Skip to main content
OpenTrials
Completed

NCT Number: NCT04688294

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wadi El-Neel Hospital

Cairo, 11865, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 40 - 60 years
  • Patients with chronic congestive heart failure class ( II-IV) symptoms according to New York Heart Association (NYHA) classification
  • Left Ventricular Ejection Fraction of 40% or less.
  • NT-proBNP level of at least ≥400 pg per milliliter
  • ACE-inhibitor or ARB therapy with stable dose for prior 4 weeks, equivalent to enalapril ≥ 10 mg/day.

Exclusion criteria

  • Patients with symptomatic hypotension.
  • Pregnant and nursing women
  • Systolic blood pressure < 100 mmHg at screening or < 95 mmHg at randomization
  • Patients with glomerular filtration rate <30 mL/min/1.73 m2
  • Patients with history of angioedema
  • Patients with unacceptable side effects with ACE-inhibitors or ARBs.

Treatment and study plan

Sacubitril-valsartan

Drug

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

valsartan

Drug

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.

Primary outcomes

  1. change in NTproBNP plasma concentration

    Time frame: at baseline

    NTproBNP is a Biomarker used to assess severity of congestive heart failure)

  2. change in NTproBNP plasma concentration

    Time frame: at 6 months

    NTproBNP is a Biomarker used to assess severity of congestive heart failure)

  3. severity of congestive heart failure.

    Time frame: at baseline

    Ejection fraction

  4. severity of congestive heart failure.

    Time frame: at 6 months

    Ejection fraction

Secondary outcomes

  1. change in plasma potassium concentration

    Time frame: every month, up to 6 months

    plasma potassium (intracellular cation) concentration used to evaluate Sacubitril-Valsartan

  2. change in serum sodium concentration

    Time frame: every month, up to 6 months

    serum sodium (extracellular cation) concentration used to evaluate Sacubitril-Valsartan

  3. change in serum creatinine

    Time frame: every month, up to 6 months

    serum creatinine which is a byproduct of muscle protein metabolism is used to evaluate Sacubitril-Valsartan

Sponsors and collaborators

Lead sponsor

Amir Safwat

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2020
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.