Hyperaldosteronism Clinical Trial
— AVISOfficial title:
Multicenter Study on Use and Interpretation of Adrenal Vein Sampling
Verified date | January 2013 |
Source | University Hospital Padova |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
The AVIS Study is a retrospective multicenter international study that aims to answer a
series of questions on the use and performance of adrenal venous catheterization (AVS) for
the diagnosis of primary hyperaldosteronism subtype. A questionnaire will be circulated
among the centres that are internationally recognized and have published in the field of AVS
and have agreed to participate in the study.
The first aim of the AVIS study is to collect summary data on how AVS is being performed
throughout the world to answer the following questions:
- How many AVS studies haw been performed yearly from 2005 to 2010 at each center?
- How many adrenal vein ruptures occurred during the AVS at each center?Has the rate of
adrenal vein rupture been steady or has it changed over the 5 years?
- How many centers use bilaterally simultaneous and how many use sequential AVS
catheterization?
- How many radiologists perform AVS at each center?
- How many centers use a cosyntropin stimulation during AVS?
- What is the percentage of PA patients in whom AVS is performed?
- How many centres calculate the selectivity index? What is the minimum cutoff used?
- How many centers calculate the lateralization index? What is the minimum cutoff used?
- Are the AVS studies that are not bilaterally selective used for diagnosis?
- How many centers calculate the controlateral suppression index and what is the minimum
cutoff used?
- What is the cost of AVS for the National Health System or Insurance and for patients?
The second aim of the study is to calculate the rate of AVS studies that are selective
and show lateralization of aldosterone excess at each center by applying predefined set
of criteria for defining selectivity and lateralization. Data on the final diagnosis of
the PA subtype will be gathered and used as reference to assess the performance of AVS
using receiver operating characteristic curves analysis and the Youden index to
determine the optimal cutoffs. A worksheet will need to be completed providing
information on the following: Demography; Date of AVS;Baseline blood pressure (BP)
values and serum K+;Dynamic test during the AVS if any; plasma aldosterone and cortisol
concentration in the infra-adrenal inferior vena cava and in the right and left adrenal
vein; diagnosis of PA subtype; treatment (adrenalectomy or pharmacological therapy);
post-treatment BP and serum K+ values; concordance/discordance between imaging (CT or
RM) and AVS.
Status | Completed |
Enrollment | 2604 |
Est. completion date | November 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - consent of the leading investigator to participate to the data collection Exclusion Criteria: - refusal of the leading investigator to participate to the AVIS Study |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Australia | Endocrine Hypertension Research Centre, University of Queensland School of Medicine, Greenslopes Hospital | Brisbane | |
Canada | Foothills Medical Centre, University of Calgary | Calgary | Alberta |
Canada | Centre Hospitalier de l'Université de Montreal (CHUM) | Montreal | Quebec |
Czech Republic | General Faculty Hospital, Prague | Prague | |
France | University of Paris, Hopital Européen Georges Pompidou | Paris | |
Germany | Christian J Strasburger | Berlin | |
Germany | Heinrich Heine Universität Düsseldorf | Düsseldorf | |
Germany | Medizinische Klinik Innenstadt | Munich | |
Germany | University Hospital Wuerzburg | Wuerzburg | |
Italy | Dept Clinical and Experimental Medicine (DMCS), University Hospital of Padova, Italy | Padua | |
Italy | Medicina 2, Dipartimento di Medicina Interna e Specialità Mediche, Azienda Ospedaliera Santa Maria Nuova | Reggio Emilia | |
Japan | National Hospital Organizatio, Kyoto Medical Center | Kyoto | |
