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Cardiac outcomes with addition of Sacubitril-Valsartan in dialysis patients with heart failure â?? a pilot study

Assessment of Cardiovascular Outcomes with Addition of Sacubitril-Valsartan in Dialysis Patients with Systolic and Diastolic Dysfunction - A Pilot Study

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/048730
Enrollment
100
Registered
2023-01-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: N186- End stage renal disease

Interventions

Intervention1: Drug Sacubitril-Valsartan : Study drug â?? sacubitril-valsartan will be administered in the study group starting at 24mg/26mg twice daily and up titrated as per the blood pressure and

Sponsors

IQRAA Hospital, Calicut
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Chronic kidney disease stage 5, on maintanence dialysis - Systolic dysfunction with EF - 18-75years - 3/week HD or nocturnal HD or frequent HD with optimised UF (adequacy as assessed as per discretion of nephrologist)

Exclusion criteria

Exclusion criteria: - Age 75 years - Non-compliant with medications/ dialysis (assessed as per discretion of nephrologist), Interdialytic weight gain > 3.5 litres - Refractory hyperkalemia defined at pre-dialyisis potassium > 6mmol/L - Clinical significant/ life-threatening Infection, requiring hospitalization in last 3 months - Malignancy - Pregnancy

Design outcomes

Primary

MeasureTime frame
composite of cardiovascular death, MACE, hospitalization for heart failure, death from any causeTimepoint: 3 months and 6 months

Secondary

MeasureTime frame
Incidence of hypotensive episodes after starting study drug, as assessed by nephrologist Incidence of pre-dialysis hyperkalemia more than 6mmol/L Timepoint: 6 months

Countries

India

Contacts

Public ContactShabna Sulaiman

IQRAA hospital

shabnasulaimanss@gmail.com8283831511

Outcome results

None listed

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