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Natriuretic Peptide System Enhancer
MANP + Sacubitril/Valsartan for Heart Failure
Phase 1 & 2
Waitlist Available
Led By Paul M McKie
Research Sponsored by Horng Chen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Exclusion of subjects with Diabetes or BMI>35 (because endogenous natriuretic peptide levels are low in obese subjects)
Previous diagnosis of HF with New York Heart Association (NYHA) functional class II-III symptoms on chronic diuretic therapy
Must not have
Constrictive pericarditis
Sarcoidosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
Summary
This trial tests two drugs, Sacubatril/Valsartan and MANP, in people with a challenging type of heart failure and kidney disease. Sacubatril/Valsartan helps relax blood vessels, while MANP may help the heart and kidneys by removing extra salt and water. The goal is to see if these treatments can improve symptoms and heart function.
Who is the study for?
This trial is for adults with heart failure that still have a normal amount of blood pumped from the heart (HFpEF) and also have chronic kidney disease, but not diabetes or severe obesity. They must be on stable diuretic medication and have certain levels of kidney function and symptoms according to NYHA class.
What is being tested?
The study tests two drugs: Sacubitril/Valsartan (Entresto) and MANP, against placebos to see how they affect people with HFpEF-CKD who get short of breath during exercise without signs of fluid retention. Participants will receive either one drug or placebo through oral or injection routes.
What are the potential side effects?
Possible side effects include changes in blood pressure, kidney function alterations, electrolyte imbalances like low sodium or potassium levels, dizziness due to low blood pressure, allergic reactions if sensitive to ingredients such as iodine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have diabetes and my BMI is 35 or less.
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I have heart failure with moderate symptoms and am on long-term water pills.
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I have been on a stable dose of a diuretic for at least 4 weeks.
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I do not have diabetes and my BMI is 35 or less.
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I have moderate heart condition symptoms.
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My kidney function, measured by eGFR, is between 15-80 mL/min/1.73m^2.
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My heart pumps well and has normal pressure readings.
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I have heart failure with preserved ejection fraction and kidney disease, with an ejection fraction of 55% or higher.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with constrictive pericarditis.
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I have been diagnosed with sarcoidosis.
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I have not had a stroke or significant brain blood flow issues in the last 3 months.
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I have a serious heart valve condition.
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I have a type of heart disease that thickens my heart muscle.
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I have been diagnosed with active inflammation of the heart muscle.
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I have Fabry disease.
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I was born with a serious heart condition.
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I have diabetes.
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I have been diagnosed with cardiac amyloidosis.
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I am currently pregnant or breastfeeding.
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I have high blood pressure in the lungs.
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I have not had unstable chest pain or signs of heart issues in the last 6 months.
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I have had a heart attack in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Composite Score of cGMP, sodium excretion, GFR, and Anx-A1 Plasma cGMP, urinary cGMP, urinary sodium excretion, GFR, ANX-A1acute VE with MANP
Body Weight Changes
Secondary study objectives
Change in Plasma NT-pro BNP
Change in Plasma cGMP
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: HFpEF-EI with Sacbitril/Valsartan with an injected placeboExperimental Treatment2 Interventions
Subjects with with HFpEF with exercise induced dyspnea (difficult or labored breathing) without clinical symptoms at rest (e.g. peripheral edema, weight gain, and abdominal distention) will receive study drug Sacbitril/Valsartan and an injected placebo followed by a 1 week washout period.
Group II: HFpEF-EI with MANP and oral placeboExperimental Treatment2 Interventions
Subjects with with HFpEF with exercise induced dyspnea (difficult or labored breathing) without clinical symptoms at rest (e.g. peripheral edema, weight gain, and abdominal distention) will receive study drug MANP and an oral placebo followed by a 1 week washout period.
Group III: HFpEF-CKD with Sacbitril/Valsartan with an injected placeboExperimental Treatment2 Interventions
Subjects with with HFpEF volume overload in the presence of chronic kidney diseases and clinical symptoms at rest (e.g. peripheral edema, weight gain, and abdominal distention) will receive study drug Sacbitril/Valsartan and an injected placebo followed by a 1 week washout period.
