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

NCT07606183 | Completed Early Phase 1 DMC

• 1 other identifier: 77354/H-21000305
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure; Hypertension; Kidney Failure

Keywords

ANP, atrial natriuretic peptide; glycosylation, post-translational modification, peptide

Outcome Measures

Primary Outcomes (1)

• Diuresis and natriuresis

  Primary Objective Diuresis and natriuresis are quantified immediately after conclusion of peptide/placebo administration and repeated after an additional two hours of observation.

  Collection and quantification will take place after completion of two hours of peptide/placebo administration and again after two hours of observation

Secondary Outcomes (3)

• Blood pressure

  Measurement will take place every ten minutes throughout the experimental day.

• Metabolic markers

  During and after infusion of peptide/placebo with 20-30 min interval.

• cyclic GMP

  Quantification will take place once every hour (plasma) and every two hours (urine)

Study Arms (3)

Atrial Natriuretic Peptide (ANP) - a well described cardiac hormone

ACTIVE COMPARATOR

Atrial Natriuretic Peptide (ANP) Participants receive an intravenous infusion of native atrial natriuretic peptide (ANP), a naturally occurring heart hormone known to lower blood pressure by relaxing blood vessels and increasing salt and water excretion by the kidneys. ANP is administered at a fixed weight-adjusted dose over a defined infusion period, followed by post-infusion observation and monitoring of blood pressure, urine output, and blood markers.

Other: Infusion of two different cardiac peptides plus vehicle

Glycosylated Atrial Natriuretic Peptide (gANP) - a naturally occurring modified cardiac hormone

EXPERIMENTAL

Participants receive an intravenous infusion of glycosylated atrial natriuretic peptide (gANP), a naturally occurring sugar-modified form of ANP. Glycosylation alters the stability and biological activity of the hormone. gANP is administered at a weight-adjusted dose comparable to or slightly higher than native ANP, according to protocol amendments, with the same monitoring procedures. The purpose is to assess whether the sugar-modified form produces different effects on blood pressure, fluid balance, and vascular function compared with native ANP.

Other: Infusion of two different cardiac peptides plus vehicle

Placebo (Saline)

PLACEBO COMPARATOR

Participants receive an intravenous infusion of isotonic saline at a low, weight-adjusted rate. This arm serves as a placebo control to account for the effects of the infusion procedure, time, and study conditions. The volume administered is equal to both of the active days. All measurements and observations are identical to those performed during the active intervention arms.

Other: Infusion of two different cardiac peptides plus vehicle

Interventions

Infusion of two different cardiac peptides plus vehicle OTHER

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

Atrial Natriuretic Peptide (ANP) - a well described cardiac hormone; Glycosylated Atrial Natriuretic Peptide (gANP) - a naturally occurring modified cardiac hormone; Placebo (Saline)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers
• Age: 18-30 years
• BMI: 20-25 kg/m²
• Body weight ≤90 kg (amended protocol)
• Normal hemoglobin
• Ability to provide informed consent

You may not qualify if:

• Acute illness within two weeks
• Chronic cardiovascular, renal, hepatic, pulmonary, metabolic or malignant disease
• Hypotension or history of syncope
• Smoking
• Substance or alcohol abuse
• Recent blood donation (\<3 months)
• Medication that cannot be safely interrupted

Sponsors & Collaborators

• Peter Fruergaard Andersen: lead
• Region Hovedstadens Apotek: collaborator
• Rigshospitalet, Denmark: collaborator
• University Hospital Bispebjerg and Frederiksberg: collaborator

Study Sites (1)

4) Department of Clinical Pharmacology, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Heart Failure; Hypertension; Renal Insufficiency; Atrial Fibrillation, Familial, 6

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Katrine T-B Schjoldager, Associate Professor

  Department of Cellular and Molecular Medicine, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: This randomized, double blinded, placebo controlled, crossover study investigates the physiological effects of intravenous glycosylated ANP compared with naked ANP and saline in healthy male volunteers, with particular focus on blood pressure regulation, diuresis, natriuresis, and vascular function.

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 26, 2026
• Study Start: May 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)