Right-heart HemodynamicsNCT02054728
Inspiratory Muscle Training During Right-heart Catheterization
A study testing RHC and IMT in people with Right-heart Hemodynamics and Respiratory Muscle Training, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
Trial summary
The purpose of this study is to assess hemodynamic effects of inspiratory muscle training during routinely performed right-heart catheterization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right-heart Hemodynamics, Respiratory Muscle Training, Inspiratory Resistance
- What is being tested?
- RHC and IMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 16 Oct 2012to 1 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Indication for right-heart catheterization
- Informed Consent provided
Who cannot join
- Age < 18 years
- Inability or contraindication to undergo right-heart catheterization
- Inability or contraindication to undergo respiratory muscle training as required per protocol
- Pregnancy, lactation
- Any medical, psychological or other condition restricting the patient's ability to provide informed consent
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine
Solingen, North Rhine-Westphalia, 42699
About this study
The purpose of this study is to assess hemodynamic effects of inspiratory muscle training during routinely performed right-heart catheterization.
Read the detailed description
During the last years, respiratory muscle training (RMT) in patients with impaired respiratory muscle function, e.g. in chronic obstructive pulmonary disease (COPD), is increasingly applied. RMT can be done by applying increased respiratory effort for several minutes via an apparatus providing an inspiratory stenosis. Threshold IMT® (Philips Respironics) for example is such a training device, which is in the market for several years now and which has been used to conduct studies applying RMT. For example, it has been shown that training with the Threshold IMT® in patients with COPD increases inspiratory muscle strength, endurance and functional capacity and ameliorates dyspnea and quality of life. Furthermore, patients suffering from cardiac illness can also be affected by respiratory muscle impairment, which can add to their cardiogenic dyspnea. RMT can help improve dyspnea and physical exercise capacity in those patients as well.
To date, no studies have been performed addressing acute hemodynamic effects of inspiratory muscle training. However, this is of special interest: COPD as well as heart failure patients show an increased prevalence of pulmonary hypertension.
In case of suspected pulmonary hypertension, patients usually are subjected to right-heart catheterization (RHC) to arrive at a definitive diagnosis and assess severity and etiology of potentially present pulmonary hypertension. RHC is also a sensitive method to exclude an intracardial shunt in COPD patients.
In this study, patients who are routinely subjected to RHC for the above mentioned reasons will be instructed to do RMT using the Threshold IMT® during RHC. Two days in advance they will begin a guided training to get familiar with the Threshold IMT®. The device's inspiratory resistance can be set between 9 and 41 cm H2O. A single training session consists of 7 cycles with 2 min inspiratory training each, followed by a 1 min break (total duration 21 min). RMT will be conducted with 20-30% of individual inspiratory muscle strength, which will be measured beforehand.
During the RHC procedure the patients will again conduct RMT as instructed while the suspected hemodynamic effects will be documented.
- Being tested
- RHC and IMT
- Keywords
- right-heart catheterization, respiratory muscle training, inspiratory resistance, hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RHC and IMTOther
Eligible patients subjected to RHC will be instructed on how to do RMT using the Threshold IMT® two days in advance. RMT will be conducted with 20-30% of individual inspiratory muscle strength, which will be measured beforehand. A single training session consists of 7 cycles with 2 min inspiratory training each, followed by a 1 min break (total duration 21 min).
The actual intervention consists of inspiratory muscle training (IMT) during right-heart catheterization for at least 2 min or as long as is necessary to measure all specified parameters.
| Study group | Role | What they receive |
|---|---|---|
| RHC and IMT | Experimental | Not described Receives: Other: RHC and IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pulmonary arterial pressure
Pulmonary arterial pressure will be measured during RHC with and without parallel Inspiratory Muscle Training (IMT). Changes related to IMT will be assessed.
