Diastolic DysfunctionNCT00998114
Early Detection of Diastolic Dysfunction and the Role of Lifestyle Measures in Its Treatment
A study testing Exercise in people with Diastolic Dysfunction, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The project aims to investigate the effect of a regular exercise for 6 months on diastolic parameters in patients who present with shortness of breath and who have evidence of early diastolic dysfunction on echocardiography. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diastolic Dysfunction
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to May 2011
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with dyspnea/shortness of breath
- Age 40-65 years of age
- Sedentary lifestyle (<150 minutes of exercise/week)
- Echocardiographic evidence of early diastolic dysfunction: mitral E/A <0.9, OR resting E/E' between 8-15 cm/s, OR post-exercise E/E' >13 cm/s.
Who cannot join
- Age <40 years or >65 years
- Coronary Artery Disease by angiography or evidence of ischemia on a stress test
- Systolic Dysfunction (LV Ejection fraction <50%)
- Congestive Heart Failure Functional Class III or IV
- Moderate to severe COPD (FEV <80% predicted)
- Moderate to severe valvular heart disease, except tricuspid regurgitation
Show all 10Show fewer
- Inability to get heart rate >/= 85% of maximum predicted heart rate
- Uncontrolled hypertension (systolic BP>140mmHg, diastolic BP>90mmHg) despite medical therapy
- On echocardiogram, RV systolic pressure >60mmHg that suggests severe pulmonary hypertension
- On echocardiogram, left atrial size> 6.5 cm or left atrial volume > 35 ml/BSA
Trial locations and contacts
1 site in 1 country.
United States1 site
Harry S Truman Veterans Administration Hospital
Columbia, Missouri, 65201
About this study
The project aims to investigate the effect of a regular exercise for 6 months on diastolic parameters in patients who present with shortness of breath and who have evidence of early diastolic dysfunction on echocardiography. Patients will be enrolled from the VA General Medicine and Cardiology Clinics, and will be screened for diastolic dysfunction. Once enrolled, they will be on an exercise regimen that involves aerobic exercise for 30-45 minutes five times a week at home. The participants will have an initial supervised exercise session with the VA Cardiac Rehabilitation team, and will have either every other week or monthly supervised sessions at the VA Cardiac Rehabilitation Center to monitor their progress. Clinical, biometric, laboratory and echocardiographic parameters will be obtained before and after the 6 month period.
Read the detailed description
Introduction:
Diastolic dysfunction (DD) accounts for >50% of all heart failure (DHF) hospitalizations and this number is increasing with age, obesity and diabetes.
There are no proven treatments for DHF apart from blood pressure control.
Aim:
If diagnosed early, is this reversible with lifestyle changes; namely, aerobic exercise and weight reduction?
Methods:
We will screen veterans presenting to the medicine, cardiology and pulmonary services with dyspnea. We will perform echocardiography with Doppler which non-invasively measures cardiac filling and diastolic dysfunction. Treadmill exercise echo will be performed to quantify DD.
Bruce treadmill protocol description/ procedure: Exercise is performed on a treadmill. The test starts at 2.74 km/hr (1.7 mph) and at a gradient (or incline) of 10%. At three minute intervals the incline of the treadmill increases by 2%, and the speed increases as shown in the table below.
Stage Speed (mph) Gradient:
- 1.7 10
- 2.5 12
- 3.4 14
- 4.2 16
- 5.0 18
- 5.5 20
- 6.0 22
- 6.5 24
- 7.0 26
- 7.5 28
Subject exercise study:
For physical exercise to have a beneficial effect on cardiac function, we suggest the following:
- Type of Exercise
- Walking - outdoors or treadmill
- Running or jogging
- Cycling - outdoors or stationary
Duration of Exercise:
Initial 2-3 minute gradual warm-up period. Roughly 30 minutes of continuous exercise 5 times a week.
Finally a few minutes of gradual cool-down before terminating exercise.
Intensity of Exercise:
Target exercise at a "moderately significant exertion".
We will demonstrate what is adequate in the beginning and periodically throughout the 6 months of the study.
"Maximum age predicted heart rate (MPHR)" is calculated as 220 minus subject's age. Then we would like to sustain roughly about 70 to 85% of MPHR for 25-30 minutes.
"Successful" Exerciser: Subjects who are able to adhere to the required intensity and duration of exercise for the majority (about 75% or more) of the time; averaging 150 minutes/ week on self reporting.
