Angiotensin II receptor blockers in patients with systemic right ventricles.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21444

Enrollment

128

Registered

2006-07-03

Start date

2006-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic right ventricle due to a congenitally or surgically corrected transposition of the great arteries.

Interventions

One group receives twice daily a 160 mg tablet of valsartan and the other group receives twice daily a placebo tablet.

Eligibility

Inclusion criteria

Inclusion criteria: All adult patients with a systemic right ventricle due to a congenitally or surgically corrected transposition of the great arteries.

Exclusion criteria

Exclusion criteria: 1. Incapable of giving informed consent; 2. Hypersensitivity to valsartan or any of its help substances; 3. Known bilateral renal artery stenosis; 4. Current symptomatic hypotension; 5. Myocardial infarction, stroke or open-heart surgery in the previous four weeks; 6. Previous heart transplant, or expected heart transplant within the next six months; 7. Plasma creatinine level > 250 µmol/L; 8. Plasma potassium level > 5,5 mmol/L; 9. Pregnant or nursing women (a pregnancy test is offered to every female patient within the fertile age); 10. Desire to have children within the study period; 11. Current treatment of hypertension with Angiotensin II receptor blockers or ACE inhibitors.

Design outcomes

Primary

Measure	Time frame
The change in right ventricular ejection fraction, determined by Cardiovascular Magnetic Resonance (CMR) (valsartan vs. placebo). In patients who are not eligible for CMR the right ventricular ejection fraction is determined by echocardiography.	—

Secondary

Measure	Time frame
1. changes congestive heart failure? 2. changes the prevalence of supra-ventricular arrhythmias? 3. changes in right ventricular function, determined by body surface mapping? 4. changes the right ventricular volume? 5. changes the peak oxygen consumption during exercise? 6. changes the serum neurohormone levels? 7. changes the quality of life and sport activity? 8. changes the cardiac output and microcirculation? 9. changes the number of deaths?	—

Measure

Time frame

1. changes congestive heart failure? 2. changes the prevalence of supra-ventricular arrhythmias? 3. changes in right ventricular function, determined by body surface mapping? 4. changes the right ventricular volume? 5. changes the peak oxygen consumption during exercise? 6. changes the serum neurohormone levels? 7. changes the quality of life and sport activity? 8. changes the cardiac output and microcirculation? 9. changes the number of deaths?

—

Contacts

Public ContactB.J. Bouma

Academic Medical Centre (AMC) Department of cardiology Room F3 – 115

b.j.bouma@amc.uva.nl+31 (0)20 5666051

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)