| CTRI Number |
CTRI/2024/05/067547 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Pulmonary Hypertension and Chronic Kidney disease |
|
Scientific Title of Study
|
Prevalence of Pulmonary Hypertension in patients of Chronic Kidney Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikhil Pantbalekundri |
| Designation |
PG student |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi- Meghe |
| Address |
Department of General Medicine, 3rd floor, Acharya Vinobha Bhave Rural Medical College, Sawangi- Meghe.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9833595850 |
| Fax |
|
| Email |
nikhil6996pant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Satish Mahajan |
| Designation |
Professor |
| Affiliation |
Department of Medicine, Jawaharlal Nehru Medical College, Sawangi- Meghe |
| Address |
Department of General Medicine,
Acharya Vinobha Bhave Rural Medical College, Sawangi-Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9833595850 |
| Fax |
|
| Email |
mahajandr99@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikhil Pantbalekundri |
| Designation |
PG student |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi- Meghe |
| Address |
At-Post Akol, Tal- Chikodi, Dist- Belgavi, Karnataka
Belgaum
KARNATAKA
591211
India |
| Phone |
9833595850 |
| Fax |
|
| Email |
nikhil6996pant@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Medicine,3rd floor, Acharya Vinobha Bhave Rural Medical College, Sawangi-Meghe, Wardha, Maharashtra- 442001 |
|
|
Primary Sponsor
|
| Name |
Nikhil Pantbalekundri |
| Address |
Department of General Medicine, Jawaharlal Nehru Medical College, Sawangi- Meghe |
| 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 Nikhil Pantbalekundri |
Acharya Vinobha Bhava Rural Hospital |
Department of Medicine,3rd floor, Acharya Vinobha Bhave Rural Medical College, Sawangi-Meghe, Wardha, Maharashtra- 442001
Wardha
MAHARASHTRA |
9833595850
nikhil6996pant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, (2) ICD-10 Condition: N186||End stage renal disease, (3) ICD-10 Condition: N185||Chronic kidney disease, stage 5, (4) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (5) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), (6) ICD-10 Condition: N182||Chronic kidney disease, stage 2 (mild), (7) ICD-10 Condition: N181||Chronic kidney disease, stage 1, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Newly Diagnosed CKD cases
2) Known cases of CKD on Conservative treatment
3) Known case of CKD on maintenance hemodialysis
4) Patients giving consent |
|
| ExclusionCriteria |
| Details |
1) Not willing to Participate
2) Age less than 18years
3) Valvular heart disease
4) Congenital heart Disease
5) Pulmonary obstructive and restrictive diseases
6) HIV infected patients
7) Chronic liver disease
8) Connective tissue diseases
9) Hypothyroidism and Hyperthyroidism |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Statistically significant (p0.05) Prevalence of Pulmonary artery hypertension in patients of Chronic kidney disease (PASP 35 mmHg)
2) Prevalence is higher with higher grades of chronic kidney disease
2) Pulmonary artery hypertension can be used as an indicator for poor prognosis in end stage renal disease |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| strong association between diabetes & hypertension with PH (p less than 0.001) |
8 days after admission |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2024 |
| 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="2"
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
|
The history will be collected with special attention to CKD symptoms, congestive heart failure, PH, risk factors for developing CKD, concomitant diseases, and the length of time from CKD diagnosis. CKD, heart failure, and PH clinical symptoms were evaluated. Each case will be investigated thoroughly. The Modification of Diet in Renal Disease formula will be used to measure the estimated glomerular filtration rate (eGFR). An electrocardiogram (ECG) will be performed to search for signs of PH, right ventricular (RV) strain pattern, left ventricular (LV) strain pattern, and ischemic heart disease (IHD). The pulmonary artery systolic pressure (PASP) will be computed using the Bernoulli equation and TR jet velocity in Doppler echocardiography. At rest, a PASP value of 35 mmHg is being considered suggestive of PH. Echocardiography will also used to assess the LV hypertrophy, dilatation, chamber size, LV systolic function and diastolic function, LV ejection fraction (EF), regional wall motion abnormality, and pericardial effusion. Comparison will be made between CKD patients with presence and absence of PH. |