- Conditions
- Diastolic Dysfunction
- Being tested
- Exercise
- Keywords
- Early Cardiac Diastolic Dysfunction, Aerobic Exercise, Weight Reduction
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Diastolic Dysfunction
Aerobic exercise for 30-45 minutes five times a week for six months
| Study group | Role | What they receive |
|---|---|---|
| Exercise and diastolic dysfunction | Experimental | Aerobic exercise for 30-45 minutes five times a week for six months Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise echo Doppler will be done at baseline and after completion of 6 months of an exercise program
Measured: Beginning of study participation and after 6 months of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startJun 2008
- Primary completionMay 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic DysfunctionStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anand Chockalingam, University of Missouri-Columbia
- Investigators
- Anand Chockalingam, MD, Principal investigator, University of Missouri/Harry S Truman VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998114
- Sponsor's protocol ID
- 1115737
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2009
- Last updated
- 5 Oct 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 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Diastolic Dysfunction and the Role of Lifestyle Measures in Its Treatment
- ClinicalTrials.gov ID
- NCT00998114
- Acronym / sponsor ID
- 1115737
- Conditions
- Diastolic Dysfunction
- Keywords
- Early Cardiac Diastolic Dysfunction, Aerobic Exercise, Weight Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 20 Oct 2009 (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 project aims to investigate the effect of a regular exercise for 6 months on diastolic parameters in patients who present with shortness of breath and who have evidence of early diastolic dysfunction on echocardiography. Patients will be enrolled from the VA General Medicine and Cardiology Clinics, and will be screened for diastolic dysfunction. Once enrolled, they will be on an exercise regimen that involves aerobic exercise for 30-45 minutes five times a week at home. The participants will have an initial supervised exercise session with the VA Cardiac Rehabilitation team, and will have either every other week or monthly supervised sessions at the VA Cardiac Rehabilitation Center to monitor their progress. Clinical, biometric, laboratory and echocardiographic parameters will be obtained before and after the 6 month period.
Detailed description
Introduction:
Diastolic dysfunction (DD) accounts for >50% of all heart failure (DHF) hospitalizations and this number is increasing with age, obesity and diabetes.
There are no proven treatments for DHF apart from blood pressure control.
Aim:
If diagnosed early, is this reversible with lifestyle changes; namely, aerobic exercise and weight reduction?
Methods:
We will screen veterans presenting to the medicine, cardiology and pulmonary services with dyspnea. We will perform echocardiography with Doppler which non-invasively measures cardiac filling and diastolic dysfunction. Treadmill exercise echo will be performed to quantify DD.
Bruce treadmill protocol description/ procedure: Exercise is performed on a treadmill. The test starts at 2.74 km/hr (1.7 mph) and at a gradient (or incline) of 10%. At three minute intervals the incline of the treadmill increases by 2%, and the speed increases as shown in the table below.
Stage Speed (mph) Gradient:
- 1.7 10
- 2.5 12
- 3.4 14
- 4.2 16
- 5.0 18
- 5.5 20
- 6.0 22
- 6.5 24
- 7.0 26
- 7.5 28
Subject exercise study:
For physical exercise to have a beneficial effect on cardiac function, we suggest the following:
- Type of Exercise
- Walking - outdoors or treadmill
- Running or jogging
- Cycling - outdoors or stationary
Duration of Exercise:
Initial 2-3 minute gradual warm-up period. Roughly 30 minutes of continuous exercise 5 times a week.
Finally a few minutes of gradual cool-down before terminating exercise.
Intensity of Exercise:
Target exercise at a "moderately significant exertion".
We will demonstrate what is adequate in the beginning and periodically throughout the 6 months of the study.
"Maximum age predicted heart rate (MPHR)" is calculated as 220 minus subject's age. Then we would like to sustain roughly about 70 to 85% of MPHR for 25-30 minutes.
"Successful" Exerciser: Subjects who are able to adhere to the required intensity and duration of exercise for the majority (about 75% or more) of the time; averaging 150 minutes/ week on self reporting.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise and diastolic dysfunction | Experimental | Behavioral: ExerciseAerobic exercise for 30-45 minutes five times a week for six months |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with dyspnea/shortness of breath
- Age 40-65 years of age
- Sedentary lifestyle (<150 minutes of exercise/week)
- Echocardiographic evidence of early diastolic dysfunction: mitral E/A <0.9, OR resting E/E' between 8-15 cm/s, OR post-exercise E/E' >13 cm/s.
Key exclusion criteria (10 listed)
- Age <40 years or >65 years
- Coronary Artery Disease by angiography or evidence of ischemia on a stress test
- Systolic Dysfunction (LV Ejection fraction <50%)
- Congestive Heart Failure Functional Class III or IV
- Moderate to severe COPD (FEV <80% predicted)
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 |
|---|---|---|
| ExerciseAlso: Diastolic DysfunctionAerobic exercise for 30-45 minutes five times a week for six months | Behavioural | Exercise and diastolic dysfunction |
Primary outcome
Exercise echo Doppler will be done at baseline and after completion of 6 months of an exercise program
Time frame: Beginning of study participation and after 6 months of study participation
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 5 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Anand Chockalingam, MD principal investigator
University of Missouri/Harry S Truman VA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Diastolic Dysfunction, run by University of Missouri-Columbia 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 4 inclusion and 10 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 5 Oct 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 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?
Exercise echo Doppler will be done at baseline and after completion of 6 months of an exercise program (time frame: Beginning of study participation and after 6 months of study participation). 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 5 Oct 2016.