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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

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
~3530

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

MANP (Natriuretic Peptide System Enhancer) Clinical Trial Eligibility Overview. Trial Name: NCT05279742 — Phase 1 & 2
Heart Failure Research Study Groups: HFpEF-EI with an oral and injected placebo, HFpEF-CKD with MANP and oral placebo, HFpEF-EI with MANP and oral placebo, HFpEF-CKD with an oral and injected placebo, HFpEF-CKD with Sacbitril/Valsartan with an injected placebo, HFpEF-EI with Sacbitril/Valsartan with an injected placebo
Heart Failure Clinical Trial 2023: MANP Highlights & Side Effects. Trial Name: NCT05279742 — Phase 1 & 2
MANP (Natriuretic Peptide System Enhancer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05279742 — Phase 1 & 2
~35 spots leftby Apr 2027
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