| CTRI Number |
CTRI/2024/04/066392 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of valsartan-sacubitril on cardiometabolic peptides |
|
Scientific Title of Study
|
Therapeutic outcomes of modulation of cardiometabolic peptides by Angiotensin Receptor-Neprilysin Inhibitor in patients of Heart Failure- A prospective observational study |
| Trial Acronym |
ARNI-ENDO-CHF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Upinder Kaur |
| Designation |
Assistant Professor |
| Affiliation |
IMS-BHU |
| Address |
Dept. of Pharmacology, IMS-BHU, Varanasi-UP
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9935615546 |
| Fax |
|
| Email |
drupinder.bhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Upinder Kaur |
| Designation |
Assistant Professor |
| Affiliation |
IMS BHU |
| Address |
Dept. of Pharmacology, IMS-BHU, Varanasi-UP
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9935615546 |
| Fax |
|
| Email |
drupinder.bhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Upinder Kaur |
| Designation |
Assistant Professor |
| Affiliation |
IMS BHU |
| Address |
Dept of Pharmacology, IMS BHU, Varanasi UP
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9935615546 |
| Fax |
|
| Email |
drupinder.bhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute OF Medical Sciences BHU |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Upinder Kaur and Dr Umesh Pandey |
Institute of Medical Sciences, BHU, Varanasi, UP |
Department of Cardiology, CSSB
Varanasi
UTTAR PRADESH |
9935615546
drupinder.bhu@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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: I502||Systolic (congestive) heart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Valsartan-Sacubitril (already approved by DCGI for heart failure) |
By oral route at 50 mg BD to 100 mg BD dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of 18 years of age and above and individuals of both genders diagnosed with heart failure (NYHA class II-IV) with ejection fraction less than 40 % irrespective of the etiology of heart failure and who give consent for participation in the study, shall be the study participants. |
|
| ExclusionCriteria |
| Details |
Patients of heart failure with a recent history of serious cardiovascular event such as myocardial infarction, stroke, or other thromboembolic event in last one month
2. Patients of heart failure with sepsis
3. Patients of heart failure with EF ≥ 40%
4. Patients who refuse to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the serum levels of endothelin-1, neuropeptide Y, and bradykinins |
at baseline, 4 weeks, 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Improvement in 2-D Echo markers like
Left ventricle ejection fraction (LVEF), left ventricle end diastolic volume index (LVEDVI), left ventricle end systolic volume index (LVESVI), at 1-month, 6 month and 12 month compared to baseline.
• Levels of BNP and NT-Pro BNP at baseline, 1 month and 6 month
• Hospitalisations due to heart failure and time to hospitalisation due to heart failure since the onset of therapy over 18 months of follow up.
• Death due to cardiovascular cause and time to occurrence of death since the onset of therapy over 18 months of follow up.
• Death due to any cause and time to occurrence of death since the onset of therapy over 18 months of follow up.
|
0, 1 month, 6 month, 12 month, 18 month |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
10/05/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
A novel class of angiotensin receptor-neprilysin inhibitor (ARNI) has been approved as a potential therapeutic avenue in patients of heart failure with reduced ejection fraction (HFrEF). While the inhibition of neprilysin and resulting elevation of natriuretic peptides is believed to exert cardioprotective effects, elevated levels of other neprilysin substrates such as endothelin-1, bradykinin, and neuropeptide Y is expected to cause deleterious effects such as cardiac fibrosis, pulmonary hypertension, impaired glucose tolerance and angioedema. The objectives of the present study are: • Primary: To assess the association between change in endothelin-1 levels and cardio-metabolic outcomes* in patients of HFrEF on valsartan-sacubitril compared to standard care of therapy • Secondary: • To analyse association between change in neuropeptide Y (NPY) levels and cardiometabolic outcomes* in patients of HFrEF on valsartan-sacubitril compared to standard care of therapy. • To measure association between change in bradykinin levels and cardiometabolic outcomes* in patients of HFrEF on valsartan-sacubitril compared to standard care of therapy . To assess adverse events in patients of HFrEF on valsartan-sacubitril and standard care of therapy
*To specify, cardiometabolic outcomes include 2-D echo markers such as left ventricular ejection fraction (LVEF), biochemical markers such as brain natriuretic peptide (BNP)and NT-pro BNP levels and metabolic parameters such as blood glucose and body weight |