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Angiotensin Receptor Blocker/Neprilysin Inhibitor
LCZ696 for Heart Failure
Phase 4
Recruiting
Led By Nancy J. Brown, M.D.
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stable patients with a reduced ejection fraction (EF) ≤40%
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 four study days
Awards & highlights
Study Summary
This trial is testing the hypothesis that the effects of LCZ696 on blood pressure, natriuresis, and diuresis at initiation are due to the inhibition of neprilysin, which degrades endogenous bradykinin. The study will enroll 80 subjects with stable heart failure who will be given LCZ696 50 mg and either the bradykinin B2 receptor antagonist icatibant or placebo vehicle in random order (double-blind).
Who is the study for?
This trial is for stable heart failure patients with reduced ejection fraction (EF ≤40%), not hospitalized in the last six months, and on a stable dose of ACEi or ARB and beta blocker. It includes both men and women who are either postmenopausal, surgically sterilized, or using reliable birth control if of childbearing potential.Check my eligibility
What is being tested?
The study tests LCZ696's effects on blood pressure, natriuresis (sodium excretion), and diuresis (urine production) in heart failure patients. It involves stopping current ACEi/ARB medication, taking LCZ696 with placebo or icatibant (a bradykinin B2 receptor antagonist), followed by an up-titration protocol to assess changes.See study design
What are the potential side effects?
Potential side effects may include hypotension due to vasodilation from increased bradykinin levels when starting LCZ696. Other risks involve reactions to contrast agents used during testing, as well as general drug-related allergies or sensitivities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart pumps less blood than normal but my condition is stable.
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I have experienced symptoms of heart failure but can still perform daily activities.
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I haven't been hospitalized in the last 6 months.
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I am not currently taking LCZ696.
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
Urine sodium excretion
mean arterial pressure
Secondary outcome measures
Glomerular filtration rate
Heart rate
Renal plasma flow
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: placebo, icatibant, placebo, icatibantExperimental 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 icatibant. 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 icatibant, respectively.
Group II: placebo, icatibant, icatibant, 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 icatibant. 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 icatibant and placebo, respectively.
Group III: icatibant, placebo, placebo, icatibantExperimental Treatment5 Interventions
After a 48-hr washout, participants in this arm will be given LCZ696 50 mg and icatibant. 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 icatibant, respectively.
Group IV: icatibant, placebo, icatibant placeboExperimental Treatment5 Interventions
After a 48-hr washout, participants in this arm will be given LCZ696 50 mg and icatibant. 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 icatibant and placebo, respectively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
placebo
2010
Completed Phase 4
~6580
LCZ 696
2018
N/A
~100
Icatibant
2009
Completed Phase 4
~610
Iohexol
2016
Completed Phase 4
~1920
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,077 Total Patients Enrolled
12 Trials studying Heart Failure
4,933 Patients Enrolled for Heart Failure
Nancy J. Brown, M.D.Principal Investigator - Vanderbilt University Medical Center
Vanderbilt University Medical Center
1 Previous Clinical Trials
455 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the details and risks of the study.I have been on a stable dose of ACEi or ARB and a beta blocker for at least 4 weeks.I have had severe heart failure in the last 3 months.I have low blood pressure or symptoms of it.I have not taken long-term steroid pills in the past year.You have had angioedema in the past.I am currently taking lithium.I have had fainting spells due to irregular heartbeats.I am a woman who is either postmenopausal, sterilized, or if able to have children, I use birth control and agree to regular pregnancy tests.I haven't had major heart or blood vessel surgery in the last 6 months.I have a significant blockage in the heart's outflow tract.I have a slow heartbeat or heart block without a pacemaker.I have heart failure and have been on a stable heart medication for 4 weeks, unless it was not suitable for my kidney function or potassium levels.I might need heart or neck artery surgery within the next 6 months.My type 2 diabetes is not well-managed, with a HgbA1c over 9%.I have a serious heart valve problem, but it's not due to my heart being enlarged.You have had a bad reaction to contrast dye in the past.I am not allergic to the study drugs or similar medications.I have had pancreatitis or have known pancreatic lesions.I don't have any health conditions that could interfere with the study.You have a history of alcohol or drug abuse.You are currently breastfeeding or pregnant.Your hematocrit level is less than 35%.I have a history of immune or blood disorders.I use my asthma inhaler more than once a week.My heart pumps less blood than normal but my condition is stable.I have had a serious brain condition like a stroke or seizure.I am either a black or white man or woman.You have had a heart transplant, are waiting for one, or are using a left ventricular assistance device.I have experienced symptoms of heart failure but can still perform daily activities.Your blood potassium level is higher than a certain number at the beginning or during the study.I have a history of cancer, except for non-dangerous skin cancer.I have been taking DPP-4 inhibitors for my type 2 diabetes for at least a month.I have Type 1 diabetes.My liver tests (AST or ALT) are more than three times the normal range.My kidney function is significantly reduced.I haven't been hospitalized in the last 6 months.I am not currently taking LCZ696.I have a digestive issue that affects how my body absorbs medication.
Research Study Groups:
This trial has the following groups:- Group 1: icatibant, placebo, icatibant placebo
- Group 2: placebo, icatibant, placebo, icatibant
- Group 3: placebo, icatibant, icatibant, placebo
- Group 4: icatibant, placebo, placebo, icatibant
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you elucidate what other experiments have been conducted with Icatibant as a factor?
"At present, 45 trials are researching Icatibant with 8 of these in Phase 3. These studies relevant to this treatment take place largely around Montreal, Quebec, but there is a total of 997 locations where such research is being conducted."
Answered by AI
What is the enrollment capacity for this clinical research?
"Affirmative. The information provided on clinicaltrials.gov confirms that this research, which was posted initially on 11th November 2019, is currently looking for volunteers. 80 participants need to be recruited from 1 locale."
Answered by AI
What are the fundamental aims of this experiment?
"The primary outcome measure of this clinical trial, evaluated over a period of 8 hours, is urine sodium excretion. Secondary objectives include the measurement of urine volume for 6 hours post-administration LCZ696 on each study day, heart rate prior to and after LCZ696 per study day, as well as UACR (urine albumin-to creatinine ratio) measured pre and post administration in all days."
Answered by AI
What symptoms does Icatibant typically address?
"Icatibant is chiefly prescribed for angioedema, though it can be given as a remedy to address essential hypertension and conditions like ventricular dysfunction or left contrast enhancement."
Answered by AI
How secure is the use of Icatibant for patients?
"Due to the fact that Icatibant is an approved treatment, our team at Power assigned it a score of 3 in terms of safety."
Answered by AI
Is enrollment for this research project currently open?
"Affirmative. The clinicaltrials.gov website indicates that this trial is currently enrolling participants, which was first announced on November 1st 2019 and most recently updated June 1st 2022. For the study to reach its desired sample size of 80 individuals, it must recruit from one location."
Answered by AI
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