Group IV: HFpEF-CKD with MANP and oral placeboExperimental Treatment2 Interventions
Subjects with with HFpEF volume overload in the presence of chronic kidney diseases and clinical symptoms at rest (e.g. peripheral edema, weight gain, and abdominal distention) will receive study drug MANP and an oral placebo followed by a 1 week washout period.
Group V: HFpEF-EI with an oral and injected placeboPlacebo Group2 Interventions
Subjects with with HFpEF with exercise induced dyspnea (difficult or labored breathing) without clinical symptoms at rest (e.g. peripheral edema, weight gain, and abdominal distention) will receive an oral and injected placebo followed by a 1 week washout period.
Group VI: HFpEF-CKD with an oral and injected placeboPlacebo Group2 Interventions
Subjects with with HFpEF volume overload in the presence of chronic kidney diseases and clinical symptoms at rest (e.g. peripheral edema, weight gain, and abdominal distention) will receive an oral and injected placebo followed by a 1 week washout period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Injection Placebo
2020
Completed Phase 2
~250
MANP
2017
Completed Phase 1
~60
Sacubitril/Valsartan
2018
Completed Phase 4
~8060
Oral Placebo
2017
Completed Phase 4
~4560
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Heart Failure (HF) like Sacubatril/Valsartan and MANP work by enhancing natriuresis, diuresis, and vasodilation. Sacubatril/Valsartan combines neprilysin inhibition, which increases natriuretic peptides, and angiotensin II receptor blockade, which prevents vasoconstriction and cardiac remodeling.
MANP also promotes natriuresis, diuresis, and vasodilation. These mechanisms help reduce fluid overload, lower blood pressure, and improve cardiac function, which are essential for managing HF symptoms and reducing hospitalizations and mortality.
Find a Location
Who is running the clinical trial?
Horng ChenLead Sponsor
3 Previous Clinical Trials
107 Total Patients Enrolled
2 Trials studying Heart Failure
103 Patients Enrolled for Heart Failure
Paul M McKiePrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Heart Failure
60 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with constrictive pericarditis.Your ALT levels are more than twice the normal limit.I do not have diabetes and my BMI is 35 or less.I have been diagnosed with sarcoidosis.You are allergic to iodine.You have a certain type of heart block without a permanent pacemaker.I have not had a stroke or significant brain blood flow issues in the last 3 months.You experienced a specific type of heart rhythm problem within the past 14 days.I have a serious heart valve condition.I have a type of heart disease that thickens my heart muscle.I don't have any health issues that could make this study risky for me.I have been diagnosed with active inflammation of the heart muscle.I have Fabry disease.I was born with a serious heart condition.I have heart failure with moderate symptoms and am on long-term water pills.I have been on a stable dose of a diuretic for at least 4 weeks.Your blood pressure is too low (less than 100/60) or too high (more than 180/100).I have diabetes.I do not have diabetes and my BMI is 35 or less.I have been diagnosed with cardiac amyloidosis.Your hemoglobin level is lower than 9 grams per deciliter.I am currently pregnant or breastfeeding.Your kidney function is good, with a filtration rate of more than 50 mL per minute.You have a body mass index higher than 35.I have high blood pressure in the lungs.I have not had unstable chest pain or signs of heart issues in the last 6 months.I have moderate heart condition symptoms.I have had a heart attack in the last 6 months.My kidney function, measured by eGFR, is between 15-80 mL/min/1.73m^2.My heart pumps well and has normal pressure readings.Your blood sodium level is below 135 mEq/dL or above 160 mEq/dL.Your blood potassium level is lower than 3.5 mEq/dL or higher than 5.7 mEq/dL.I have heart failure with preserved ejection fraction and kidney disease, with an ejection fraction of 55% or higher.
Research Study Groups:
This trial has the following groups:- Group 1: HFpEF-EI with an oral and injected placebo
- Group 2: HFpEF-CKD with MANP and oral placebo
- Group 3: HFpEF-EI with MANP and oral placebo
- Group 4: HFpEF-CKD with an oral and injected placebo
- Group 5: HFpEF-CKD with Sacbitril/Valsartan with an injected placebo
- Group 6: HFpEF-EI with Sacbitril/Valsartan with an injected placebo
Awards:
This trial has 0 awards, including: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.
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