Visualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiency

• Register: EUCTR
• Last refreshed on: 21 December 2021
• Main ID: EUCTR2006-001574-24-NL
• Date of registration: 15/06/2006
• Prospective Registration: Yes
• Primary sponsor: Radboud University Nijmegen Medical Centre, Department of Endocrinology
• Public title: Visualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiency
• Scientific title: Visualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiency
• Date of first enrolment: 06/10/2006
• Target sample size: 30
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001574-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: untreated vs treated
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Netherlands

Key inclusion & exclusion criteria

Inclusion criteria:
1. Biochemically proven GH deficiency
2. Age between 35 and 60 years
3. GH deficient within half a year of neurosurgical procedure or GH deficient at least 5 years
4. Optimal substitution of other hormones
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. BMI >30
2. Positive history of myocardial or valve or coronary disease or symptoms that suggest coronary disease (chest pain in rest or during exercise)
3. Rhythm disturbances
4. Moderate or severe pulmonary disease
5. Impairment in renal function (Creatinin clearance < 60 ml/min)
6. Positive family history of primary dyslipidemia
7. Positive family history from premature cardiovascular disease
8. Positive family history of diabetes type II
9. Allergy for contrast
10. Claustrophobia


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with adult-onset growth hormone deficiency and the presence of atherosclerotic disease in the coronary arteries

Intervention(s)

Trade Name: Genotropin
Product Name: genotropin
Product Code: RVG 15790 or RVG 25480
Pharmaceutical Form: Concentrate for solution for injection

Primary Outcome(s)

Primary end point(s): 1. Presence of atherosclerotic disease in the coronary system (scored in an established (blinded) protocol as the level of stenosis within coronary segments and the level of intracoronary calcium)

Secondary Objective: Patients with a hypopituitarism and AGHD display additional proatherogenic mechanisms: 2.1 disturbances in antioxidant capacity of the high-density lipoprotein (HDL) fraction, 2.2 disturbances in the differentiation of endothelial progenitor cells with a less capacity to repair damaged endothelium, 2.3 an increase of metalloproteinases as part of the pro-inflammatory profile in circulation .

Main Objective: Hypothesis:

1. Patients who suffer from a hypopituitarism and an adult-onset growth hormone deficiency (AGHD) express more atherosclerotic disease in the coronary system (compared with a historically formed control subjects, present as a database in the cardiology department from the UMC Utrecht)
2. Atherosclerotic disease in the coronary system wil be in regression after one year substitution with recombinant human growth hormone (in line with previously published results with regard to carotid IMT)

Secondary ID(s)

13041970

Ethics review

Status: Approved
Approval date: 12/09/2006
Contact: