| CTRI Number |
CTRI/2024/06/069470 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the beneficial effect and safety of tadalafil compared to sildenafil in pulmonary hypertensive patients due to lung disease |
|
Scientific Title of Study
|
Effectiveness and safety of tadalafil in comparison with sildenafil in the group -3
pulmonary hypertension patients: A randomized, open label, parallel group study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Midhun Sakravarthy J |
| Designation |
Junior Resident |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Pharmacology, 4th floor, Academic Block, ESIC
Medical college and Hospital, Sanathnagar
Hyderabad
TELANGANA
500038
India |
| Phone |
8220473742 |
| Fax |
|
| Email |
dr.midhunsakravarthy916@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Surendar Reddy |
| Designation |
Professor and Head of the Department Pulmonology |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Pulmonology, 6th floor, Hospital Building, ESIC Medical college and Hospital, Sanathnagar
Hyderabad
TELANGANA
500038
India |
| Phone |
9700565999 |
| Fax |
|
| Email |
surendark918@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mehdi Ali Mirza |
| Designation |
Assistant Professor Pharmacology |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Pharmacology, 4th floor, Academic Block, ESIC
Medical college and Hospital, Sanathnagar
Hyderabad
TELANGANA
500038
India |
| Phone |
9160368850 |
| Fax |
|
| Email |
mehdialimirza@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital, 7-1-634, National Highway 65, Sanjeeva Reddy Nagar, Sanathnagar, Hyderabad, Telangana, India - 500038 |
|
|
Primary Sponsor
|
| Name |
Midhun Sakravarthy J |
| Address |
Department of Pharmacology, 4th floor, Academic Block, ESIC Medical college and Hospital, Sanathnagar, Hyderabad, Telangana, India - 500038 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Midhun Sakravarthy J |
ESIC Medical College and Hospital |
Department of
Pulmonology, 4th
floor, OPD building,
ESIC Medical College
and Hospital, Sanathnagar
Hyderabad
TELANGANA |
8220473742
dr.midhunsakravarthy916@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, ESIC Medical College & Hospital and ESIC Super Specialty Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I272||Other secondary pulmonary hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SILDENAFIL |
SILDENAFIL 20mg three times a day for 6 months |
| Intervention |
TADALAFIL |
TADALAFIL 40mg once a day for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender
2. Aged more than 18 years
3. Patients who are diagnosed with Pulmonary Hypertension based on 2D-Echo having
any pulmonary etiology (Group 3) not on any pulmonary vasodilator therapy and
WHO Functional Class II-III |
|
| ExclusionCriteria |
| Details |
1. Impaired hepatic Function with elevated AST or ALT levels ≥ 3 times the upper limit
of normal
2. Patient with history of renal disease or impaired kidney function with elevated Serum
creatinine
3. Pregnant and lactating women
4. Patients requiring nitrate therapy for any clinical indication.
5. Contraindication to Tadalafil or Sildenafil use including allergy to any PDE-5
inhibitor, anatomical deformations of the penis, sickle cell anemia, multiple
myeloma, leukemia, bleeding disorders, active peptic ulcer disease, retinitis
pigmentosa or other retinal disorders
6. The use or anticipated use of any of the following drugs: any nitrate, protease
inhibitor, anti-fungal agent and/or rifampin, or doxazosin.
7. Known malignancies
8. Known other heart related co-morbid |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in 2D-Echo parameters (RVSP, TRJET)
2. Change in Six-Minute Walk distance Test |
1.0,3rd and 6th month
2.0,3rd and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Arterial Blood Gas(PaO2)
2.Change in WHO-Functional class for pulmonary hypertensive patients
3.Adverse reactions |
1.0,3rd and 6th month
2.0,3rd and 6th month
3.0,3rd and 6th month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Pulmonary hypertension is defined as a mean Pulmonary Artery Pressure greater than 20 mmHg at rest, measured by right heart catheterization. It is clinically classified into 5 groups. Those are 1) Pulmonary Arterial Hypertension; 2) Pulmonary Hypertension due to Left Heart Disease; (3) Pulmonary Hypertension caused by lung disease and/or hypoxia (PH-LD); 4) chronic thromboembolic Pulmonary Hypertension (CTEPH); and 5) Pulmonary Hypertension with unclear and/or multifactorial mechanisms. It is classified functionally by World Health Organization (WHO-FC) into 4 class which can be used for the assessment of severity. The recent global prevalence of it is estimated to be around 1% which increases up to 10% in individuals over 65 years. The incidence of PAH varies among countries. It depends on risk factors like air pollution, cigarette smoking and others like various lung diseases. The right heart catheterization, an invasive gold standard technique and the doppler echocardiography, a non-invasive test is available for diagnosis. Other supporting investigations comprise of Chest X-Ray, ECG and CT angiography, this aids in differential diagnosis. Pulmonary Function Test (PFT) and 6-minute walk test are the markers in the assessment of the severity of the lung disease and exercise capacity respectively. Oxygen supplementation is the main therapy that relieves hypoxemic pulmonary vasoconstriction. This leads to improved cardiac output, lessens sympathetic vasoconstriction, alleviates tissue hypoxemia, and improves renal perfusion. The Pharmacological treatment includes Pulmonary Arterial Hypertension (PAH) directed therapy like prostacyclin analogs (Teprostinil, Epoprostenol), endothelin receptor blockers (Bosentan, Ambrisentan), Phosphodiesterase-5 (PDE-5) inhibitors (Sildenafil, Tadalafil). This PAH-directed therapy is approved for the group-1 Pulmonary Hypertension patients where the primary etiology is in the pulmonary vasculature. However, in the clinical practice many centres prescribe Sildenafil or Tadalafil in the Group-3 PH like COPD associated Pulmonary Hypertension patients. Treatment with pulmonary vasodilators remains controversial in the group 3 PH patients as some studies has shown benefits and some studies has shown adverse events like deterioration of oxygenation due to the inhibition of hypoxic pulmonary vasoconstriction leads to impaired gas exchange and it has shown no significant improvement in the Six-minute walk distance test and WHO-FC. The present study is planned to determine the effectiveness and safety of Tadalafil in comparison with the Sildenafil in the group 3 PH patients. |