Condition category
Circulatory System
Date applied
28/09/2006
Date assigned
28/09/2006
Last edited
08/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ccmo.nl

Contact information

Type

Scientific

Primary contact

Dr B J Bouma

ORCID ID

Contact details

Academic Medical Centre
Department of Cardiology
Room F3 - 115
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5666051
b.j.bouma@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CVAL489ANL09

Study information

Scientific title

Acronym

ARBs and systemic right ventricles.

Study hypothesis

Treatment with an angiotensin II receptor blocker (valsartan) stabilises or improves the functional performance of the systemic right ventricle.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Transposition of the great arteries, systemic right ventricle

Intervention

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

Intervention type

Drug

Phase

Not Specified

Drug names

Valsartan

Primary outcome measures

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

Secondary outcome measures

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?

Overall trial start date

01/09/2006

Overall trial end date

01/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

128

Participant exclusion criteria

1. Incapable of giving informed consen
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 more than 250 µmol/L
8. Plasma potassium level more than 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 Angiotensin Converting Enzyme (ACE) inhibitors

Recruitment start date

01/09/2006

Recruitment end date

01/01/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Novartis Pharma B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21095266
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23247302

Publication citations

  1. Protocol

    van der Bom T, Winter MM, Bouma BJ, Groenink M, Vliegen HW, Pieper PG, van Dijk AP, Sieswerda GT, Roos-Hesslink JW, Zwinderman AH, Mulder BJ, Rationale and design of a trial on the effect of angiotensin II receptor blockers on the function of the systemic right ventricle., Am. Heart J., 2010, 160, 5, 812-818, doi: 10.1016/j.ahj.2010.08.005.

  2. Results

    van der Bom T, Winter MM, Bouma BJ, Groenink M, Vliegen HW, Pieper PG, van Dijk AP, Sieswerda GT, Roos-Hesselink JW, Zwinderman AH, Mulder BJ, Effect of valsartan on systemic right ventricular function: a double-blind, randomized, placebo-controlled pilot trial., Circulation, 2013, 127, 3, 322-330, doi: 10.1161/CIRCULATIONAHA.112.135392.

Additional files

Editorial Notes