| CTRI Number |
CTRI/2024/02/063203 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and efficacy of sacubitril/valsartan in patients with congenital heart diease with systemic right ventricular dysfunction – a prospective observational study |
|
Scientific Title of Study
|
Safety and efficacy of sacubitril/valsartan for systemic right ventricular dysfunction – a prospective observational 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 |
Dr Punitha Lakxmi Ramesh |
| Designation |
DM Cardiology |
| Affiliation |
Sree Chitra Tirunal Institute For Medical Science And Technology |
| Address |
Sree Chitra Tirunal Institute For Medical Science And Technology
No2 13th main 4th cross HAL 3rd stag Kodihalli Bengaluru 560008
Karnataka
Thiruvananthapuram
KERALA
695011
India |
| Phone |
07892950256 |
| Fax |
|
| Email |
punitha.lakxmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.K.M.Krishnamoorthy |
| Designation |
Professor |
| Affiliation |
Sree Chitra Tirunal Institute For Medical Science And Technology |
| Address |
Sree Chitra Tirunal Institute For Medical Science And Technology
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447239424 |
| Fax |
|
| Email |
kmkm@sctimst.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Punitha Lakxmi Ramesh |
| Designation |
DM Cardiology |
| Affiliation |
Sree Chitra Tirunal Institute For Medical Science And Technology |
| Address |
Sree Chitra Tirunal Institute For Medical Science And Technology
No2 13th main 4th cross HAL 3rd stag Kodihalli Bengaluru 560008
Karnataka
Thiruvananthapuram
KERALA
695011
India |
| Phone |
07892950256 |
| Fax |
|
| Email |
punitha.lakxmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pediatric Cardiac Society of India, Room No 29,Department of Cardiology, AIIMS, New Delhi -110029 |
|
|
Primary Sponsor
|
| Name |
Pediatric Cardiac Society of India |
| Address |
Room No 29,Department of Cardiology, AIIMS, New Delhi -110029 |
| 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 Punitha Lakxmi Ramesh |
Sree Chitra Tirunal Institute For Medical Science And Technology |
Room No 1211
Department of Cardiology
Medical college PO
Thiruvananthapuram
695011
Thiruvananthapuram
KERALA |
7892950256
punitha.lakxmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES AND TECHNOLOGY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I508||Other heart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
After obtaining written informed consent, all consecutive patients with systemic right ventricular dysfunction,
ie, systemic right ventricular ejection fraction (sRV EF) ≤40% or fractional area change (FAC) ≤35%, assessed
by ECHO would be included. |
|
| ExclusionCriteria |
| Details |
1. Univentricular physiology
2. Systolic blood pressure < 90mmHg or <5th centile for age and height (whichever is lower)
3. GFR < 30ml/min/1.73m2
4. Serum potassium > 5.5 mEq/L
5. Previous intolerance to ACEi/ARB/ARNI |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of patients achieving systemic right ventricular ejection fraction > 40% or fractional area change >35%
|
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety of sacubitril/valsartan as assessed by blood pressure, renal function test, serum electrolytes
|
18 MONTHS |
Proportion of patients achieving the target dose of sacubitril/valsartan at 3months and 12months
|
3 months and 12 months |
| Improvement in NYHA/Ross functional class |
18 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
11/03/2024 |
| 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
|
It is a prospective interventional study to analyse the safety and efficacy of sacubitril/valsartan in patients
with systemic right ventricular dysfunction, over a therapy period of 18 months. All patients, meeting the inclusion criteria, will be recruited by the principal investigator, from the cardiology
outpatient department. Patients on irregular follow up would be traced from the EMR and contacted. The
investigating cardiologist will educate the patient regarding the proposed study. A consent form, written
either in English or in Malayalam language, will be signed by the patient and witness of the patient (as per the
SCTIMST norms). Patients who have died subsequently would be identified by records maintained in the
Medical Records Department with the help of the medical social worker in the department.Treatment naïve patients would be initiated
on sacubitril/valsartan at a dose of 24/26mg (1.6mg/kg/dose) twice daily. Those patients receiving 80mg of
valsartan twice daily or an equivalent dose of other ACEi/ARB, would be started on sacubitril/ valsartan
49/51mg twice daily. If the dose of ACEi/ARB is less than valsartan 80mg twice daily or an equivalent dose
of other ACEi/ARB, sacubitril/valsartan 24/26mg twice daily would be initiated. In children, receiving
enalapril 0.1 mg/kg/dose or 0.2 mg/kg/dose would be initiated on sacubitril/valsartan 1.6 mg/kg/dose or 3.1
mg/kg/dose, respectively (maximum 200mg twice daily irrespective of body weight). Sacubitril/valsartan
would be initiated after discontinuing ACEi/ARB for 36 hours.
If the medication is well tolerated, sacubitril/ valsartan would be increased in a stepwise fashion until the
highest tolerated dose (200mg twice daily or 3.1mg/kg/dose twice daily, whichever is lower) is reached. If
systolic blood pressure < 90mmHg or <5th centile for age and height (whichever is lower), potassium
>5.5mmol/L and/or eGFR <30ml/min/1.73m2
, dose would be reduced and followed-up after 2–4 weeks.
Patient would be followed up at 1, 3, 6, 12, 18 months. NYHA functional class, vitals, physical examination,
ECHO (2D and strain imaging), 6minute walk test, would be performed by principal investigator at baseline
and each visit there after. Renal function test, serum electrolytes and NT-pro BNP test will be performed as
per department protocol on follow up of heart failure patients on ACEi/ARB/ARNI. No additional invasive
investigations are being planned as part of the study.
|