The Cardiopulmonary Effect of Inhaled Beta-2-agonists on Adult Patients Born With Ventricular Septum Defects.

NCT02914652 | Completed Phase 4 DMC

• 1 other identifier: CERCA5
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective for this study is to test whether β2-agonists will affect the cardiopulmonary capacity of VSD-operated patients compared with un-operated VSD-patients and healthy age- and gender-matched controls.

Conditions

Ventricular Septal Defect

Keywords

Congenital Heart Disease; Ventricular Septal Defect; Beta-2-agonists; Surgery; Follow-up

Outcome Measures

Primary Outcomes (3)

• Minute Ventilation (ml/min) in VSD-operated patientes

  21 to 26 years after surgical closure.

• Peek Exercise Oxygen Uptake (ml O2/kg/min) in VSD-operated patientes

  21 to 26 years after surgical closure.

• Maximal workload (W) in VSD-operated patientes.

  21 to 26 years after surgical closure.

Secondary Outcomes (7)

• Peak heart rate at maximal exercise, in VSD-operated patients.

  Twentyone to 26 years after surgical closure.

• Forced expiratory volume in 1 second (FEV1), in VSD-operated patients.

  21 to 26 years after surgical closure.

• Airway resistance (R5-R20), in VSD-operated patients.

  21 to 26 years after surgical closure.

• Hear-rate variability, in VSD-operated patients.

  21 to 26 years after surgical closure.

• Diffusion capacity (DLCO), in VSD-operated patients.

  21 to 26 years after surgical closure.

Study Arms (3)

Operated VSD's

EXPERIMENTAL

Through the use of Electronic Patient Journal (EPJ), the investigators have identified a total of 182 children who underwent surgical closure of a congenital VSD at Aarhus University Hospital, Denmark between 1990 and 1995. After thorough review of all charts, 117 patients were excluded from participation. Exclusion criteria were coexistence of other congenital heart defects (n=89), associated syndromes, e.g. Down's (n=14), operation through a ventricular approach (n=7), missing chart (n=6) and documented arrhythmia requiring pacemaker (n=1). The remaining 68 patients represent a homogeneous group comparing surgeons, anaesthetists, surgical procedure and post-surgical period. A fraction of this group will be randomly selected for this trial, and receives salbutamol or norflouran, blinded.

Drug: Salbutamol; Drug: Norflouran (Placebo Evohaler(R) )

Un-operated VSD's

EXPERIMENTAL

Using EPJ, this project identified a total of 481 children born between 1985 and 1998 who had a small VSD, confirmed through diagnosis codes, that was not closed, neither spontaneously nor surgically. Exclusion criteria were lack of medical record, suffering from coronary disease, other congenital cardiac abnormalities than VSD, spontaneous closure of the ventricular septal defect at inclusion date, magnetic implants, pregnancy, lack of Danish language skills, suffering from lung disease requiring continuous medical treatment. The remaining patients represent a homogenous group of patients with isolated persistent ventricular septal defects. A fraction of this group will be randomly selected for this trial, and receives salbutamol or norflouran, blinded.

Drug: Salbutamol; Drug: Norflouran (Placebo Evohaler(R) )

Healthy controls

EXPERIMENTAL

Will function as a control group. Controls will be recruited through www.forsoegsperson.dk and www.sundhed.dk. Current group receives salbutamol or norflouran, blinded.

Drug: Salbutamol; Drug: Norflouran (Placebo Evohaler(R) )

Interventions

Salbutamol DRUG

Ventoline(R), inhalation spray, 0,1 mg/dose, 9 doses administered as coherent single doses.

Also known as: Ventoline

Healthy controls; Operated VSD's; Un-operated VSD's

Norflouran (Placebo Evohaler(R) ) DRUG

Placebo Evohaler(R) MDI, inhalation spray, 60 mg/dose, 9 doses administered as coherent single doses.

Also known as: Placebo

Healthy controls; Operated VSD's; Un-operated VSD's

Eligibility Criteria

• Age: 21 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ≥18 years of age and legally competent to vouch for their own study participation.
• Informed and written consent for participation in this trial.
• Trial group 1: Surgically corrected for isolated VSD between 1990 and 1998 at Aarhus University Hospital.
• Trial group 2: Diagnosed with isolated VSD born between 1985 and 1998 without surgical or percutaneous closure. Verified by Echocardiography within the last 4 years. If it is more than 4 it will be verified by our doctors as a systolic murmur or echocardiography.
• Trial group 3: 18-30 years, with no known medical records of heart and lung disease.

You may not qualify if:

• Lack of medical record.
• Pregnancy.
• o Participants will be asked if they are using contraceptives and be told to continue this during the trial and for at least 30 hours (5 times T2) after their last visit. If they are not using spiral or valid contraceptives (contraceptive pills, implants, transdermal patches, vaginal ring or injections) one of our medical experts will judge if the participant is able to undergo the trial. They will likewise be informed to withstand from sexual intercourse during the trial until 30 hours after the second visit.
• Currently breastfeeding.
• Syndromes, such as Down's.
• Mentally or physically incompetent to perform the ergometer bicycle test.
• Thyrotoxicosis.
• Pre-trial medical record of arrhythmias except right bundle branch block.
• Asthma or other known β2-responsive conditions.
• Coronary heart disease.
• Severe pulmonary disease.
• Diabetes.
• Use of the following medication: Xantin-derivates, steroids, diuretics, ipratropium.
• Allergy to the active ingredients of Ventoline: Salbutamolsulphate, benzalkoniumchloride

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Dept. of Cardiothoracic and Vascular Surgery

Aarhus, 8000, Denmark

Location

Related Publications (31)

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MeSH Terms

Conditions

Heart Septal Defects, Ventricular; Heart Defects, Congenital

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Heart Septal Defects; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Vibeke E Hjortdal, MD PhD DMSc

  Dept. of Cardiothoracic & Vascular Surgery, Aarhus University Hospital, Skejby

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 26, 2016
• Study Start: October 15, 2016
• Primary Completion: July 1, 2017
• Study Completion: January 1, 2018
• Last Updated: July 5, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)