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Completed

NCT Number: NCT03816306

Six Months Clinical and Echocardiographic Outcome of ARNI LCZ696 Therapy in HFrEF Patients

To evaluate the clinical and echocardiographic outcome of LCZ696 therapy in HFrEF (NYHA Class II - IV and EF =≤ 40%).patients, in addition to the efficacy of LCZ696 in reducing mortality and rehospitalisation rate.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥18 year old.
  • Functional class using New York Heart Association (NYHA) classification class II, III or IV %).
  • Left ventricular systolic dysfunction using transthoracic echocardiography with EF ≤ 40%.
  • Who was already taking ACE inhibitors or ARBs.

Exclusion criteria

  • Symptomatic hypotension.
  • Systolic blood pressure <100 mm Hg.
  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2.
  • History of angioedema.
  • Hisotry of unacceptable side effects while on while on treatment with an ACE-inhibitor or ARBs.

Treatment and study plan

LCZ 696

Drug

LCZ696 is an Angiotensin receptor neprilysin inhibitor. It's composed of Sacubitril/Valsartan. LCZ696 starting dose 50 mg P.O. BID, LCZ696 100 mg P.O. BID and up-titration to LCZ696 200 mg P.O. BID.

Primary outcomes

  1. Number of Participants That Had Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization.

    Time frame: 6 Months after starting LCZ696 Therapy

    Number of participants that had either CV death or HF hospitalization due to HF.

  2. Change From Baseline to Month 6 for The Minnesota Living with Heart Failure Questionnaire (MLHFQ).

    Time frame: 6 Months after starting LCZ696 Therapy

    Change From Baseline to Month 6 for the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The questionnaire was designed as a self-administered measure of the effects of heart failure and treatments for heart failure on patients' quality of life. The questionnaire has 21 items assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and social functions. The response scale for all 21 items on the MLHF is based on a 6-point ( from 0 to 5 ). Scores are transformed to a range of 0-105, in which higher scores reflect better health status.

Secondary outcomes

  1. Number of Patients - All-cause Mortality.

    Time frame: 6 Months after starting LCZ696 Therapy

    Number of patients - All-cause mortality. All-cause mortality is common in HF patients.

  2. Number of Patients With First Confirmed Renal Dysfunction.

    Time frame: 6 Months after starting LCZ696 Therapy

    Number of patients with first confirmed renal dysfunction ( a decrease in the eGFR of at least 50% or a decrease of more than 30 ml per minute per 1.73 m2 to less than 60 ml per minute per 1.73 m2 ).

  3. Number of Patients with Changes in The Left Ventricular Systolic Function (EF).

    Time frame: 6 Months after starting LCZ696 Therapy

    Number of Patients with improvement in the ejection fraction.

Sponsors and collaborators

Lead sponsor

Mohammed Alnims

Other

Registry information

Official study title

Six Months Clinical and Echocardiographic Outcome of Angiotensin Receptor-Neprilysin Inhibitor (ARNI) LCZ696 Therapy in Heart Failure Patients With Reduced Ejection Fraction (HFrEF)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2019
Registry last updated
Jan 18, 2020

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.

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