Heart Failure, CongestiveNCT00125476
Effects of Exercise Training on Diastolic Heart Function in Postmenopausal Women
A study testing Exercise in people with Heart Failure, Congestive and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
This study is a prospective follow-up study to the Dose-Response to Exercise in Women (DREW) study. In DREW, 450 overweight, sedentary postmenopausal women were randomly assigned to either a non-exercise control group or to 1 of 3 weekly physical activity groups. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Heart Failure, Congestive, Cardiovascular Diseases
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to not given
- 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 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physically inactive for 6 months prior to study entry; defined as sedentary and having an energy expenditure of less than 35 kcal(kgˉ¹)(dayˉ¹)
- Postmenopausal and fits one of the following criteria: over 55 years old and no natural menses for at least 5 years; less than 55 years old and no natural menses for at least 2 years and a serum follicle stimulating hormone (FSH) level greater than 40 mIU/ml; hysterectomy with documentation of bilateral oophorectomy; less than 55 years old with a hysterectomy but no documentation of bilateral oophorectomy and with an FSH level greater than 40 mIU/ml and estradiol level less than 25 pg/ml
- If taking hormone replacement therapy, must have been on a stable dose for at least 6 months, and must maintain the same dosage of the same medication throughout the study
- Body mass index between 25 and 40 kg/m²
- Systolic blood pressure between 120 and 159 mm Hg and diastolic blood pressure no greater than 99 mm Hg
- Fasting plasma glucose level less than 126 mg/dl
- Physically capable of exercise
Who cannot join
- Currently taking any antihypertensive medications
- Current or history of significant cardiovascular diseases or disorders, including arrythmias; myocarditis; cardiomyopathy; congestive heart failure; stroke or transient ischemic cerebral attacks; peripheral vascular disease with intermittent claudication; acute, chronic, or recurrent thrombophlebitis; and Stage II or III hypertension
- Current or history of total cholesterol level of at least 240 mg/dl with LDL-C level of at least 160 mg/dl or triglyceride levels of at least 300 mg/dl
- Current or history of hematologic disorders, including anemias, bleeding disorders, chronic thrombotic disorders, or hypercoagulable states
- Recent blood donation within the 6 weeks before study entry (participants also will be asked to refrain from blood donation during the study)
- Weight loss of 20 or more kilograms within the year prior to study entry
Show all 9Show fewer
- Hospitalization for mental illness within 5 years of study entry or score of at least 10 on the Center for Epidemiological Studies Depression scale (CESD)
- Plans to be out of the city for more than 4 weeks over the next 6 months
- Other significant medical conditions, including the following: chronic or recurrent respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric conditions; musculoskeletal problems interfering with exercise; autoimmune or collagen vascular diseases; immunodeficiency diseases or a positive HIV test; malignancies within 5 years of study entry, with the exception of skin cancer that is therapeutically controlled; endocrine and metabolic disorders; or any other medical condition or disease that is life-threatening or that may interfere with or be aggravated by exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Training and Diastolic Function in Postmenopausal Women
This study is a prospective follow-up study to the Dose-Response to Exercise in Women (DREW) study. In DREW, 450 overweight, sedentary postmenopausal women were randomly assigned to either a non-exercise control group or to 1 of 3 weekly physical activity groups. The DREW study is evaluating the dose-response of exercise training in regard to changes in multiple cardiac risk factors. This study will measure diastolic heart function in a subset of the DREW population in order to examine the relationship between dose response, changes in physical activity, and diastolic function. Diastolic heart function will be assessed using both traditional and novel echocardiographic measures.
Read the detailed description
BACKGROUND:
Congestive heart failure (CHF) has become the number one reason for hospitalization in the United States. Diastolic heart dysfunction is becoming increasingly recognized as a significant factor in the etiology of CHF. Of the total affected population, 70% of patients with diastolic heart failure are female, the majority of which are elderly. There is currently no effective pharmacological therapy for the treatment of diastolic heart dysfunction. Existing cross-sectional studies and limited training trials supporting the hypothesis that exercise may improve diastolic function have only studied men. There is a need for more properly controlled and adequately powered studies examining the effect of exercise training on diastolic function, particularly in populations at high risk for CHF, such as sedentary, postmenopausal women with elevated blood pressure.
