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Natriuretic Peptide System Enhancer

Natriuretic Peptide Enhancement for Heart Failure

Mayo Clinic in Rochester, Rochester, MN
Targeting 2 different conditionsMANP +3 morePhase 1 & 2Waitlist AvailableLed by Paul M McKieResearch Sponsored by Horng Chen

Study Summary

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

Eligible Conditions
  • Diastolic Heart Failure
  • Chronic Kidney Disease

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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
Recent research and studies
clinicaltrials.govStudy
Enhancing the Natriuretic Peptide System in HFpEF
Horng Chen 2022. "Enhancing the Natriuretic Peptide System in HFpEF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05279742.
All > Entresto > Diovan
~40 spots leftby Apr 2027
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