Assessment of the effectiveness of N-acetylcysteine on improving pulmonary systolic blood pressure, protein C reactive, pro- BNP, and the degree of dyspnea in patients with pulmonary hypertension and heart failure before and after treatment
effect of N-acetylcysteine before and after treatment
on CRP levels in heart failure patients
PAP levels in heart failure patients
shortness of breath and 6-minute walk test results in heart failure patients
pro-BNP levels and right ventricular function
Design
This study is a single-group trial. 32 patients from the patients of Baqee Allah Azam Hospital clinic with pulmonary hypertension based on TDI echo with sPAP≥30 and heart failure are treated with N-acetylcysteine at a dose of 600 mg every 12 hours. Patients are measured for CRP, Pro-BNP, sPAP at baseline and 3 months after treatment, and their level of dyspnea is also questioned and they must rate it from 1 to 10. The numbers are recorded and compared.
Settings and conduct
Baqiyat Allah Hospital - Lung Clinic
Participants/Inclusion and exclusion criteria
Entry requirements
1.Pulmonary arterial hypertension and heart failure
2.sPAP ≥30
Conditions of non-entry
1.Pulmonary hypertension is caused by reasons other than heart disease, such as lung disease, metabolic disease, etc.
Intervention groups
To evaluate the effectiveness of N-acetylcysteine on patients with pulmonary hypertension due to heart disease and to evaluate the level of pulmonary hypertension and C-reactive protein before and after treatment with a dose of 600 mg every 12 hours.
Main outcome variables
sPAP; CRP; Pro-BNP ;Degree of dyspnea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260224068939N1
Registration date:2026-05-20, 1405/02/30
Registration timing:retrospective
Last update:2026-05-20, 1405/02/30
Update count:0
Registration date
2026-05-20, 1405/02/30
Registrant information
Name
Shima Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8805 0435
Email address
mehrabishima808@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-02-19, 1404/11/30
Expected recruitment end date
2026-04-20, 1405/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effectiveness of N-acetylcysteine on improving pulmonary systolic blood pressure, protein C reactive, pro- BNP, and the degree of dyspnea in patients with pulmonary hypertension and heart failure before and after treatment
Public title
Studying the effect of N-acetylcysteine on PAP, CRP, Pro-BNP and symptoms caused by pulmonary hypertension in patients with heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pulmonary arterial hypertension and heart failure (heart failure patients with reduced ejection fraction, preserved left heart valve disease, cardiomyopathy, previous congenital diseases)
sPAP ≥30
Exclusion criteria:
Dissatisfaction with medication for any reason at any stage of follow-up
Pulmonary hypertension is a result of causes other than heart disease, such as lung disease, metabolic diseases, medications, infections, vascular collagen, etc.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
اEthics Committee of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences ., Southern Sheykh bahayi Street., Mollasadra Ave.,Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2026-02-15, 1404/11/26
Ethics committee reference number
IR.BMSU.BAQ.REC.1404.138
Health conditions studied
1
Description of health condition studied
Pulmonary hypertension due to heart disease
ICD-10 code
127.2
ICD-10 code description
Other secondary pulmonary hypertension
Primary outcomes
1
Description
CRP
Timepoint
At the beginning of the study and 3 months after treatment
Method of measurement
Laboratory based on milligrams per liter
2
Description
Dyspnea
Timepoint
At the beginning of the study and 3 months after treatment
Method of measurement
The patient rates their dyspnea from 1 to 10 before and after treatment.
3
Description
6-minute walk test result
Timepoint
At the beginning of the study and 3 months after treatment
Method of measurement
Based on meters
4
Description
Pulmonary artery blood pressure
Timepoint
At the beginning of the study and 3 months after treatment
Method of measurement
Based on specialized echocardiography
5
Description
pro-BNP
Timepoint
At the beginning of the study and 3 months after treatment
Method of measurement
Laboratory and unit picogram per milliliter
6
Description
Taking N-acetylcysteine
Timepoint
At the beginning of the study and 3 months after treatment
Method of measurement
Before and after consumption
7
Description
Right ventricular function
Timepoint
At the beginning of the study and 3 months after treatment
Method of measurement
Based on specialized echocardiography
8
Description
Age
Timepoint
Year
Method of measurement
Year calculation
9
Description
Gender
Timepoint
-
Method of measurement
Appearance
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Single-group clinical trial before and after treatment. 32 patients with pulmonary hypertension due to heart disease are treated with N-acetylcysteine 600 mg every 12 hours for 3 months from the Hakim brand. Before and after treatment, the criteria of shortness of breath, 6-minute test score, pulmonary hypertension score, C-reactive protein, pro-BNP, and right ventricular function are re-measured before and after 3 months of treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Shima Mehrabi
Street address
Baqiyatallah University of Medical Sciences ., Southern Sheykh bahayi Street., Mollasadra Ave.,Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Email
mehrabishima808@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Shima Mehrabi
Street address
Baqiyatallah University of Medical Sciences ., Southern Sheykh bahayi Street ., Mollasadra Ave.,Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Email
mehrabishima808@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Shima Mehrabi
Position
Lung disease fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Baqiyatallah University of Medical Sciences ., Southern Sheykh bahayi Street , Mollasadra Ave.,Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Email
mehrabishima808@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Shima Mehrabi
Position
Lung disease fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Baqiyatallah University of Medical Sciences ., Southern Sheykh bahayi Street , Mollasadra Ave.,Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Email
mehrabishima808@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Shima Mehrabi
Position
Lung disease fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Baqiyatallah University of Medical Sciences ., Southern Sheykh bahayi Street , Mollasadra Ave.,Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Email
mehrabishima808@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
All data will be available in Excel format.
When the data will become available and for how long
Start of access period 6 months after publication of results
To whom data/document is available
Researchers employed in academic and scientific institutions
Under which criteria data/document could be used
For the purpose of verification
Individuals with the qualifications mentioned in the previous section
From where data/document is obtainable
MEHRABISHIMA808@GMAIL.COM
What processes are involved for a request to access data/document
After authentication as active researchers in academic and scientific institutions