Skip to content

To study the effect of the drug Sacubutril-Valsartan on diastolic function in heart failure patients

To study the effect of Sacubutril-Valsartan on the diastolic function of the heart in patients with heart failure with reduced ejection fraction

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/04/024445
Enrollment
48
Registered
2020-04-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I501- Left ventricular failure, unspecified Health Condition 2: I30-I52- Other forms of heart disease

Interventions

Control Intervention1: NIL: NIL Control Intervention2: NIL: NIL

Sponsors

Kasturba Medical College Manipal Academy of Higher Education Manipal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age greater than 18 years 2. Able to provide written and informed consent 3. Left ventricular ejection fraction less than 40% 4. NYHA II- IV symptoms 5. Newly diagnosed heart failure with reduced ejection fraction 6. Chronic heart failure with reduced ejection fraction patients who are on optimal medical treatment but not started on ARNI Sacubutril- Valsartan

Exclusion criteria

Exclusion criteria: 1. Recent coronary revascularization within 3 months 2. Hypotension 3. Renal dysfunction 4. Valvular heart disease other than mitral regurgitation 5. Recent cardiac resynchronization therapy device implantation within 3 months 6. Any contraindication for ARNI Sacubutril -Valsartan

Design outcomes

Primary

MeasureTime frame
Diastolic strain rate at the baseline and at 3 months after starting Sacubutril - Valsartan will be compared and will also be compared with the control groupTimepoint: 1. At baseline before starting Sacubutril- Valsartan 2. At 3 months after starting the treatment

Secondary

MeasureTime frame
Global longitudinal strain, E/E, LV Ejection fraction at baseline before starting the drug and after starting the drug , will be compared and will also be compared with the control groupTimepoint: 1. At baseline before starting Sacubutril- Valsartan 2. At 3 months after starting the treatment

Countries

India

Contacts

Public ContactDr Monika Jawanjal

Kasturba Medical College, Manipal Academy of Higher Education, Manipal

msudhakar88@gmail.com9902547712

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026