Japan | Tohoku University Hospital | Sendai | |
Japan | Institute of Clinical Endocrinology, Tokyo Women's Medical University | Tokyo | |
Japan | Yokohama Rosai Hospital | Yokohama City | |
Netherlands | Radboud University Nijmegen Medical Center | Nijmegen | |
Taiwan | National Taiwan University Hospital | Taipei | |
United States | UT Southwestern Medical Center | Dallas | Texas |
United States | Medical College of Wisconsin | Menomonee Falls | Wisconsin |
United States | Hospital of The University of Pennsylvania, Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University Hospital Padova |
United States, Australia, Canada, Czech Republic, France, Germany, Italy, Japan, Netherlands, Taiwan,
Auchus RJ, Wians FH Jr, Anderson ME, Dolmatch BL, Trimmer CK, Josephs SC, Chan D, Toomay S, Nwariaku FE. What we still do not know about adrenal vein sampling for primary aldosteronism. Horm Metab Res. 2010 Jun;42(6):411-5. doi: 10.1055/s-0030-1252060. Epub 2010 Apr 21. Review. — View Citation
Funder J, Carey R, Fardella C, Gomez-Sanchez C, Mantero F, Stowasser M, Young W, Montori VM. Case detection, diagnosis, and treatment of patients with primary aldosteronism: an Endocrine Society clinical practice guideline. Eur J Endocrinol. 2009 Sep 30. [Epub ahead of print] — View Citation
Mulatero P, Bertello C, Sukor N, Gordon R, Rossato D, Daunt N, Leggett D, Mengozzi G, Veglio F, Stowasser M. Impact of different diagnostic criteria during adrenal vein sampling on reproducibility of subtype diagnosis in patients with primary aldosteronism. Hypertension. 2010 Mar;55(3):667-73. doi: 10.1161/HYPERTENSIONAHA.109.146613. Epub 2010 Feb 1. — View Citation
Nishikawa T, Saito J, Omura M. Adrenal venous sampling is absolutely requisite for definitively diagnosing primary aldosteronism as well as for detecting laterality of the adrenal lesion. Hypertens Res. 2007 Nov;30(11):1009-10. doi: 10.1291/hypres.30.1009. — View Citation
Rossi GP, Pitter G, Bernante P, Motta R, Feltrin G, Miotto D. Adrenal vein sampling for primary aldosteronism: the assessment of selectivity and lateralization of aldosterone excess baseline and after adrenocorticotropic hormone (ACTH) stimulation. J Hypertens. 2008 May;26(5):989-97. doi: 10.1097/HJH.0b013e3282f9e66a. — View Citation
Seccia TM, Miotto D, De Toni R, Pitter G, Mantero F, Pessina AC, Rossi GP. Adrenocorticotropic hormone stimulation during adrenal vein sampling for identifying surgically curable subtypes of primary aldosteronism: comparison of 3 different protocols. Hypertension. 2009 May;53(5):761-6. doi: 10.1161/HYPERTENSIONAHA.108.128553. Epub 2009 Apr 6. — View Citation
Stewart PM, Allolio B. Adrenal vein sampling for Primary Aldosteronism: time for a reality check. Clin Endocrinol (Oxf). 2010 Feb;72(2):146-8. doi: 10.1111/j.1365-2265.2009.03714.x. Epub 2009 Sep 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of adrenal vein ruptures occurring during AVS | January 1st 2005 - November 1st 2010 | No | |
Secondary | AVS cost for the patient and the health insurance system | The amount in euros that the patient and the health insurance system has to pay for the AVS study will be estimated in each center. | January 1st 2005 - November 1st 2010 | No |
Secondary | number of selective AVS at right or left side | The number of selective AVS at right or left side will be calculated using different cutoff values for the selectivity index. | January 1st 2005 - November 1st 2010 | No |
Secondary | number of bilaterally selective AVS | The number of bilaterally selective AVS will be calculated using different cutoff values for the selectivity index. | January 1st 2005 - November 1st 2010 | No |
Secondary | number of lateralized AVS and number of the patients undergoing adrenalectomy | The number of lateralized AVS will be calculated using different cutoff values for the lateralization index. | January 1st 2005 - November 1st 2010 | No |
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