Heart FailureX-HF-SPECKLENCT01747785
Myocardial Performance at Rest and During Exercise in Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to study how well the heart contracts and relaxes during exercise. In addition to traditional measures of heart function, we will use a new computer program that may improve understanding of why people feel shortness of breath or fatigue. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiac rehabilitation, Myocardial deformation imaging and Cardiopulmonary exercise test
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jul 2015
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- 18 years of age or older,
- able to exercise on a bicycle
Who cannot join
- heart arrhythmias,
- severe chronic obstructive pulmonary disease,
- congenital heart abnormalities,
- infiltrative or hypertrophic cardiomyopathy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Health System - Franciscan Healthcare
La Crosse, Wisconsin, 54601
About this study
Official title: Myocardial Performance at Rest and During Exercise in Heart Failure With Preserved Ejection Fraction: Speckle Tracking Echocardiography - One Piece of the Puzzle.
This study is being done to study how well the heart contracts and relaxes during exercise. In addition to traditional measures of heart function, we will use a new computer program that may improve understanding of why people feel shortness of breath or fatigue.
Read the detailed description
Heart failure with preserved ejection fraction is not well understood, although account for nearly half of all heart failure cases. This study aims to collect data about systolic (contracting portion of a heart beat) and diastolic (relaxing portion of a heart beat) dysfunction at rest and during exercise. Participants with normal cardiac function will serve as a control group and compared to participants who are at risk of heart failure.
- Conditions
- Heart Failure
- Being tested
- Cardiac rehabilitation, Myocardial deformation imaging, Cardiopulmonary exercise test
- Keywords
- Heart failure, HFpEF, Dyspnea, Fatigue, Shortness of Breath, exercise, strain, myocardial deformation, cardiac rehabilitation, cardiac hemodynamics
- Medical subject headings
- Heart Failure, Dyspnea, Fatigue, Motor Activity, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationOther
Aerobic cardiac exercise training will be provided over the 12 week study duration.
Myocardial deformation imagingOther
A 2D Doppler echocardiograph (image) of the heart will be captured during a single heart beat taken at rest and during cardiopulmonary exercise tests to measure left and right ventricular segmental systolic and diastolic strain measurements.
Cardiopulmonary exercise testOther
The cardiopulmonary exercise test consists of cycling exercise of mild and moderate intensity on an upright cycle ergometer on a tilting table (to facilitate imaging) for 6-10 minute periods within a one hour session.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Individuals without history of cardiovascular disease and at least 18 years of age will take a baseline (at rest) cardiopulmonary exercise test (CPX) and have a cardiac echocardiogram to measure myocardial deformation. CPX and echocardiograms will be repeated during exercise sessions at 3 visits over a 12 week period. Receives: Other: Myocardial deformation imaging; Other: Cardiopulmonary exercise test | |
| Patients at risk of heart failure | Individuals at risk of heart failure and a preserved ejection fraction of at least 50% will take a baseline (at rest) cardiopulmonary exercise test (CPX) and have a baseline cardiac echocardiogram to measure myocardial deformation. CPX and echocardiograms will be repeated during exercise sessions at 6 visits over a 12 week period. A cardiac rehabilitation exercise program will also occur over 12 weeks. Receives: Other: Cardiac rehabilitation; Other: Myocardial deformation imaging; Other: Cardiopulmonary exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean cardiac reserve as measured by strain rate
Myocardial deformation imaging (e.g. strain, strain rate, torsion) requires clear 2-dimensional echocardiography images that will be obtain at rest and during mild and moderate intensity exercise. Images will be captured during 6-10 minute bouts of exercise on a tilting exercise table. Comparisons will be made on resting and exercise values between groups. Our hypothesis is that strain rate will not increase in patients at risk of heart failure demonstrating lack of cardiovascular reserve.
Measured: Baseline, 12 weeks
Secondary outcomes (1)
Change in mean cardiac stroke volume
Stroke volume is the volume of blood (in milliliters) ejected during each heart contraction, It is measured by combined Doppler and 2-dimensional echocardiography. A surrogate measure of stroke volume (oxygen-pulse) can also be obtained during cardiopulmonary exercise testing by dividing the measured oxygen consumption by the heart rate. Our hypothesis is that stroke volume will plateau early after exercise onset in patients at risk of heart failure and this plateau will correlate with a reduction in strain rate.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Study stopped for administrative reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hector R. Villarraga, M.D., Mayo Clinic
- Investigators
- Hector Villarraga, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747785
- Sponsor's protocol ID
- 12-005553
- Acronym
- X-HF-SPECKLE
- Status last verified
- Jan 2016
- First submitted
- 7 Dec 2012
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Performance at Rest and During Exercise in Heart Failure With Preserved Ejection Fraction: Speckle Tracking Echocardiography - One Piece of the Puzzle.
