FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093843 [Registered on: 28/08/2025] Trial Registered Prospectively
Last Modified On: 27/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical trial for comparing the effectiveness of nebulized nitroglycerin in patients with right heart failure with severe pulmonary artery hypertension vs placebo with nebulized normal saline. 
Scientific Title of Study   Effectiveness of nebulized nitroglycerine in patients with right heart failure with severe pulmonary artery hypertension - A prospective,randomized, placebo controlled trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr.Bala Ajay pavan Kumar reddy Kasu  
Designation  Postgraduate student  
Affiliation  Nizams institute of medical sciences  
Address  Nims emergency block , ground floor Nizams institute of medical sciences Paniagutta Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  9963171512  
Fax    
Email  Kasu.ajayreddy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Ashima Sharma  
Designation  Senior professor  
Affiliation  Nizams institute of medical sciences  
Address  Nims emergency block , first floor Nizams institute of medical sciences Panjagutta

Hyderabad
TELANGANA
500082
India 
Phone  9848248663  
Fax    
Email  ashimanims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.Bala Ajay pavan Kumar reddy Kasu  
Designation  Postgraduate student  
Affiliation  Nizams institute of medical sciences  
Address  Nims emergency block , ground floor Nizams institute of medical sciences Panjagutta

Hyderabad
TELANGANA
500082
India 
Phone  9963171512  
Fax    
Email  Kasu.ajayreddy@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  DrBala Ajay pavan Kumar reddy Kasu  
Address  Nims emergency block , ground floor Nizams institute of medical sciences Panjagutta Hyderabad Telangana 500082 
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrBala ajay pavan Kumar reddy Kasu  Nizams institute of medical sciences   Nims emergency block , ground floor Nizams institute of medical sciences Panjagutta Hyderabad 500082
Hyderabad
TELANGANA 		 9963171512

Kasu.ajayreddy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS Institutional Ethics Committee (NIEC), Hyderabad, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I279||Pulmonary heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nebulised normal saline as placebo for shortness of breath secondary to right heart failure  The intervention group will receive nebulized nitroglycerin administered via a standard nebulizer device, with a starting dose of 5mg every 30 mins titrated based on hemodynamic response and tolerance. The control group will receive nebulized normal saline at the same frequency and volume. All participants will continue to receive standard therapy for right heart failure, including diuretics, vasopressors, non invasive ventilation and supportive measures. Vitals will be recorded before and after each nebulization. total number of nebulizations will be three, each given at a 30 minutes interval. 
Intervention  Use of nebulised nitroglycerin in patients presenting with shortness of breath secondary to right heart failure   The intervention group will receive nebulized nitroglycerin administered via a standard nebulizer device, with a starting dose of 5mg every 30 mins titrated based on hemodynamic response and tolerance. The control group will receive nebulized normal saline at the same frequency and volume. All participants will continue to receive standard therapy for right heart failure, including diuretics, vasopressors, non invasive ventilation and supportive measures. Vitals will be recorded before and after each nebulization. total number of nebulizations will be three, each given at a 30 minutes interval.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Male 
Details  1. Patients who are confirmed cases of right heart failure secondary to severe PAH presenting to emergency department with severe SOB.
2. Patients who have provided with written consent after explaining the intervention
3. Patients with SBP above 100 mmHg. 
 
ExclusionCriteria 
Details  1.known allergies to nitroglycerin
2.hypotension , left heart failure , severe ms
3.ACS , ARDS , severe COPD
4.pregnancy /lactation
5. Inability to provide consent
6 .known methemaoglobinemia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness and safety of nebulized nitroglycerine as an adjunctive therapy for managing shortness of breath secondary to severe PAH in right heart failure patients by measuring improvement in dyspnea score..
 		 Outcomes are measured at baseline after giving 3rd dose of nebulization , after 1 and half hour  
 
Secondary Outcome  
Outcome  TimePoints 
To compare vitals , blood gases , lactates , shock index
To compare time on ventilator
Mortality
To compare echo findings  		 All the Outcomes except time on ventilator & mortality are measured at baseline after 3rd dose of nebulisation after 1 & half hour
Time on ventilator & mortality is measured at discharge - with in 4 weeks  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/09/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is how i enroll participants ??

Eligible participants will include adult patients (aged 18 years and older) presenting with acute onset of Shortness of breath (SOB) in a confirmed case of  right heart failure(RHF ) with severe PAH ( pulmonary artery hypertension ) will be recruited to the study. The patient will be started on O2 by a non rebreathing mask at 10-15 liters per minute. ECG will be taken to rule out acute MI as the cause of SOB. History of fever, cough with sputum will be recorded and chest will be auscultated crepitations. Bedside chest radiograph will be ordered to rule out pneumonia. Arterial blood gas sample will be obtained simultaneously and results recorded . PaO2 -FiO2 ratio will be documented to rule out ARDS. Cardiologist on call will be requested for POCUS to assess cardiac function.Following findings on POCUS suggest RHF- Right ventricle dilatation, Tricuspid regurgitation, Right ventricular free wall diastolic collapse, Mcconnels sign,abnormal TAPSE values and dilated IVC and pulmonary artery hypertension is measured by systolic pulmonary artery pressure in which 

mPAP > 55mm hg indicates severe PAH .Patients included in the study will be explained about the study process and written consent will be taken. Exclusion criteria have contraindication to nitroglycerin therapy, such as allergy, recent use of phosphodiesterase inhibitors, and significant hypovolemia ( IVC diameter less than 1 cm and completely collapsing on deep inspiration).

 


 


 
Close