A clinical trial to assess efficacy of Angiotensin Receptor Nephrilysin Inhibitor (Sacubitril/Valsartan) in right ventricular systolic dysfunction with normal LV functionâ€

Phase 2/3

Not yet recruiting

Conditions: Other secondary pulmonary hypertension,

Registration Number: CTRI/2023/01/049280

Lead Sponsor: MDM hospitalDr SN Medical College

Brief Summary: ARNI is approved for heart failure with reduced ejection fraction.so our study will be aiming to assess efficacy of ARNI in RV systolic dysfunction with normal LV function.so patients will be enrolled and randomized in 2 groups by block randomization and will be assessed at baseline ,1 month, 3 month by blood and echo parameters.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patients of Right Ventricular systolic dysfunction with Normal Left ventricular systolic function as diagnosed by transthoracic echocardiography parameters such as TAPSE(<16mm), PAsP(>25mm Hg), tricuspid annular velocity(<10 cm/sec), Fractional area change(<35%) and blood markers such as NT-proBNp(>400pg/ml).

Exclusion Criteria

1.Patients with LVEF <50% 2.Pregnancy 3.
Severe hepatic impairment (Child.
Pugh C) 4.Severe renal imapairment (eGFR<30 ml/min/1.73m2) â€¢Hypersensitivity to any component of the product â€¢A prior history of angioedema due to an ACEI or ARB.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in clinical ie NYHA class and echo parameter ie TAPSE,PASP,RV S,FAC.	First at baseline,1 month, then at 3 month

Secondary Outcome Measures

Name	Time	Method
CV death, Hypotension, total HF hospitalization.	CV death, Hypotension, total HF hospitalization over 3 months

Trial Locations

Locations (1): Mdm hospital
🇮🇳
Jodhpur, RAJASTHAN, India
Mdm hospital
🇮🇳Jodhpur, RAJASTHAN, India
Dr Viplov Kesarwani
Principal investigator
9416158008
viplovkesarwani@gmail.com