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

Phase 1

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

• Registration Number: EUCTR2006-001574-24-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre, Department of Endocrinology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-15
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified