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

NCT04218435 | Completed FDA Drug

• 1 other identifier: PK/IIS/001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure NYHA Class IV; Heart Failure NYHA Class II

Keywords

chronickindeydisease, qualityoflife

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of acute kidney injury after taking angiotensin receptor neprilysin inhibitor

  1 year

Study Arms (1)

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

Interventions

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.

Also known as: Sacvin

Observational

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Clinision: lead

Study Sites (1)

Doctors hospital and medical center

Lahore, Punjab Province, 54590, Pakistan

Location

MeSH Terms

Interventions

sacubitril and valsartan sodium hydrate drug combination

Study Officials

• Shahryar Shiekh

  Doctors hospital and Medical center, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 6, 2020
• Study Start: January 1, 2019
• Primary Completion: October 25, 2020
• Study Completion: December 30, 2020
• Last Updated: February 1, 2021

Record last verified: 2019-10

Locations

PA (1)