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To study the clinical response and safety of angiotension receptor- neprilysin inhibitor ( sacubitril/valsartan ) in patients with advanced chronic kidney disease and heart failure with reduced ejection fraction

TO STUDY THE CLINICAL RESPONSE AND SAFETY OF ANGIOTENSIN RECEPTOR- NEPRILYSIN INHIBITOR (SACUBITRIL/ VALSARTAN) IN PATIENTS WITH ADVANCED CHRONIC KIDNEY DISEASE AND HEART FAILURE WITH REDUCED EJECTION FRACTION - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/085308
Enrollment
40
Registered
2025-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: N184- Chronic kidney disease, stage 4 (severe) Health Condition 2: N185- Chronic kidney disease, stage 5 Health Condition 3: I504- Combined systolic (congestive) anddiastolic (congestive) heart failure

Interventions

Intervention1: . To study the effect of Sacubitril /Valsartan on the rate of hospitalizations and symptoms during 6 months of treatment 2. To note the change in concentration of NT-pro BNP levels, p

Sponsors

Christian medical college and Hospital Ludhiana
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex aged between 18 and 80 years, 2. Mean sitting systolic blood pressure more than or equal to 110 mm Hg 3. Left ventricular ejection fraction less than or equal to 40% at baseline echocardiography. 4. NT-pro BNP levels more than 600 pg/mL.

Exclusion criteria

Exclusion criteria: 1. Patients with serum potassium more than 5.8 mmol/L at baseline 2. Patients with elevated SGOT, SGPT more than 2 times Upper Limit of Normal 3. Prior history of angioedema 4. Pregnancy

Design outcomes

Primary

MeasureTime frame
To study the effect of Sacubitril /Valsartan on the rate of hospitalizations and symptoms during 6 months of treatment 2. To note the change in concentration of NT-pro BNP levels, proteinurea, eGFR and LVEF from baseline after 6 months of treatment.Timepoint: 12 months of Recruitment and 6 months of follow up

Secondary

MeasureTime frame
1. To study the incidence of hyperkalaemia defined as serum potassium more than 6 meq/L during treatment with ARNI 2. To assess the decline in eGFR by more than 30% from baseline during treatment with ARNI Timepoint: 12 months of Recruitment and 6 months of follow up

Countries

India

Contacts

Public ContactDR GURJEEN KAUR MAKKAR

CHRISTIAN MEDICAL COLLEGE AND HOSPITAL , LUDHIANA

timothy256@gmail.com8360579637

Outcome results

None listed

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