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

NCT03816306 | Completed FDA Drug

• 1 other identifier: 31640
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Number of Patients - All-cause Mortality.

  6 Months after starting LCZ696 Therapy

• Number of Patients With First Confirmed Renal Dysfunction.

  6 Months after starting LCZ696 Therapy

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

  6 Months after starting LCZ696 Therapy

Study Arms (1)

Single group study

Drug: LCZ 696

Interventions

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.

Single group study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any Patients with HFrEF (EF ≤ 40%) above 18 year old.

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohammed Alnims: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

sacubitril and valsartan sodium hydrate drug combination

Study Officials

• Magdy Abdelhamid, MD, FACC, FESC, FSCAI

  Professor of Cardiovascular Medicine, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor, Investigator

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 25, 2019
• Study Start: June 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)