NCT04956952

Brief Summary

The purpose of the proposed study is to determine the safety of enhanced external counterpulsation (EECP), a system for compressing the blood vessels in the legs in synchrony with an individual's cardiac rhythm, in clinically well, adult Fontan patients, to document the acute hemodynamic and myocardial effects of EECP on the Fontan circulation, and to demonstrate acute changes in endothelial function after one hour of the procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

March 31, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

June 1, 2021

Last Update Submit

June 10, 2023

Conditions

Single-ventricleCongenital Heart Disease

Keywords

Fontan

Outcome Measures

Primary Outcomes (3)

  • Change in cardiac output

    Measurement of cardiac output (pulmonary blood flow) in L/min using inert gas rebreathing method (Innocor CO device)

    Immediately prior to starting EECP treatment, during each 20-minute phase of EECP treatment, and 30 minutes after EECP treatment

  • Total number and type of adverse events during EECP treatment

    Adverse events will be collected by an investigator and documented using CTCAE criteria

    During EECP treatment (duration 60 minutes)

  • Total number and type of adverse events immediately following EECP treatment

    Adverse events will be collected by an investigator and documented using CTCAE criteria

    From completion of EECP treatment until patient discharge (30 to 60 minutes)

Secondary Outcomes (4)

  • Change in ventricular strain analysis

    Immediately prior to starting EECP treatment, during each 20-minute phase of EECP treatment, and 30 minutes after EECP treatment

  • Change in qualitative ventricular systolic function

    Immediately prior to starting EECP treatment, during each 20-minute phase of EECP treatment, and 30 minutes after EECP treatment

  • plasma endothelin (ET-1)

    pre and 30 minutes post EECP treatment

  • Total nitrate/nitrite (NOx) levels

    pre and 30 minutes post EECP treatment

Study Arms (1)

Enhanced External Counterpulsation (EECP)

OTHER

1 hour of treatment with EECP

Device: EECP

Interventions

EECPDEVICE

1 hour of treatment with EECP

Enhanced External Counterpulsation (EECP)

Eligibility Criteria

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

You may qualify if:

  • Individuals with Fontan physiology being seen in the Boston Children's Hospital cardiology clinic for outpatient care.

You may not qualify if:

  • Current pregnancy
  • Decompensated heart failure/pulmonary edema
  • Severe aortic insufficiency
  • Active tachyarrhythmias
  • Frequent atrial or ventricular ectopy
  • Symptomatic peripheral vascular disease
  • Thrombophlebitis or history of deep vein thrombosis or stasis ulcer
  • Aortic aneurysm
  • Uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure\>110 mmHg)
  • Systolic blood pressure \<90 mmHg
  • Active femoral site bleeding or hematoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Univentricular HeartHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Fred Wu, MD

    Attending Cardiologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2021

First Posted

July 9, 2021

Study Start

March 31, 2022

Primary Completion

May 17, 2023

Study Completion

May 17, 2023

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)