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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 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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
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-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
MANP
2017
Completed Phase 1
~60
Sacubitril/Valsartan
2018
Completed Phase 4
~8060
Injection Placebo
2020
Completed Phase 2
~250
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
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.
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."
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