Angiotensin Receptor Neprilysin Inhibitor
Aprepitant for Heart Failure
Yale New Haven Hospital, New Haven, CT
Aprepitant +4 morePhase 4RecruitingLed by Nancy J. Brown, MDResearch Sponsored by Yale UniversityEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Black and white men and women
EF ≤55%, and history of symptoms of New York Heart Association (NYHA) class I, II, or III heart failure (HF)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upover six hours on each of the four study days
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Study Summary
This trial is testing whether a drug called Entresto, which is given to people with heart failure, is more effective when taken with or without another drug called Aprepitant.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
Men and women of all races and ethnic backgrounds, including Black and white individuals.
Select...
Your heart is not pumping well (EF ≤55%) and you have experienced symptoms of heart failure like shortness of breath or fatigue.
Select...
If you have moderate to severe heart failure and a weakened heart, you must have been taking a certain medication called a mineralocorticoid receptor antagonist for at least four weeks without any problems, unless your kidneys aren't working well or you had bad side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over six hours on each of four study days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over six hours on each of four study days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean arterial pressure (MAP)
Urine sodium excretion
Secondary outcome measures
Glomerular filtration rate
Heart rate
Renal plasma flow
+2 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
4Treatment groups
Experimental Treatment
Group I: placebo, aprepitant, placebo, aprepitantExperimental Treatment5 Interventions
After a 48-hr washout, participants in this arm will be given LCZ696 50 mg and placebo (vehicle). After a 96-hr washout period, subjects will be given LCZ696 50 mg and aprepitant. Participants will then undergo uptitration of LCZ696 over seven weeks. On the 7th and 10th days of the 200 mg bid or highest tolerated dose of LCZ696, participants in this arm will receive placebo and aprepitant, respectively.
Group II: placebo, aprepitant, aprepitant, placeboExperimental Treatment5 Interventions
After a 48-hr washout, participants in this arm will be given LCZ696 50 mg and placebo (vehicle). After a 96-hr washout period, subjects will be given LCZ696 50 mg and aprepitant. Participants will then undergo uptitration of LCZ696 over seven weeks. On the 7th and 10th days of the 200 mg bid or highest tolerated dose of LCZ696, participants in this arm will receive aprepitant and placebo, respectively.
Group III: aprepitant, placebo, placebo, aprepitantExperimental Treatment5 Interventions
After a 48-hr washout, participants in this arm will be given LCZ696 50 mg and aprepitant. After a 96-hr washout period, subjects will be given LCZ696 50 mg and placebo. Participants will then undergo uptitration of LCZ696 over seven weeks. On the 7th and 10th days of the 200 mg bid or highest tolerated dose of LCZ696, participants in this arm will receive placebo and aprepitant, respectively.
Group IV: aprepitant, placebo, aprepitant, placeboExperimental Treatment5 Interventions
After a 48-hr washout, participants in this arm will be given LCZ696 50 mg and aprepitant. After a 96-hr washout period, subjects will be given LCZ696 50 mg and placebo. Participants will then undergo uptitration of LCZ696 over seven weeks. On the 7th and 10th days of the 200 mg bid or highest tolerated dose of LCZ696, participants in this arm will receive aprepitant and placebo, respectively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aprepitant
FDA approved
Sacubitril
FDA approved
Placebo
1995
Completed Phase 3
~2670
Iohexol
FDA approved
Find a site
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,760 Previous Clinical Trials
2,689,830 Total Patients Enrolled
30 Trials studying Heart Failure
54,999 Patients Enrolled for Heart Failure
Nancy J. Brown, MDPrincipal Investigator
Yale University2 Previous Clinical Trials
46 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary goal of this medical experiment?
"The primary outcome of this research trial, which will be measured over six hours post-medication administration, is Mean Arterial Blood Pressure (MAP). Secondary objectives encompass Glomerular Filtration Rate (GFR) evaluated through iohexol clearance pre and post LCZ66 on study days; Urine Albumin to Creatinine Ratio (UACR), also determined prior and after the drug's introduction; as well as measuring total urine output from medication intake onwards."
Answered by AI
In what clinical applications is LCZ 696 commonly prescribed?
"LCZ 696 has been found to be a beneficial adjunct for cancer chemotherapy, treating hypertension with multiple drugs, and managing hypesthesia."
Answered by AI
Have any other studies been conducted with regard to LCZ 696?
"Currently, 51 clinical studies are underway to research the effects of LCZ 696. Of these trials, 10 have reached Phase 3 status. Montreal is home base for many of the investigations; however, 1008 sites across the world are also conducting tests on this medication."
Answered by AI
Has the Food and Drug Administration indicated its acceptance of LCZ 696 for public use?
"The safety of LCZ 696 is deemed to be a 3 on our team's assessment scale, due to the compound being approved for use in Phase 4 clinical trials."
Answered by AI
What is the fullest extent of persons taking part in this research endeavor?
"Affirmative. Clinicaltrials.gov confirms that this study, first posted on May 27th 2021, is actively seeking participants. 80 volunteers need to be recruited from 1 location for the trial to begin."
Answered by AI
Are new participants being sought for this clinical experiment?
"The clinical trial is currently searching for volunteers, as per its listing on the clinicaltrials.gov platform which was initially posted in May 2021 and recently adjusted in June 2022."
Answered by AI
Who else is applying?
What state do they live in?
Louisiana
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
What questions have other patients asked about this trial?
Can this study be completed remotely?
Patient
Why did patients apply to this trial?
I'm currently taking Entresto in combination with Furosemide and Coreg to treat Heart Failure, specifically Cardiomyopathy and CHF, and have recently found myself experiencing symptoms more frequently.
Patient
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