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Clinical Trial Details

Trial ID: L1220
Source ID: NCT05279742
Associated Drug: Manp
Title: Enhancing the Natriuretic Peptide System in HFpEF
Acronym:
Status: ENROLLING_BY_INVITATION
Study Results: NO
Results:
Conditions: Heart Failure with Preserved Ejection Fraction|Chronic Kidney Diseases
Interventions: DRUG: MANP|DRUG: Sacubitril/Valsartan|DRUG: Oral Placebo|DRUG: Injection Placebo
Outcome Measures: Primary: Change in Plasma ANP, Change in Plasma ANP (pg/ml) level after administration of study drug/placebo compared to baseline in response to volume expansion in HFpEF-EI vs HFpEF-CKD., 24 hours|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, A composite score of change in urinary cGMP (pmol/min), sodium excretion (mEq/min), GFR (ml/min), and Anx-A1 (pg/ml) after administration of study drug/placebo compared to baseline in response to volume expansion in HFpEF-EI vs HFpEF-CKD within each treatment group., 24 hours | Secondary: Change in Plasma NT-pro BNP, Change in Plasma NT-pro BNP (pg/ml) after administration of study drug/placebo compared to baseline in response to volume expansion in HFpEF-EI vs HFpEF-CKD., 24 hours|Change in Plasma cGMP, Change in plasma cGMP (pmol/ml) after administration of study drug/placebo compared to baseline in response to volume expansion in HFpEF-EI vs HFpEF-CKD., 24 hours
Sponsor/Collaborators: Sponsor: Horng Chen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-11-04
Completion Date: 2027-04
Results First Posted:
Last Update Posted: 2024-10-04
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States
URL: https://clinicaltrials.gov/show/NCT05279742