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

Heart Failure NYHA Class II Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04218435
• Other study ID #: PK/IIS/001
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: October 2019
• Source: Clinision
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 30, 2020
• Est. primary completion date: October 25, 2020
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure NYHA Class II
• Heart Failure NYHA Class IV

Intervention

Drug:
• Sacubitril / Valsartan Oral Tablet
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.

Locations

Country	Name	City	State
Pakistan	Doctors hospital and medical center	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Clinision

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the result on the quality of life through Kansas city cardiomyopathy Questionnaire	comparison of the quality of life questionnaire before and after the treatment of sacubitril/ valsartan	1 year
Primary	Analyze the result on mortality of heart failure patients through Kansas city cardiomyopathy Questionnaire	Improvement in mortality of heart failure patients after taking treatment of sacubitril/ valsartan.	1 year
Secondary	Incidence of acute kidney injury after taking angiotensin receptor neprilysin inhibitor	changes in the baseline of acute kidney injury, electrolyte imbalance and hemodynamic instability before and after taking treatment of sacubitril valsartan	1 year