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

Completed

• Conditions: Heart Failure With Reduced Ejection Fraction
• Interventions: Drug: LCZ 696

• Registration Number: NCT03816306
• Lead Sponsor: Mohammed Alnims

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-25
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. ≥18 year old.
2. Functional class using New York Heart Association (NYHA) classification class II, III or IV %).
3. Left ventricular systolic dysfunction using transthoracic echocardiography with EF ≤ 40%.
4. Who was already taking ACE inhibitors or ARBs.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single group study	LCZ 696	-

Primary Outcome Measures

Name	Time	Method
Number of Participants That Had Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization.	6 Months after starting LCZ696 Therapy	Number of participants that had either CV death or HF hospitalization due to HF.
Change From Baseline to Month 6 for The Minnesota Living with Heart Failure Questionnaire (MLHFQ).	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 Outcome Measures

Name	Time	Method
Number of Patients with Changes in The Left Ventricular Systolic Function (EF).	6 Months after starting LCZ696 Therapy	Number of Patients with improvement in the ejection fraction.
Number of Patients - All-cause Mortality.	6 Months after starting LCZ696 Therapy	Number of patients - All-cause mortality. All-cause mortality is common in HF patients.
Number of Patients With First Confirmed Renal Dysfunction.	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 ).

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt