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The Bio-Clinical Effects of the (Sacubitril-Valsartan) Combination on Patients With Chronic Heart Failure

NCT04688294 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-06-24

No results posted yet for this study

Summary

The aim of this study is to evaluate the bio-clinical effects of sacubitril/valsartan combination in treatment of patients with Congestive heart failure. Moreover, the investigators aim to evaluate side effects of this combination.

\- The following parameters were determined at baseline and at end of the study at 6 months of the beginning.

1. New York Heart Association (NYHA) Class.
2. Frequency of hospitalization by acute exacerbation of CHF
3. NT-ProBNP
4. Left ventricular systolic function by Echocardiography

Moreover, the side effects of the drugs used during study was assessed by

1. Renal function (Serum creatinine) was performed every month till the end of the study.
2. Serum electrolytes (Potassium and Sodium) was performed every month till the end of the study.

Conditions

Interventions

DRUG

Sacubitril-Valsartan

30 patients initially received Sacubitril/Valsartan at 24/26 mg twice daily orally then dose was doubled as tolerated every 2-4 weeks to reach the target maintenance dose 97 mg/103 mg twice daily

DRUG

Valsartan

30 patients received valsartan, starting at a dose of 40 mg/day orally. The dose was then doubled every 1-2 weeks on the basis of their blood pressure to reach a dose of 160 mg once daily according to guideline-directed medical therapy.

Sponsors & Collaborators

  • Amir Safwat

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-05-01
Completion
2021-07-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04688294 on ClinicalTrials.gov