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OpenTrials
Completed

NCT Number: NCT04218435

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Doctors hospital and medical center

Lahore, Punjab Province, 54590, Pakistan

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Symptomatic hypotension.
  • eGFR<30 ml/min/1.73m2 .
  • Serum potassium >5.2mmol/L
  • Angioedema

Treatment and study plan

Sacubitril / Valsartan Oral Tablet

Drug

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.

Other names: Sacvin

Primary outcomes

  1. Assess the result on the quality of life through Kansas city cardiomyopathy Questionnaire

    Time frame: 1 year

    comparison of the quality of life questionnaire before and after the treatment of sacubitril/ valsartan

  2. Analyze the result on mortality of heart failure patients through Kansas city cardiomyopathy Questionnaire

    Time frame: 1 year

    Improvement in mortality of heart failure patients after taking treatment of sacubitril/ valsartan.

Secondary outcomes

  1. Incidence of acute kidney injury after taking angiotensin receptor neprilysin inhibitor

    Time frame: 1 year

    changes in the baseline of acute kidney injury, electrolyte imbalance and hemodynamic instability before and after taking treatment of sacubitril valsartan

Sponsors and collaborators

Lead sponsor

Clinision

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 6, 2020
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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