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

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ClinicalTrials.gov Identifier: NCT02914652
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Ventricular Septal Defect Drug: Salbutamol Drug: Norflouran (Placebo Evohaler(R) ) Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Cardiopulmonary Effect of Inhaled Beta-2-agonists on Adult Ventrucular Septal Defect Patients With Persistant or Surgically Corrected Conditions - The VENTI Trial
Actual Study Start Date : October 15, 2016
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : January 1, 2018


Arm Intervention/treatment
Experimental: Operated VSD's
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
Ventoline(R), inhalation spray, 0,1 mg/dose, 9 doses administered as coherent single doses.
Other Name: Ventoline

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

Experimental: Un-operated VSD's
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
Ventoline(R), inhalation spray, 0,1 mg/dose, 9 doses administered as coherent single doses.
Other Name: Ventoline

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

Experimental: Healthy controls
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
Ventoline(R), inhalation spray, 0,1 mg/dose, 9 doses administered as coherent single doses.
Other Name: Ventoline

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




Primary Outcome Measures :
  1. Minute Ventilation (ml/min) in VSD-operated patientes [ Time Frame: 21 to 26 years after surgical closure. ]
  2. Peek Exercise Oxygen Uptake (ml O2/kg/min) in VSD-operated patientes [ Time Frame: 21 to 26 years after surgical closure. ]
  3. Maximal workload (W) in VSD-operated patientes. [ Time Frame: 21 to 26 years after surgical closure. ]

Secondary Outcome Measures :
  1. Peak heart rate at maximal exercise, in VSD-operated patients. [ Time Frame: Twentyone to 26 years after surgical closure. ]
  2. Forced expiratory volume in 1 second (FEV1), in VSD-operated patients. [ Time Frame: 21 to 26 years after surgical closure. ]
  3. Airway resistance (R5-R20), in VSD-operated patients. [ Time Frame: 21 to 26 years after surgical closure. ]
  4. Hear-rate variability, in VSD-operated patients. [ Time Frame: 21 to 26 years after surgical closure. ]
  5. Diffusion capacity (DLCO), in VSD-operated patients. [ Time Frame: 21 to 26 years after surgical closure. ]
  6. Alveolar volume, in VSD-operated patients. [ Time Frame: 21 to 26 years after surgical closure. ]
  7. Lung clearance index, in VSD-operated patients. [ Time Frame: 21 to 26 years after surgical closure. ]


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Ages Eligible for Study:   21 Years to 26 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ≥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.
  • Restrain from strenuous leg exercise 24 hours before inclusion.

Exclusion Criteria:

  • 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

The product summary was used to establish exclusion criteria in regards to medication and diseases that aren't eligible with the medical treatment. Other medication than described in the in- and exclusion criteria will be noted in the participants CRF. If the participant takes any special medication one of our trial doctors will determine if the participant should be excluded.

Participants will be informed of the exclusion criteria in the information letter and at the initial information interview before inclusion in the trial. Oral verification is considered sufficient to verify the exclusion criteria.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914652


Locations
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Denmark
Dept. of Cardiothoracic and Vascular Surgery
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Vibeke E Hjortdal, MD PhD DMSc Dept. of Cardiothoracic & Vascular Surgery, Aarhus University Hospital, Skejby

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02914652     History of Changes
Other Study ID Numbers: CERCA5
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by University of Aarhus:
Congenital Heart Disease
Ventricular Septal Defect
Beta-2-agonists
Surgery
Follow-up
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action