NCT04688294

Brief 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. 1.New York Heart Association (NYHA) Class.
  2. 2.Frequency of hospitalization by acute exacerbation of CHF
  3. 3.NT-ProBNP
  4. 4.Left ventricular systolic function by Echocardiography
  5. 5.Renal function (Serum creatinine) was performed every month till the end of the study.
  6. 6.Serum electrolytes (Potassium and Sodium) was performed every month till the end of the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 heart-failure

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_4 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

1.3 years

First QC Date

December 19, 2020

Last Update Submit

June 18, 2022

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (4)

  • change in NTproBNP plasma concentration

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

    at baseline

  • change in NTproBNP plasma concentration

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

    at 6 months

  • severity of congestive heart failure.

    Ejection fraction

    at baseline

  • severity of congestive heart failure.

    Ejection fraction

    at 6 months

Secondary Outcomes (3)

  • change in plasma potassium concentration

    every month, up to 6 months

  • change in serum sodium concentration

    every month, up to 6 months

  • change in serum creatinine

    every month, up to 6 months

Study Arms (2)

Sacubitril/valsartan

EXPERIMENTAL

Group 30 patients will undergo treatment with sacubitril/valsartan combination according to guideline-directed medical therapy.

Drug: Sacubitril-Valsartan

Valsartan

ACTIVE COMPARATOR

Group 30 patients will undergo treatment with valsartan according to guideline-directed medical therapy.

Drug: Valsartan

Interventions

Sacubitril-ValsartanDRUG

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

Sacubitril/valsartan
ValsartanDRUG

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.

Valsartan

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wadi El-Neel Hospital

Cairo, 11865, Egypt

Location

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combinationValsartan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Teaching assistant

Study Record Dates

First Submitted

December 19, 2020

First Posted

December 29, 2020

Study Start

January 1, 2020

Primary Completion

May 1, 2021

Study Completion

July 1, 2021

Last Updated

June 24, 2022

Record last verified: 2022-06

Locations

EG(1)