| CTRI Number |
CTRI/2025/10/096455 [Registered on: 24/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Measurement of change in eGFR levels with primary drugs used in heart failure with chronic kidney disease |
|
Scientific Title of Study
|
Prospective evaluation of eGFR changes during therapy optimization in heart failure patients with chronic kidney disease |
| Trial Acronym |
NO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shoban Babu Varthya |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences, Jodhpur |
| Address |
Department Of Pharmacology, All India Institute Of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8437726777 |
| Fax |
|
| Email |
drshobanpgimer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shoban Babu Varthya |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences, Jodhpur |
| Address |
Department Of Pharmacology, All India Institute Of Medical Sciences, Jodhpur
RAJASTHAN
342005
India |
| Phone |
8437726777 |
| Fax |
|
| Email |
drshobanpgimer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharmin Maheshbhai Patel |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences, Jodhpur |
| Address |
Department Of Pharmacology, All India Institute Of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9712529521 |
| Fax |
|
| Email |
dharminpatel16897@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences Jodhpur |
| Address |
All India Institute Of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Type of Sponsor |
Government medical college |
|
|
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 Shoban Babu Varthya |
AIIMS, JODHPUR |
Department Of Cardiology, Nephrology, Biochemistry, Pharmacology, All India Institute Of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN |
8437726777
drshobanpgimer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: I501||Left ventricular failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age 18 year to 80 year and of either sex.
2. Patients of Heart failure with reduced ejection fraction.
3. Patients with eGFR less than 90 ml per min per 1.73 m2 at screening. |
|
| ExclusionCriteria |
| Details |
1. Patients who are already on any of the first-line heart failure drugs for other
indications.
2. Patients with preserved ejection fraction.
3. Patients with raised AST/ALT more than 3 times from baseline.
4. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in eGFR levels from baseline to 16 weeks. |
baseline, 16 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean change in eGFR levels from baseline to 16 weeks based on type of
therapeutic intervention.
2. Mean change in eGFR levels from baseline to 16 weeks based on chronic kidney
disease (CKD) stages.
3. Corelation between mean change in eGFR with NT-pro BNP and GDF-15 levels
from baseline to 16 weeks among HFrEF and CKD patients having diabetes.
4. Cost effectiveness analysis of first line drug therapy used in HErEF with CKD
patients over 16 weeks.
5. Safety profile of first line drug therapy used in HErEF with CKD patients over
16 weeks.
6. Change in Health status from baseline to 16 weeks based on KCCQ-OSS Score. |
baseline, 16th week |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
04/11/2025 |
| 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="7"
Days="25" |
|
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
|
Background
Heart failure is a chronic disease where heart’s ability to pump the blood adequately to periphery is reduced which usually results in symptoms like breathlessness, swelling in the legs, ankles, and feet, fatigue and weakness, rapid or irregular heartbeat, light-headedness etc. CKD is common in patients with HF and is associated with high morbidity and mortality. This study compares the effectiveness and safety analysis of first line drug therapies used in HErEF and CKD patients.
Materials and Methods
The study is designed as single centre, Prospective observational study. Participants meeting the eligibility criteria will be recruited from the Cardiology OPD of AIIMS Jodhpur. The study will involve recording of eGFR, NT-pro-BNP, GDF-15, KCCQ OS, ECHO findings in these patients. Subsequently, the safety and effectiveness of all first line drugs used in HErEF and CKD will be evaluated. The outcomes of the study will be determined based on the assessment at the 16th week.
Implications
According to the guidelines set forth by AHA, the initial pharmacological approach for managing HFrEF includes the utilization of beta blockers, Angiotensin converting enzyme (ACE) inhibitors, Angiotensin receptor blockers (ARBs), Angiotensin receptor neprilysin inhibitors (ARNIs), Mineralocorticoid receptor antagonists (MRA), and SGLT2 inhibitors. However there are challenges to the implementation of these medications in patients with concomitant CKD due to increased vulnerability to common side effects (worsening renal function, hyperkalaemia, hypotension). Therefore this study is planned for understanding the relative safer regime among the first line therapies for HErEF in patients with concomitant CKD. |