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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights

Study Summary

This trial is studying how two drugs affect people with different types of heart failure.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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-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.
Group VI: 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MANP
2017
Completed Phase 1
~60
Sacubitril/Valsartan
2018
Completed Phase 4
~8060
Oral Placebo
2017
Completed Phase 4
~3500

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-CKD with MANP and oral placebo, HFpEF-EI with MANP and oral placebo, HFpEF-CKD with Sacbitril/Valsartan with an injected placebo, HFpEF-EI with Sacbitril/Valsartan with an injected placebo, HFpEF-CKD with an oral and injected placebo, HFpEF-EI with an oral and 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more room for participants in this research project?

"The clinical trial you are inquiring about is not currently recruiting patients. Although this may be the case, it is important to know that there are 567 other trials which are actively seeking participants."

Answered by AI
~40 spots leftby Apr 2027