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

Study Overview

• Status: Completed
• Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class IV
• Intervention / Treatment: Drug: Sacubitril / Valsartan Oral Tablet

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).

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54590
      • Doctors hospital and medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

130 patients of heart failure with NYHA (II-IV)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational; Sacubitril/valsartan is a combination of a neprilysin inhibitor, sacubitril and an angiotensin II receptor blocker, valsartan. The recommended starting dose is one 49/51 mg (sacubitril/valsartan) tablet twice-daily. Double the dose of Sacubitril/valsartan after 2 to 4 weeks to the target maintenance dose of 97/103 mg (sacubitril/valsartan) twice-daily, as tolerated by the patient. Reduce the starting dose to 24/26 mg (sacubitril/valsartan) twice-daily for: Patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents.; Patients with severe renal impairment (CrCl less than 30 ml/min); Patients with moderate hepatic impairment. (Child Pugh B) Double the dose of Sacubitril/valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg (sacubitril/valsartan) twice-daily, as tolerated by the patient

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.; Other Names: Sacvin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Clinision
• Investigators: Principal Investigator: Shahryar Shiekh, Doctors hospital and Medical center, Lahore

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): October 25, 2020
• Study Completion (ACTUAL): December 30, 2020

Study Registration Dates

• First Submitted: December 27, 2019
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (ACTUAL): January 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: chronickindeydisease, qualityoflife
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan; Sacubitril and valsartan sodium hydrate drug combination
• Other Study ID Numbers: PK/IIS/001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No