Description:

ODM derived from http://clinicaltrials.gov/show/NCT00558584

Link:

http://clinicaltrials.gov/show/NCT00558584

Keywords:
Versions (3) ▾
  1. 12/10/13
  2. 4/14/14
  3. 9/20/21
Uploaded on:

September 20, 2021

DOI:
No DOI assigned. To request one please log in.
License:
Creative Commons BY 4.0
Model comments:

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for:

Item comments for:

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT00558584 Dilated Cardiomyopathy

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age 18 Years to 65 Years
Dilated cardiomyopathy
LVEF <= 40% determined by contrast echocardiography
NYHA class II - IV
Age 18 - 65
Disease duration: symptomatic heart failure >1 year and <5 years prior to screening date
Treatment with ACE inhibitors or angiotensin II receptor blockers (ARB), beta-blockers, and aldosterone antagonists (the latter at the discretion of the attending physician), for at least 6 months and at stable doses for at least 2 months prior to screening date.
Informed Consent
Exclusion Criteria
NYHA class IV patients who are bed-ridden and dependent upon parenteral medication
Cardiac insufficiency resulting from another basic disease (e.g. coronary artery disease, >= 50% stenosis of major vessel as ascertained by coronary angiography performed more recent than three years before screening date, hypertensive heart disease, or valvular defects >second degree
History of - myocardial infarction
Acute myocarditis according to Dallas criteria
Endocrine disorder excluding insulin-dependent diabetes mellitus
Implanted cardiac defibrillator (ICD) <1 month before screening date
Cardiac resynchronization therapy (CRT) <6 months before screening date
I.v. medication with inotropic drugs, vasodilators or repeated (>1/day) i.v. administration of diuretics.
Active infectious disease, or signs of ongoing infection with CRP >10mmol/L
Impaired renal function (serum creatinine >220 µmol/L)
Any disease requiring immunosuppressive drugs
Anaemia (haemoglobin below 90 g/L) due to other causes than CHF
Pregnancy or lactation, or childbearing potential without appropriate contraception
Alcohol or drug abuse
Presence of a malignant tumour, or remission of malignancy < 5 years
Suspected poor capability to follow instructions and cooperate
Another life-threatening disease with poor prognosis (survival < 2 years)
Participation in any other clinical study within < 30 days prior to screening date
Previous treatments with IA or immunoglobulin
Contraindications for application of echocardiography contrast agent (Luminity(R) according to Luminity(R) specifications, including cardiac shunts, pulmonary vascular compromise)

Similar models