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Impact of Sacubitril/Valsartan on Quality of Life and Mortality of CKD vs Non-CKD in Heart Failure Patients

Impact of Sacubitril/Valsartan on Quality of Life and Mortality of CKD vs Non-CKD in Heart Failure Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04218435
Enrollment
200
Registered
2020-01-06
Start date
2019-01-01
Completion date
2020-12-30
Last updated
2021-02-01

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

Conditions

Heart Failure NYHA Class IV, Heart Failure NYHA Class II

Keywords

chronickindeydisease, qualityoflife

Brief summary

The two primary goals of it's management are preventing further disease progression(mortality,hospitalizations and deterioration of left ventricular function)and alleviating patient suffering

Detailed description

Heart failure (HF) is emerging as an epidemic in 3rd world countries. Despite significant therapeutic advances, patients with chronic heart failure remain at high risk for HF progression and death. The two primary goals of its management are preventing further disease progression(mortality, hospitalizations and deterioration of left ventricular function)and alleviating patient suffering.Sacubitril /valsartan (previously known as LCZ696) is a first-in-class medicine that contains a neprilysin (NEP )inhibitor(sacubitril) and an angiotensin II receptor blocker (valsartan). NEP is an endopeptidase that metabolizes different vasoactive peptides including natriuretic peptides, bradykinin and Ang -II. In consequence, its inhibition increases mainly the levels of both natriuretic peptides (promoting diuresis, natriuresis and vasodilation) and Ang- II whose effects are blocked by the angiotensin receptor blocker, valsartan (reducing vasoconstriction and aldosterone release).

Interventions

Sacubitril/Valsartan is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. Sacubitril/Valsartan is usually administered in conjunction with another heart failure therapies, in place of an ACE inhibitor or other ARB.

Sponsors

Clinision
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years

Inclusion criteria

1. Patients with heart failure (NYHA class II-IV). 2. LV EF(less than or equal to 40%). 3. eGFR (more than 30 ml/min /1.73m2).

Exclusion criteria

1. Symptomatic hypotension. 2. eGFR\<30 ml/min/1.73m2 . 3. Serum potassium \>5.2mmol/L 4. Angioedema

Design outcomes

Primary

MeasureTime frameDescription
Assess the result on the quality of life through Kansas city cardiomyopathy Questionnaire1 yearcomparison of the quality of life questionnaire before and after the treatment of sacubitril/ valsartan
Analyze the result on mortality of heart failure patients through Kansas city cardiomyopathy Questionnaire1 yearImprovement in mortality of heart failure patients after taking treatment of sacubitril/ valsartan.

Secondary

MeasureTime frameDescription
Incidence of acute kidney injury after taking angiotensin receptor neprilysin inhibitor1 yearchanges in the baseline of acute kidney injury, electrolyte imbalance and hemodynamic instability before and after taking treatment of sacubitril valsartan

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026