Heart Failure With Reduced Ejection FractionNCT03816306
Six Months Clinical and Echocardiographic Outcome of ARNI LCZ696 Therapy in HFrEF Patients
An observational study of Heart Failure With Reduced Ejection Fraction, run by Mohammed Alnims at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- LCZ 696
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any Patients with HFrEF (EF ≤ 40%) above 18 year old.
Who may be able to join
- ≥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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Being tested
- LCZ 696
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCZ 696Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Single group study | Not described Receives: Drug: LCZ 696 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 Months after starting LCZ696 Therapy
Secondary outcomes (3)
Number of Patients - All-cause Mortality.
Number of patients - All-cause mortality. All-cause mortality is common in HF patients.
Measured: 6 Months after starting LCZ696 Therapy
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 ).
Measured: 6 Months after starting LCZ696 Therapy
Number of Patients with Changes in The Left Ventricular Systolic Function (EF).
Number of Patients with improvement in the ejection fraction.
Measured: 6 Months after starting LCZ696 Therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Jun 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammed Alnims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammed Alnims, Cairo University
- Investigators
- Magdy Abdelhamid, MD, FACC, FESC, FSCAI, Study director, Professor of Cardiovascular Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816306
- Sponsor's protocol ID
- 31640
- Status last verified
- Jan 2020
- First submitted
- 22 Jan 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03816306
- Acronym / sponsor ID
- 31640
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mohammed AlnimsUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group study | – | Drug: LCZ 696 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any Patients with HFrEF (EF ≤ 40%) above 18 year old.
Key inclusion criteria (4 listed)
- ≥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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCZ 696LCZ696 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. | Drug | Single group study |
Primary outcome
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.
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.
3 secondary outcomes
Number of Patients - All-cause Mortality.
Time frame: 6 Months after starting LCZ696 Therapy
Number of Patients With First Confirmed Renal Dysfunction.
Time frame: 6 Months after starting LCZ696 Therapy
Number of Patients with Changes in The Left Ventricular Systolic Function (EF).
Time frame: 6 Months after starting LCZ696 Therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdy Abdelhamid, MD, FACC, FESC, FSCAI study director
Professor of Cardiovascular Medicine, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Reduced Ejection Fraction, run by Mohammed Alnims at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Had Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization. (time frame: 6 Months after starting LCZ696 Therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.