- ClinicalTrials.gov ID
- NCT01747785
- Acronym / sponsor ID
- X-HF-SPECKLE / 12-005553
- Conditions
- Heart Failure
- Keywords
- Heart failure, HFpEF, Dyspnea, Fatigue, Shortness of Breath, exercise, strain, myocardial deformation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study stopped for administrative reasons.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 Dec 2012 (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.
This study is being done to study how well the heart contracts and relaxes during exercise. In addition to traditional measures of heart function, we will use a new computer program that may improve understanding of why people feel shortness of breath or fatigue.
Detailed description
Heart failure with preserved ejection fraction is not well understood, although account for nearly half of all heart failure cases. This study aims to collect data about systolic (contracting portion of a heart beat) and diastolic (relaxing portion of a heart beat) dysfunction at rest and during exercise. Participants with normal cardiac function will serve as a control group and compared to participants who are at risk of heart failure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Other: Myocardial deformation imaging, Other: Cardiopulmonary exercise testIndividuals without history of cardiovascular disease and at least 18 years of age will take a baseline (at rest) cardiopulmonary exercise test (CPX) and have a cardiac echocardiogram to measure myocardial deformation. CPX and echocardiograms will be repeated during exercise sessions at 3 visits over a 12 week period. |
| Patients at risk of heart failure | – | Other: Cardiac rehabilitation, Other: Myocardial deformation imaging, Other: Cardiopulmonary exercise testIndividuals at risk of heart failure and a preserved ejection fraction of at least 50% will take a baseline (at rest) cardiopulmonary exercise test (CPX) and have a baseline cardiac echocardiogram to measure myocardial deformation. CPX and echocardiograms will be repeated during exercise sessions at 6 visits over a 12 week period. A cardiac rehabilitation exercise program will also occur over 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (2 listed)
- 18 years of age or older,
- able to exercise on a bicycle
Key exclusion criteria (4 listed)
- heart arrhythmias,
- severe chronic obstructive pulmonary disease,
- congenital heart abnormalities,
- infiltrative or hypertrophic cardiomyopathy.
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 |
|---|---|---|
| Cardiac rehabilitationAerobic cardiac exercise training will be provided over the 12 week study duration. | Other | Patients at risk of heart failure |
| Myocardial deformation imagingA 2D Doppler echocardiograph (image) of the heart will be captured during a single heart beat taken at rest and during cardiopulmonary exercise tests to measure left and right ventricular segmental systolic and diastolic strain measurements. | Other | Healthy controls, Patients at risk of heart failure |
| Cardiopulmonary exercise testThe cardiopulmonary exercise test consists of cycling exercise of mild and moderate intensity on an upright cycle ergometer on a tilting table (to facilitate imaging) for 6-10 minute periods within a one hour session. | Other | Healthy controls, Patients at risk of heart failure |
Primary outcome
Change in mean cardiac reserve as measured by strain rate
Time frame: Baseline, 12 weeks
Myocardial deformation imaging (e.g. strain, strain rate, torsion) requires clear 2-dimensional echocardiography images that will be obtain at rest and during mild and moderate intensity exercise. Images will be captured during 6-10 minute bouts of exercise on a tilting exercise table. Comparisons will be made on resting and exercise values between groups. Our hypothesis is that strain rate will not increase in patients at risk of heart failure demonstrating lack of cardiovascular reserve.
1 secondary outcome
Change in mean cardiac stroke volume
Time frame: Baseline, 12 weeks
Results and safety
The study was stopped early (reason given: Study stopped for administrative reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Individual participant dataSharing planned: No
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Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure
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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.
Hector Villarraga, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Mayo Clinic at 1 site in United States.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 17 May 2016. 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 United States. 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 was stopped early (reason given: Study stopped for administrative reasons.). Results are not available in the source record.
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 mean cardiac reserve as measured by strain rate (time frame: Baseline, 12 weeks). 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 17 May 2016.