HemodialysisNCT01140490
Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients
A study testing Sub-total Parathyroidectomy in people with Hemodialysis, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The aim of this study was to evaluate whether successful sub-total parathyroidectomy retards cardiovascular calcification in patients with hemodialysis and to investigate the mechanism . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Sub-total Parathyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients receiving hemodialysis treatment, with elevated intact parathyroid hormone (iPTH) levels > 800pg/ml on two or more occasions.
- Patients with parathyroid nodular or diffuse hyperplasia identified by ultrasound imaging or radioisotope scan.
Who cannot join
- Patients with significant background valvular heart disease
- Patients who are unfit for general anaesthesia
- Patients with acute myocardial infarction within recent two months
- Patients with poor general condition
- Patients with plans for living related kidney transplant within 1 year
- Patients with previous history of parathyroidectomy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Liu shuangxin, MD and Phd, 8602083827812 ext. 62027, mplsxi@yahoo.com.cn
About this study
The aim of this study was to evaluate whether successful sub-total parathyroidectomy retards cardiovascular calcification in patients with hemodialysis and to investigate the mechanism .
Read the detailed description
Hyperparathyroidism (PHPT) in patients with end-stage renal disease have been shown to have an increased morbidity and mortality mainly due to cardiovascular disease. The precise mechanism of cardiovascular disease in PHPT is not well understood . The excess in cardiovascular mortality is significantly and independently related to serum calcium, the connection between the biochemical disturbances and the cardiovascular disorders in PHPT patients is not necessarily a cause-and-effect relationship. Indeed, the impact of surgical cure of hyperparathyroidism on cardiovascular risk factors and mortality is controversial. Some studies suggest that cardiovascular risk markers remained unaltered after Sub-total Parathyroidectomy.
- Conditions
- Hemodialysis
- Being tested
- Sub-total Parathyroidectomy
- Keywords
- Hemodialysis, Sub-total Parathyroidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-total ParathyroidectomyProcedure or surgery
Sub-total Parathyroidectomy
| Study group | Role | What they receive |
|---|---|---|
| Sub-total Parathyroidectomy | No intervention | Not described Receives: Procedure: Sub-total Parathyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vascular calcium scores
Measured: 12 months
Secondary outcomes (1)
Change in left ventricular systolic and diastolic function
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJan 2009
- Primary completionJan 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shi wei, MD PHD, Principal investigator, Chinese Nephrology Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140490
- Sponsor's protocol ID
- 8020
- Status last verified
- Jan 2009
- First submitted
- 7 Jun 2010
- Last updated
- 11 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients
- ClinicalTrials.gov ID
- NCT01140490
- Acronym / sponsor ID
- 8020
- Conditions
- Hemodialysis
- Keywords
- Hemodialysis, Sub-total Parathyroidectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate whether successful sub-total parathyroidectomy retards cardiovascular calcification in patients with hemodialysis and to investigate the mechanism .
Detailed description
Hyperparathyroidism (PHPT) in patients with end-stage renal disease have been shown to have an increased morbidity and mortality mainly due to cardiovascular disease. The precise mechanism of cardiovascular disease in PHPT is not well understood . The excess in cardiovascular mortality is significantly and independently related to serum calcium, the connection between the biochemical disturbances and the cardiovascular disorders in PHPT patients is not necessarily a cause-and-effect relationship. Indeed, the impact of surgical cure of hyperparathyroidism on cardiovascular risk factors and mortality is controversial. Some studies suggest that cardiovascular risk markers remained unaltered after Sub-total Parathyroidectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sub-total Parathyroidectomy | No intervention | Procedure: Sub-total Parathyroidectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patients receiving hemodialysis treatment, with elevated intact parathyroid hormone (iPTH) levels > 800pg/ml on two or more occasions.
- Patients with parathyroid nodular or diffuse hyperplasia identified by ultrasound imaging or radioisotope scan.
Key exclusion criteria (6 listed)
- Patients with significant background valvular heart disease
- Patients who are unfit for general anaesthesia
- Patients with acute myocardial infarction within recent two months
- Patients with poor general condition
- Patients with plans for living related kidney transplant within 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sub-total ParathyroidectomySub-total Parathyroidectomy | Procedure or surgery | Sub-total Parathyroidectomy |
Primary outcome
Change in vascular calcium scores
Time frame: 12 months
1 secondary outcome
Change in left ventricular systolic and diastolic function
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shi wei, MD PHD principal investigator
Chinese Nephrology Committee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sub-total Parathyroidectomy in people with Hemodialysis, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shi Wei, MD and PHD (8602083827812 ext. 62027, shiw_ggh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vascular calcium scores (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2011.