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

NCT ID: NCT03816306

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-12-01

Brief Summary

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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

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Conditions

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Heart Failure With Reduced Ejection Fraction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single group study

LCZ 696

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mohammed Alnims

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Alnims

Doctor, Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Magdy Abdelhamid, MD, FACC, FESC, FSCAI

Role: STUDY_DIRECTOR

Professor of Cardiovascular Medicine, Cairo University

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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31640

Identifier Type: -

Identifier Source: org_study_id

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