Effects of Different Forms of a Natural Heart Hormone on Blood Pressure and Fluid Balance in Healthy Volunteers

NCT07606183 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-05-26

No results posted yet for this study

Summary

The human heart produces hormones that help regulate blood pressure and fluid balance in the body. One of these hormones is atrial natriuretic peptide (ANP). ANP lowers blood pressure by relaxing blood vessels and increasing urinary excretion by the kidneys.

Previous research has demonstrated that ANP naturally carries a small sugar molecule attached. This sugar moiety is produced endogenously and can modify the biological activity of ANP. When this sugar is present, ANP may affect blood vessels and renal function differently compared with the non-glycosylated form.

The present study examines how this sugar modification alters the physiological effects of ANP. This is achieved by administering ANP, either with or without the attached sugar molecule, via intravenous infusion. The study aims to determine whether glycosylated ANP differs from the native form in its effects on blood pressure and fluid balance.

Conditions

Interventions

OTHER

Infusion of two different cardiac peptides plus vehicle

Interventions Original protocol: ANP: 200 pmol/kg/min for 120 minutes gANP: 200 pmol/kg/min for 120 minutes Amended protocol: ANP: 200 pmol/kg/min for 60 minutes gANP: 300 pmol/kg/min for 60 minutes Control: Saline infusion at 0.7 mL/kg/hour

Sponsors & Collaborators

  • Region Hovedstadens Apotek

    collaborator OTHER_GOV
  • Rigshospitalet, Denmark

    collaborator OTHER
  • University Hospital Bispebjerg and Frederiksberg

    collaborator OTHER
  • Peter Fruergaard Andersen

    lead OTHER

Principal Investigators

  • Katrine T-B Schjoldager, Associate Professor · Department of Cellular and Molecular Medicine, University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-03-30
Completion
2026-03-30

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07606183 on ClinicalTrials.gov