Trial Review

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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
3rd floor, BNZ building
354 Victoria St
PO Box 1031
Hamilton
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
Sildenafil is a drug that can be used to treat raised blood pressure within the lungs. In patients undergoing valvular heart surgery who also have high pressure, it is thought that it may reduce the risk of the right side of the heart from stopping working properly. In addition there is also evidence that it may reduce time on a ventilator in ICU. There have been several studies in heart transplants and congenital heart disease that have shown some advantage. We want to ascertain whether the theoretical advantages of the drug are actually borne out in clinical practice
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
richard.renew@waikatodhb.health.nz
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
richard.renew@waikatodhb.health.nz

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
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Documents added automatically
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