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

Clinision

Status: Completed

Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class IV

Treatments: Drug: Sacubitril / Valsartan Oral Tablet

Study type: Observational

Funder types: Other

Identifiers

NCT04218435

PK/IIS/001

Details and patient eligibility

About

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

Full 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).

Enrollment: 200 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Observational

Description:

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

Treatment:

Drug: Sacubitril / Valsartan Oral Tablet