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Angiotensin Receptor Neprilysin Inhibitor
Entresto + Aprepitant for Heart Failure
Phase 4
Recruiting
Led By Nancy J. Brown, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
EF ≤55%, and history of symptoms of New York Heart Association (NYHA) class I, II, or III heart failure (HF)
History of symptoms of New York Heart Association (NYHA) class I, II, or III heart failure (HF)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over six hours on each of the four study days
Awards & highlights
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.
Who is the study for?
This trial is for black and white men and women, aged 18 or older, with heart failure (NYHA Class I-III) and an ejection fraction (EF) ≤55%. Participants must have stable symptoms, no recent hospitalizations for heart failure, not be on LCZ696 currently, and if female and of childbearing potential, use reliable contraception. Excluded are those with allergies to study drugs or related chemicals, history of angioedema or certain cardiovascular events within the last six months.Check my eligibility
What is being tested?
The trial tests how blood pressure responds to a combination of Aprepitant vs Placebo during initiation and steady-state doses of Entresto (LCZ696). It's a double-blind study where participants randomly receive either the drug or placebo in two phases: starting dose (50 mg) and maintenance dose (200 mg bid or highest tolerated).See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medication components; changes in kidney function as measured by substances like Para-aminohippurate; contrast-related reactions due to Iohexol; gastrointestinal issues affecting drug absorption; hormonal imbalances impacting diabetes control.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart's pumping ability is reduced, and I've had mild to moderate heart failure symptoms.
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I have experienced mild to moderate heart failure symptoms.
Select...
I am 18 years old or older.
Select...
I am not currently taking LCZ696.
Select...
My heart pumps less blood than normal but my condition is stable.
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 moreTrial 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
2008
Completed Phase 4
~1900
LCZ 696
2018
N/A
~100
Placebo
1995
Completed Phase 3
~2670
Iohexol
2016
Completed Phase 4
~1920
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,361 Total Patients Enrolled
32 Trials studying Heart Failure
55,919 Patients Enrolled for Heart Failure
Nancy J. Brown, MDPrincipal InvestigatorYale University
2 Previous Clinical Trials
46 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Type 1 diabetes.I have had fainting spells due to irregular heartbeats.You have had a heart transplant, or are on a transplant list, or have a left ventricular assistance device.I might need heart or neck artery surgery within the next 6 months.My heart's pumping ability is reduced, and I've had mild to moderate heart failure symptoms.I have a stomach or bowel problem that affects how medicines work in my body.I have not taken DPP-4 inhibitors for my type 2 diabetes in the last month.I have low blood pressure or symptoms of it.I am currently taking lithium.I am not allergic to the study drugs or similar medications.I use my asthma inhaler more than once a week.I am a woman who is either postmenopausal, sterilized, using birth control, or willing to undergo pregnancy tests.I have not had severe heart failure symptoms in the last 3 months.You have had a bad reaction to contrast dye in the past.Your blood potassium level is higher than 5.2 mmol/L when tested before or during the study.I have not taken more than 5 mg of prednisone or similar steroids regularly in the past year.I understand the details and risks of the study.My kidney function is significantly reduced.I have had a serious brain condition like a stroke or seizure with lasting effects.My liver is not working well due to severe scarring.I have heart failure and have been on a stable heart medication for 4 weeks, unless I had bad reactions or kidney issues.I have a significant blockage in the heart's outflow tract.I have experienced mild to moderate heart failure symptoms.I have a history of immune or blood disorders.Your hematocrit level is less than 35%.You are currently breastfeeding or pregnant.I have a history of cancer, not including non-melanoma skin cancer, that is not considered cured.I have had pancreatitis or have known pancreatic lesions.I have a slow heartbeat or heart block without a pacemaker.I am 18 years old or older.I do not take regular medication for a condition that could affect the study.I have been on a stable dose of ACEi or ARB and a beta blocker for at least 4 weeks.I haven't had major heart or blood vessel surgery in the last 6 months.You have had swelling under the skin in the past.I am not currently taking LCZ696.I am either a black or white man or woman.My heart pumps less blood than normal but my condition is stable.My diabetes is not well-managed, with a HgbA1c level over 9%.I haven't been hospitalized for my heart condition in the last 3 months.I have a serious heart valve problem, but it's not due to my heart being enlarged.You have a history of alcohol or drug abuse.
Research Study Groups:
This trial has the following groups:- Group 1: aprepitant, placebo, aprepitant, placebo
- Group 2: aprepitant, placebo, placebo, aprepitant
- Group 3: placebo, aprepitant, aprepitant, placebo
- Group 4: placebo, aprepitant, placebo, aprepitant
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Heart Failure Patient Testimony for trial: Trial Name: NCT04649229 — Phase 4
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
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.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Can this study be completed remotely?
PatientReceived 2+ prior treatments
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