TS HYPE - Turner syndrome and Hypertension; a double-blinded randomised interventional trial.

Conditions: Turner syndrome, hypertension and aortopathy
MedDRA version: 9.1Level: LLTClassification code 10045181Term: Turner's syndrome
MedDRA version: 9.1Level: LLTClassification code 10020772Term: Hypertension

Registration Number: EUCTR2009-010280-17-DK

Lead Sponsor: Organisation name was not entered

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 120

Inclusion Criteria

1.TS as verified through chromosomal genotyping.
2.Age > 18 years.
3.Hypertension defined as: a) 24-hour ambulatory blood pressure with 24-hour blood pressure > 118/75 mmHg, daytime values > 125/80 mmHg, and/or: night-time values > 102/66 mmHg 28, 29. b) Hypertension as documented with earlier clinical or ambulatory hypertension by a medical doctor with subsequent commencement anti-hypertensive medications.
4.Expected stationary status of either ongoing or absent oral oestrogen substitution therapy (HRT).
5.Informed consent – in writing and orally, as well as written authority.
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Contraindication to performing MR scans:
a)Claustrophobia,
b)Magnetic or electric foreign bodies – including; cardiac pacemakers, magnetic cerebrovascular clips and electric non-removable appliances dosing medicine and/or:
c)Extreme adiposity (BMI > 35 kg/m2).
2. Contraindication to BB therapy
a)Allergy to the ingredients,
b)Significant bradycardia or advanced atrioventricular block,
c)Decompensated heart failure and/or:
d)Asthma bronchiale.
3. Contraindications to ARB therapy:
a)Allergy to the ingredients,
b)Pregnancy, and/or:
c)Known renal artery stenosis, severe renal insufficiency.
d)Severe hepatic failure, biliary cirrhosis and cholestasis
4. Mechanical aortic valve or aortic prosthesis
5. Former or present malignant disease.
6. Diagnosed chronic liver disease (hepatitis or cirrhosis), as elevated liver enzymes are a common finding regarded as non-specific.
7. Other severe acute or chronic disease of known or presumed influence on the parameters of the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: ;Primary end point(s): The trial is thought as a hypothesis generating study concerning attenuation of cardiovascular risk in hypertensive Turner patients with different antihypertensive interventions. <br><br>Thus, the endpoints are direct and surrogate parameters of blood pressure, vasculopathy, cardiac funtion as well as metabolism. ;Main Objective: To compare the impact of carvedilol to that of losartan on different indices of cardiovascular risk in hypertensive patients with Turner syndrome.

Secondary Outcome Measures