* Fertile women only if using contraception
* Informed consent according to the regulations of the local ethics committee
Exclusion Criteria:
Healthy controls
* History or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening
* Current medication
* Drugs or alcohol abuse
* Pregnancy
* Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
* Donation of blood less than 1 month before the experiments
Heart failure
* Cardiac valvular disease with stenosis
* Significant cardiac arrythmia
* Myocardial infarction, PTCA or by-pass surgery less than 3 months before the study
* Diseases of the lever, kidneys, lungs or endocrine organs which are not secondary to congestive heart failure
* Arterial hypertension
* Neoplastic disease
* Cerebrovascular insult
* Treatment with ACE-inhibitors or nitrates which cannot be stopped 1 week before study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT00344734
Study Brief:
Protocol Section:
NCT00344734