NCT06762964

Brief Summary

The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 3 months affects peripheral venous pressure at rest and during exercise in adults with failing Fontan circulation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
9mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
May 2025Feb 2027

First Submitted

Initial submission to the registry

January 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

May 16, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

January 2, 2025

Last Update Submit

May 5, 2026

Conditions

Fontan CirculationSingle Ventricle Heart DiseaseHFpEF - Heart Failure With Preserved Ejection Fraction

Keywords

FontanHFpEFSGLT2 inhibitors

Outcome Measures

Primary Outcomes (3)

  • Peripheral venous pressure (PVP) at rest

    Peripheral venous pressure (PVP) at rest will be determined by Stress Echocardiogram. Peripheral venous pressure (PVP) is measured in millimeters of mercury (mmHg).

    Baseline, 12 Weeks

  • Peripheral venous pressure (PVP) with feet elevated

    Peripheral venous pressure (PVP) with feet elevated will be determined by Stress Echocardiogram. Peripheral venous pressure (PVP) is measured in millimeters of mercury (mmHg).

    Baseline, 12 Weeks

  • Peripheral venous pressure (PVP) at 20W exercise

    Peripheral venous pressure (PVP) at 20W exercise will be determined by Stress Echocardiogram. Peripheral venous pressure (PVP) is measured in millimeters of mercury (mmHg).

    Baseline, 12 Weeks

Secondary Outcomes (8)

  • Cardiac output at rest

    Baseline, 12 Weeks

  • Cardiac output with exercise

    Baseline, 12 Weeks

  • Peak oxygen consumption (VO2) during exercise

    Baseline, 12 Weeks

  • Change in plasma volume

    Baseline, 12 Weeks

  • Change in blood volume

    Baseline, 12 Weeks

  • +3 more secondary outcomes

Study Arms (2)

Dapagliflozin

EXPERIMENTAL
Drug: Dapagliflozin tablet

Placebo

PLACEBO COMPARATOR
Drug: Placebo Tablet

Interventions

Dapagliflozin tabletDRUG

Patient will take a 10mg tablet of Dapagliflozin once daily for 12 weeks

Dapagliflozin
Placebo TabletDRUG

Patient will take 10mg placebo tablet once daily for 12 weeks

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent prior to any study specific procedures
  • History of Fontan procedure
  • Male or female subject
  • Age ≥ 18
  • Symptoms of dyspnea (NYHA II-IV) with no non-cardiac or ischemia explanation
  • Elevated peripheral venous pressure (PVP) at rest or during exercise (≥20 mmHg) ascertained at Visit 1. Patients that have consented to study procedures but do not meet this invasive criterion will be considered as screen failures and will not be randomized.

You may not qualify if:

  • Type I diabetes
  • Any of the following medications: Insulin or Pramlintide, Sandostatin, Akeega (abiraterone acetate), Growth Hormone (Somatogrogon-GHLA), Lithium, Chloroquine, Hydroxychloroquine, Thioctic acid (alpha lipoic acid), Empagliflozin or Canagliflozin
  • Recent hospitalization (\<30 days) or revascularization (\<90 days)
  • Significant valvular heart disease (≥moderate stenosis, \>moderate regurgitation)
  • Significant Fontan obstruction with resting SVC-IVC gradient \>4 mmHg
  • Primary cardiomyopathy (such as amyloid)
  • Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator
  • Severe anemia (hemoglobin \<9 gm/dl)
  • Severe kidney disease (estimated GFR\<30) or liver disease
  • Women of childbearing potential not willing to use a medically accepted method of contraception OR who are currently pregnant (confirmed with positive pregnancy test) or breast feeding.
  • History of serious hypersensitivity reaction to dapagliflozin
  • Subjects on dialysis
  • Subjects with severe liver disease with history of decompensation including ascites or encephalopathy or variceal bleeding
  • Single ventricle heart disease without Fontan palliation
  • Those with a history of Fontan takedown

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Interventions

dapagliflozin

Study Officials

  • Luke Burchill, M.B.B.S., Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Wozniak

CONTACT

507-266-1976Wozniak.Amanda@mayo.edu

Yusef Maarouf

CONTACT

507-422-5755Maarouf.Yusef@mayo.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 8, 2025

Study Start

May 16, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)