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

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03816306
• Other study ID #: 31640
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: January 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Drug:
• LCZ 696
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.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Mohammed Alnims

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants That Had Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization.	Number of participants that had either CV death or HF hospitalization due to HF.	6 Months after starting LCZ696 Therapy
Primary	Change From Baseline to Month 6 for The Minnesota Living with Heart Failure Questionnaire (MLHFQ).	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.	6 Months after starting LCZ696 Therapy
Secondary	Number of Patients - All-cause Mortality.	Number of patients - All-cause mortality. All-cause mortality is common in HF patients.	6 Months after starting LCZ696 Therapy
Secondary	Number of Patients With First Confirmed Renal Dysfunction.	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 ).	6 Months after starting LCZ696 Therapy
Secondary	Number of Patients with Changes in The Left Ventricular Systolic Function (EF).	Number of Patients with improvement in the ejection fraction.	6 Months after starting LCZ696 Therapy