Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201703002106114 Date of Approval: 15/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of preoperative sildenafil on operative and early postoperative outcome after mitral valve replacement in patients with pulmonary hypertens
Official scientific title The effect of preoperative adminstration of sildenafil on operative and early postoperative outcome after mitral valve replacement in patients with severe pulmonary hypertension
Brief summary describing the background and objectives of the trial Mitral valve disease with pulmonary hypertension is characterized by a progressive increase in pulmonary vascular resistance leading to right ventricular failure and mortality. Prognosis of patients with severe pulmonary hypertension is poor, and treatment options are limited. Pulmonary hypertension (PH) is a condition defined as an increase of the mean pulmonary artery pressure more than 25 mm Hg at rest as assessed by right-heart catheterization. The mechanisms leading to pulmonary hypertension in mitral stenosis are retrograde transmission of left heart pressures to the pulmonary venous and arterial beds (passive component), which triggers an increased vascular tone (vasoconstriction) in the pulmonary arterial bed (reactive component), and a subsequent pulmonary vascular remodeling, leading to irreversible pulmonary vascular disease.Several therapies are prescribed for patients with pulmonary hypertension. Conventional treatments include: calcium-channel blockers, anti-coagulants, diuretics and oxygen. For more advanced cases, disease-specific classes of drugs currently registered on the market include: prostanoids, selective and non-selective endothelin antagonists and phosphodiesterase-5 inhibitors. sildenafil belongs to a class of drugs called phosphodiesterase (PDE) inhibitors. Oral sildenafil is a phosphodiesterase type 5 (PDE5) inhibitor which increases cyclic guanosine monophosphate (cGMP)levels and has been shown to be effective for primary pulmonary hypertension. It has been shown that sildenafil can be used to manage secondary pulmonary hypertension in perioperative period in patients undergoing cardiac surgeries. Several studies have documented a relaxant effect of sildenafil on the pulmonary vascular smooth muscle with lowering of the pulmonary artery pressure and pulmonary vascular resistance in patients with various forms of pulmonary hypertension
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,pulmonary hypertension, cardiac surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/04/2017
Actual trial start date 02/04/2017
Anticipated date of last follow up 15/03/2018
Actual Last follow-up date 29/03/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group A Sildenafil 20 mg three times daily 7 days (one week) preoperative Including 20 patients with pulmonary hypertension (pulmonary artery systolic pressure ¿50mmHg) who will take oral sildenafil20 mg three times daily one week before surgery 20
Experimental Group group B Sildenafil 20 mg three times daily 28 days (four weeks) preoperative Including 20 patients with pulmonary hypertension (pulmonary artery systolic pressure ¿50mmHg) who will take oral sildenafil 20 mg three times daily four weeks before surgery 20
Control Group group C none none Including 20 patients with pulmonary hypertension (pulmonary artery systolic pressure ¿50mmHg) who won¿t take sildenafil 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients who will be scheduled for elective mitral valve replacement surgery with pulmonary hypertension (pulmonary artery systolic pressure(PASP) ¿50mmHg) Co-existing coronary artery diseases. Emergency mitral valve replacement. Redo mitral valve replacement. Congestive heart failure. Renal dysfunction, creatinine > 2 mg / dl. Hepatic dysfunction, bilirubin > 3 mg /dl. Chronic obstructive pulmonary disease, FEV1/FEVC< 7. Concomitant aortic valve replacement. Severe tricuspid regurgitation. 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/03/2017 Faculty of Medicine, Menoufia University
Ethics Committee Address
Street address City Postal code Country
Gamal abdel nasser street Shebin El-Kom - Menoufia Governerate 23154 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome effect of oral Sildenafil on lowering pulmonary hypertension preoperative Pulmonary artery systolic pressure will be measured in all groups four weeks and 24 hours before surgery and 24 hours after surgery and one month post discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University - Faculty of Medicine University hospitals Gamal abdel nasser street Shebin El-Kom- Menoufia governerate 23154 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine, Menoufia University Gamal abdel nasser street Shebin El-Kom- Menoufia governerate 23154 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cardiothoracic surgery department - Faculty of Medicine - Menoufia University Gamal abdel nasser street Shebin El-Kom- Menoufia governerate 23154 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Labib Dokhan Gamal abdel nasser street Shebin El-Kom- Menoufia governerate 23154 Egypt
Islam Moheb Ibrahim Gamal abdel nasser street Shebin El-Kom- Menoufia governerate 23154 Egypt
Mohammed Gouda Abdellatif Gamal abdel nasser street Shebin El-Kom- Menoufia governerate 23154 Egypt
Rasha Elsebaey Soliman Gamal abdel nasser street Shebin El-Kom- Menoufia governerate 23154 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Gouda Abdellatif drgouda710@yahoo.com 0201004256442 Gamal abdel nasser street
City Postal code Country Position/Affiliation
Shebin El-Kom - Menoufia 23154 Egypt Lecturer of cardiothoracic surgery, Faculty of Medicine, Menoufia University
Role Name Email Phone Street address
Public Enquiries Rasha Elsebaey Soliman rashacts@gmail.com 0201015405423 Gamal abdel nasser street
City Postal code Country Position/Affiliation
Shebin El-Kom - Menoufia 23154 Egypt assisstant lecturer of cardiothoracic surgery, Faculty of Medicine, Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Mohammed Gouda Abdellatif drgouda710@yahoo.com 0201004256442 Gamal abdel nasser street
City Postal code Country Position/Affiliation
Shebin El-Kom - Menoufia 23154 Egypt Lecturer of cardiothoracic surgery, Faculty of Medicine, Menoufia University
REPORTING
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