To investigate whether treatment with candesartan (ARB) reduce 24-hours systolic BP and aortic stiffness more effectively than treatment with metoprolol (beta-blocker) in patients with repaired CoA and late hypertension.
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter will be the reduction in 24-hours systolic blood
pressure after 8 weeks of active treatment.
Secondary outcome
The secondary study parameter will be the reduction in aortic stiffness as
assessed by aortic pulse wave velocity. Tertiary study parameters will be
changes in plasma values of NT-proBNP, rennin, aldosteron, noradrenalin,
adrenalin, and endothelin-1.
Background summary
Systemic hypertension is one of the major long-term problems following repair
of coarctation of the aorta (CoA). Research on specific treatment of
hypertension in these patients is not available and current treatment
strategies are based on hypertension treatment in other patient groups. In our
institution, most CoA patients with late hypertension receive different
antihypertensive agents (i.e. beta-blockers, ACE-inhibitors, angiotensin
receptor blockers (ARB), diuretics).
Study objective
To investigate whether treatment with candesartan (ARB) reduce 24-hours
systolic BP and aortic stiffness more effectively than treatment with
metoprolol (beta-blocker) in patients with repaired CoA and late hypertension.
Study design
Single center, open, randomised, cross-over study during a 1-year period.
Intervention
After a washout period of 3 weeks for patients previously on antihypertensive
agents, patients will be randomised to treatment with candesartan first (Group
A) or metoprolol first (Group B) for 8 weeks. After a washout period of 3
weeks, patient will receive the other active treatment for another 8 weeks.
Candesartan 8 mg and metoprolol 100 mg will be used, respectively.
Study burden and risks
The study period for the individual patient is approximately 6 months. During
this period, the subject will have 24-hours ambulatory BP monitoring on 4
different occasions. Furthermore, laboratory testing and ultrasound examination
will take place (4 times). Metoprolol and candesartan are widely prescribed
antihypertensive agents with low adverse events rates, and are currently also
used in CoA patients. The current study may provide valuable information
regarding the beneficial role of ARBs in CoA patients.
's Gravendijkwal 230
3015 CE Rotterdam
NL
's Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of aortic coarctation (EPCC code 09.29.01)
- Previous repair of aortic coarctation
- Age 18-80 years
- Current use of anti-hypertensive medication (<3 different drugs), or untreated hypertension, defined as systolic >=140 mmHg or diastolic >=90 mmHg
Exclusion criteria
- Known oversensitivity for candesartan or metoprolol
- Severe liver insufficiency (ASAT or ALAT >3ULN)
- Current use of >=3 anti-hypertensive drugs
- Pregnancy or wish to become pregnant
- General contraindications for use of candesartan
- General contraindications for use of metoprolol (i.e. bradycardia, sick sinus syndrome etc)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-006861-18-NL |
| CCMO | NL15692.078.06 |