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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 22 October 2018
Main ID:  NCT03297918
Date of registration: 26/09/2017
Prospective Registration: Yes
Primary sponsor: University Hospital, Basel, Switzerland
Public title: Impact of a Structural Phonation Training on Respiratory Muscle Function in Patients With Structural Heart Disease
Scientific title: Impact of a Structural Phonation Training on Respiratory Muscle Function in Patients With Structural Heart Disease - HeartChoir
Date of first enrolment: February 15, 2018
Target sample size: 24
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03297918
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).  
Phase:  N/A
Countries of recruitment
Switzerland
Contacts
Name:     Daniel Tobler, MD
Address: 
Telephone:
Email:
Affiliation:  University Hospital, Basel, Switzerland
Key inclusion & exclusion criteria

Inclusion Criteria:

- Informed Consent as documented by signature (Appendix Informed Consent Form)

- age = 18 years

- known cardiomyopathy from acquired heart disease (ischemic or dilated) or patients
with complex CHD (cyanotic congenital heart disease, Fontan palliation, subaortic
right ventricle or repaired tetralogy of Fallot)

Exclusion Criteria:

- Acute coronary syndrome, cardiac surgery or heart failure hospitalization within the
previous 6 months

- chronic metabolic, orthopedic, or infectious disease; treatment with steroids,
hormones, or cancer chemotherapy

- severe exercise-induced asthma

- professional singer or professionally performing a wind instrument

- Known or suspected non-compliance, drug or alcohol abuse

- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. of the participant,



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Congenital Heart Disease
Heart Failure
Intervention(s)
Behavioral: Respiratory muscle training
Primary Outcome(s)
Maximal inspiratory pressure in kilopascal [Time Frame: 12 weeks]
Secondary Outcome(s)
Change of MEP [Time Frame: 12 wees]
Change of MVO2 [Time Frame: 12 weeks]
Change of QoL [Time Frame: 12 weeks]
NT-proBNP [Time Frame: 12 weeks]
Secondary ID(s)
HeartChoir
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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