Enhancing the Natriuretic Peptide System in HFpEF

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Horng Chen
Study ID
NCT05279742
Phase
PHASE1/PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MANP — DRUG
    Single subcutaneous injection 5 µg/Kg
  • Sacubitril/Valsartan — DRUG
    Oral single dose 97/103 mg
  • Oral Placebo — DRUG
    Oral single dose that contains no active ingredient
  • Injection Placebo — DRUG
    Single subcutaneous injection that contains no active ingredient

Study Details

The purpose of this study is to look at the differences in how individuals with heart failure with preserved ejection fraction in the presence of chronic kidney disease (HFpEF-CKD) and exercise induced dyspnea without objective findings of fluid retention (HFpEF-EI) bodies function using drugs Sacubatril/Valsartan (Entresto) and MANP.

Key Dates

Start date
Nov 4, 2022
Status verified
Oct 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: HFpEF-CKD with MANP and oral placebo
    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.
  • Experimental: HFpEF-EI with MANP and oral placebo
    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.
  • Experimental: HFpEF-CKD with Sacbitril/Valsartan with an injected placebo
    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.
  • Experimental: HFpEF-EI with Sacbitril/Valsartan with an injected placebo
    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.
  • Placebo Comparator: HFpEF-CKD with an oral and injected placebo
    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.
  • Placebo Comparator: HFpEF-EI with an oral and injected placebo
    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.

Primary Outcome Measure

Change in Plasma ANP [ Time Frame: 24 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Rochester, MN

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Mayo Clinic in Rochester· Rochester, MN

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