Measured: During RHC with and without parallel IMT
Secondary outcomes (5)
Change in Pulmonary Capillary Wedge Pressure
Measured: During RHC with and without parallel IMT
Change in Cardiac output
Measured: During RHC with and without parallel IMT
Change in Cardiac index
Measured: During RHC with and without parallel IMT
Change in Stroke volume index
Measured: During RHC with and without parallel IMT
Change in Stroke volume
Measured: During RHC with and without parallel IMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study start16 Oct 2012
- Primary completion1 Dec 2014
- Study completion1 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right-heart HemodynamicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054728
- Sponsor's protocol ID
- WI_IMT_RHK_82/2012
- Status last verified
- Oct 2018
- First submitted
- 20 Dec 2012
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training During Right-heart Catheterization
- ClinicalTrials.gov ID
- NCT02054728
- Acronym / sponsor ID
- WI_IMT_RHK_82/2012
- Keywords
- right-heart catheterization, respiratory muscle training, inspiratory resistance, hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Study start
- 16 Oct 2012 (actual)
- Primary completion
- 1 Dec 2014 (actual)
- Study completion
- 1 Dec 2014 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess hemodynamic effects of inspiratory muscle training during routinely performed right-heart catheterization.
Detailed description
During the last years, respiratory muscle training (RMT) in patients with impaired respiratory muscle function, e.g. in chronic obstructive pulmonary disease (COPD), is increasingly applied. RMT can be done by applying increased respiratory effort for several minutes via an apparatus providing an inspiratory stenosis. Threshold IMT® (Philips Respironics) for example is such a training device, which is in the market for several years now and which has been used to conduct studies applying RMT. For example, it has been shown that training with the Threshold IMT® in patients with COPD increases inspiratory muscle strength, endurance and functional capacity and ameliorates dyspnea and quality of life. Furthermore, patients suffering from cardiac illness can also be affected by respiratory muscle impairment, which can add to their cardiogenic dyspnea. RMT can help improve dyspnea and physical exercise capacity in those patients as well.
To date, no studies have been performed addressing acute hemodynamic effects of inspiratory muscle training. However, this is of special interest: COPD as well as heart failure patients show an increased prevalence of pulmonary hypertension.
In case of suspected pulmonary hypertension, patients usually are subjected to right-heart catheterization (RHC) to arrive at a definitive diagnosis and assess severity and etiology of potentially present pulmonary hypertension. RHC is also a sensitive method to exclude an intracardial shunt in COPD patients.
In this study, patients who are routinely subjected to RHC for the above mentioned reasons will be instructed to do RMT using the Threshold IMT® during RHC. Two days in advance they will begin a guided training to get familiar with the Threshold IMT®. The device's inspiratory resistance can be set between 9 and 41 cm H2O. A single training session consists of 7 cycles with 2 min inspiratory training each, followed by a 1 min break (total duration 21 min). RMT will be conducted with 20-30% of individual inspiratory muscle strength, which will be measured beforehand.
During the RHC procedure the patients will again conduct RMT as instructed while the suspected hemodynamic effects will be documented.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RHC and IMT | Experimental | Other: RHC and IMT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Indication for right-heart catheterization
- Informed Consent provided
Key exclusion criteria (6 listed)
- Age < 18 years
- Inability or contraindication to undergo right-heart catheterization
- Inability or contraindication to undergo respiratory muscle training as required per protocol
- Pregnancy, lactation
- Any medical, psychological or other condition restricting the patient's ability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RHC and IMTEligible patients subjected to RHC will be instructed on how to do RMT using the Threshold IMT® two days in advance. RMT will be conducted with 20-30% of individual inspiratory muscle strength, which will be measured beforehand. A single training session consists of 7 cycles with 2 min inspiratory training each, followed by a 1 min break (total duration 21 min). The actual intervention consists of inspiratory muscle training (IMT) during right-heart catheterization for at least 2 min or as long as is necessary to measure all specified parameters. | Other | RHC and IMT |
Primary outcome
Change in Pulmonary arterial pressure
Time frame: During RHC with and without parallel IMT
Pulmonary arterial pressure will be measured during RHC with and without parallel Inspiratory Muscle Training (IMT). Changes related to IMT will be assessed.
5 secondary outcomes
Change in Pulmonary Capillary Wedge Pressure
Time frame: During RHC with and without parallel IMT
Change in Cardiac output
Time frame: During RHC with and without parallel IMT
Change in Cardiac index
Time frame: During RHC with and without parallel IMT
Change in Stroke volume index
Time frame: During RHC with and without parallel IMT
Change in Stroke volume
Time frame: During RHC with and without parallel IMT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RHC and IMT in people with Right-heart Hemodynamics and Respiratory Muscle Training, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pulmonary arterial pressure (time frame: During RHC with and without parallel IMT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.