Investigating the effect of Macitentan compared to Bosentan in infants with
stable pulmonary hypertension treated with Sildenafil
Design
A clinical trial with parallel groups, double-blinded, randomized, phase 3 on 43 patients with persistent pulmonary hypertension of the newborn. The rand function of Excel software was used for randomization.
Settings and conduct
This study was conducted in the NICU of Akbarabadi Hospital. patients with persistent pulmonary hypertension of the newborn were randomly assigned to two groups. In intervention group A, neonates received Bosentan and Sildenafil. In group B, neonates received Macitentan and Sildenafil. In this study, the doctor and the researcher did not know about the type of medicine received.
Participants/Inclusion and exclusion criteria
inclusion:
1. Newborns with respiratory symptoms, decreased arterial oxygen
saturation and cyanosis
exclusion:
1. Cyanotic heart diseases
2. Increased pulmonary artery pressure due to pneumonia or meconium aspiration
Intervention groups
Group A: Bosentan tablets with a concentration of 1 mg/kg and Sildenafil with a concentration of 0.4 mg/kg every 12 hours by PG
Group B: Macitentan tablets with a concentration of 1 mg/kg and Sildenafil with a concentration of 1 mg/kg every 12 hours by PG
Main outcome variables
Response to treatment of persistent pulmonary hypertension of the newborn
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160120026115N9
Registration date:2022-12-03, 1401/09/12
Registration timing:retrospective
Last update:2022-12-03, 1401/09/12
Update count:0
Registration date
2022-12-03, 1401/09/12
Registrant information
Name
Mandana Kashaki
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 2277
Email address
kashakimd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-30, 1399/10/10
Expected recruitment end date
2021-04-23, 1400/02/03
Actual recruitment start date
2021-08-01, 1400/05/10
Actual recruitment end date
2021-11-02, 1400/08/11
Trial completion date
2022-06-02, 1401/03/12
Scientific title
The effect of Macitentan compared to Bosentan in neonates with persistent pulmonary hypertension treated with Sildenafil
Public title
The effect of Macitentan compared to Bosentan in neonates with persistent pulmonary hypertension treated with Sildenafil
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Parents' satisfaction to participate in the study
Newborns with respiratory symptoms, decreased arterial oxygen saturation, and cyanosis
Pulmonary artery pressure greater than or equal to 25 mmHg and severity of tricuspid valve failure greater than or equal to 30 mmHg with or without right-to-left shunt
Exclusion criteria:
Cyanotic heart diseases
Other diseases cyanosis
Increased pulmonary artery pressure due to pneumonia or meconium aspiration
Age
From 1 day old to 1 month old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done according to the random number table using the RAND function in Excel software. The even numbers obtained in this table were assigned to drug A (Bosentan and Sildenafil) and the odd numbers to drug B (Masitentan and Sildenafil). The random list was given to the epidemiologist of the study, and each patient who entered the study was contacted by the doctor to find out whether the person entered group A or B.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs received are identical in appearance (color and size), the pills were placed in coded envelopes with the same appearance, and the patient and cardiologist did not know about the drug received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Next to the Milad Tower, Hemat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-06-12, 1400/03/22
Ethics committee reference number
IR.IUMS.FMD.REC.1400.168
Health conditions studied
1
Description of health condition studied
Persistent pulmonary hypertension of the newborn
ICD-10 code
P29.3
ICD-10 code description
Persistent fetal circulation
Primary outcomes
1
Description
Persistent Pulmonary Hypertension of the Newborn
Timepoint
The beginning of the study, 6 and 12 days after the intervention
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Bosentan tablets (manufactured by Faran Shimi, Iran) with a concentration of 1 mg/kg and Sildenafil (Alborz Darou) with a concentration of 0.4 mg /kg every 12 hours were prescribed. The treatment was discontinued when the arterial oxygen saturation level was higher than 95 and the Pulmonary Arterial Hypertension was lower than 25 in echocardiography and the severity of Tricuspid valve regurgitation was lower than 30.
Category
Treatment - Drugs
2
Description
Intervention group: Macitentan tablets (Tadbir Kalaye Jam) with a concentration of 1 mg/kg and Sildenafil(Alborz Darou) with a concentration of 1 mg/kg every twelve hours were prescribed. The treatment was discontinued when the arterial oxygen saturation level was higher than 95 and the Pulmonary Arterial Hypertension was lower than 25 in echocardiography and the severity of Tricuspid valve regurgitation was lower than 30.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbarabadi Hospital
Full name of responsible person
Sama dabbagh
Street address
Molavi St, Molavi (cross)
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 917 411 8132
Fax
+98 21 5560 8012
Email
S.dabbagh69@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Keyvani
Street address
Next to the Milad tower, Shahid Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sama dabbagh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Next to the Milad Tower, Hemat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8843 0783
Email
S.dabbagh69@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mandana Kashaki
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Molavi (cross), Molavi St
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
kashakimd@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sama dabbagh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No193, Zafar St, Aliasghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 8843 0783
Email
S.dabbagh69@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Avalable Information
When the data will become available and for how long
1402
To whom data/document is available
All of peaple
Under which criteria data/document could be used
Information
From where data/document is obtainable
Email
S.dabbagh69@yahoo.com
What processes are involved for a request to access data/document