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

NCT ID: NCT04218435

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-12-30

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).

Conditions

Heart Failure NYHA Class IV; Heart Failure NYHA Class II

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Sacubitril / Valsartan Oral Tablet

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Sacvin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinision

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shahryar Shiekh

Role: PRINCIPAL_INVESTIGATOR

Doctors hospital and Medical center, Lahore

Locations

Doctors hospital and medical center

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

PK/IIS/001

Identifier Type: -

Identifier Source: org_study_id