Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000267954
Ethics application status
Approved
Date submitted
24/12/2010
Date registered
11/03/2011
Date last updated
11/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of preoperative sildenafil on patients with severe pulmonary hypertension undergoing heart valve replacement.
Scientific title
Observational study of the effects of preoperative Sildenafil on patients with pulmonary hypertension and valvular heart disease undergoing valve replacement surgery; To determine whether sildenfil reduces pulmonary pressures and examine whether this has any clinical significance in terms of morbidity and mortality
Secondary ID [1] 253174 0
N/A
Universal Trial Number (UTN)
U1111-1118-3007
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 258715 0
Valvular Heart Disease 258716 0
Condition category
Condition code
Cardiovascular 258870 258870 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of changes in cardiorespiratory parameters over the course of valve replacement surgery in patients with severe pulmonary hypertension. Patients were were given oral tablet of sildenafil 25mg three times per day in the 48 hour preoperative period in order to reduce pulmonary pressures prior to surgery. The initial observational period will be one year.
Intervention code [1] 257668 0
Not applicable
Comparator / control treatment
Changes in Pulmonary arterial pressures within same patient before and after sildenafil administration
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259729 0
Reduction in pulmonary pressures after administration of sildenafil. This will be assessed using pre-operative transthoracic echo, intraoperative trans oesophageal echo, and post operative pulmonary artery catheter measurements. Comparison will be made to pre-intervention TTE and right heart study findings.
Timepoint [1] 259729 0
peri-operative period
Primary outcome [2] 259730 0
Incidence of Right Ventricular failure. This will be assessed by review of patients clinical peri and post op course and findings from transoesophageal echo, pulmonary artery catheters etc
Timepoint [2] 259730 0
Peri and post operative period
Secondary outcome [1] 266461 0
30 day/ in hospital all cause mortality. as assessed by review of medical records
Timepoint [1] 266461 0
30 days post op
Secondary outcome [2] 266462 0
Post operative ventilation duration. This is determined by the time between arrival in ICU and extubation of patient.
Timepoint [2] 266462 0
the total number of hours / days of ventilation as documented in the ICU record for each patient
Secondary outcome [3] 266463 0
Length of ICU stay as documented in medical record. This is the time between arrival in ICU from the operating room until discharged to the ward.
Timepoint [3] 266463 0
Number of hours/ days spent in ICU. This will be documented during data collection

Eligibility
Key inclusion criteria
All patients undergoing valve replacement surgery who have concurrent severe pulmonary hypertension (>50mmHg or > 40mmHg with evidence of right ventricular failure)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria as all patients who meet the inclusion criteria will be included in this observational study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 3068 0
New Zealand
State/province [1] 3068 0

Funding & Sponsors
Funding source category [1] 258144 0
Hospital
Name [1] 258144 0
Waikato Hospital
Country [1] 258144 0
New Zealand
Primary sponsor type
Individual
Name
Richard Renew
Address
Anaesthetics Dept
Waikato Hospital
Pembroke St
Private Bag 3200
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 257311 0
Hospital
Name [1] 257311 0
Waikato Hospital
Address [1] 257311 0
Pembroke St Private Bag 3200 Hamilton 3240
Country [1] 257311 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260122 0
Northern Y Ethics Committee
Ethics committee address [1] 260122 0
Ethics committee country [1] 260122 0
New Zealand
Date submitted for ethics approval [1] 260122 0
30/11/2010
Approval date [1] 260122 0
07/03/2011
Ethics approval number [1] 260122 0
NTY/11/01/011

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31956 0
Address 31956 0
Country 31956 0
Phone 31956 0
Fax 31956 0
Email 31956 0
Contact person for public queries
Name 15203 0
Richard Renew
Address 15203 0
Anaesthetic Department Waikato Hospital Pembroke Street Private Bag 3200 Hamilton 3240
Country 15203 0
New Zealand
Phone 15203 0
+64 78398899
Fax 15203 0
Email 15203 0
[email protected]
Contact person for scientific queries
Name 6131 0
Richard Renew
Address 6131 0
Anaesthetic Department Waikato Hospital Pembroke Street Private Bag 3200 Hamilton 3240
Country 6131 0
New Zealand
Phone 6131 0
+64 78398899
Fax 6131 0
Email 6131 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.