DESIGN NARRATIVE:
A total of 215 sedentary, postmenopausal women at moderate risk for cardiovascular disease will be randomly assigned to receive either exercise training or no exercise for six months. This study will measure diastolic heart function using novel echocardiographic measurements, such as pulmonary vein flow pattern, tissue Doppler, and color M-mode mitral inflow propagation velocity. The study will also measure the left ventricular mass.
- Conditions
- Heart Failure, Congestive, Cardiovascular Diseases
- Being tested
- Exercise
- Keywords
- Postmenopause
- Medical subject headings
- Heart Failure, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastolic function as assessed by mitral inflow filling pattern (E/A ratio) (measured at Month 6)
Secondary outcomes (4)
Pulmonary vein flow pattern
Tissue Doppler
Color M-mode mitral inflow propagation velocity
Left ventricular mass (measured at Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2005 (estimated)
- Study startJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Steven Blair, Study chair, The Cooper Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125476
- Sponsor's protocol ID
- 235
- Other IDs
- R21HL077165
- Status last verified
- Oct 2006
- First submitted
- 29 Jul 2005
- Last updated
- 11 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training and Diastolic Function in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00125476
- Acronym / sponsor ID
- 235
- Conditions
- Heart Failure, Congestive, Cardiovascular Diseases
- Keywords
- Postmenopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 2004
- First posted
- 1 Aug 2005 (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 a prospective follow-up study to the Dose-Response to Exercise in Women (DREW) study. In DREW, 450 overweight, sedentary postmenopausal women were randomly assigned to either a non-exercise control group or to 1 of 3 weekly physical activity groups. The DREW study is evaluating the dose-response of exercise training in regard to changes in multiple cardiac risk factors. This study will measure diastolic heart function in a subset of the DREW population in order to examine the relationship between dose response, changes in physical activity, and diastolic function. Diastolic heart function will be assessed using both traditional and novel echocardiographic measures.
Detailed description
BACKGROUND:
Congestive heart failure (CHF) has become the number one reason for hospitalization in the United States. Diastolic heart dysfunction is becoming increasingly recognized as a significant factor in the etiology of CHF. Of the total affected population, 70% of patients with diastolic heart failure are female, the majority of which are elderly. There is currently no effective pharmacological therapy for the treatment of diastolic heart dysfunction. Existing cross-sectional studies and limited training trials supporting the hypothesis that exercise may improve diastolic function have only studied men. There is a need for more properly controlled and adequately powered studies examining the effect of exercise training on diastolic function, particularly in populations at high risk for CHF, such as sedentary, postmenopausal women with elevated blood pressure.
DESIGN NARRATIVE:
A total of 215 sedentary, postmenopausal women at moderate risk for cardiovascular disease will be randomly assigned to receive either exercise training or no exercise for six months. This study will measure diastolic heart function using novel echocardiographic measurements, such as pulmonary vein flow pattern, tissue Doppler, and color M-mode mitral inflow propagation velocity. The study will also measure the left ventricular mass.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Physically inactive for 6 months prior to study entry; defined as sedentary and having an energy expenditure of less than 35 kcal(kgˉ¹)(dayˉ¹)
- Postmenopausal and fits one of the following criteria: over 55 years old and no natural menses for at least 5 years; less than 55 years old and no natural menses for at least 2 years and a serum follicle stimulating hormone (FSH) level greater than 40 mIU/ml; hysterectomy with documentation of bilateral oophorectomy; less than 55 years old with a hysterectomy but no documentation of bilateral oophorectomy and with an FSH level greater than 40 mIU/ml and estradiol level less than 25 pg/ml
- If taking hormone replacement therapy, must have been on a stable dose for at least 6 months, and must maintain the same dosage of the same medication throughout the study
- Body mass index between 25 and 40 kg/m²
- Systolic blood pressure between 120 and 159 mm Hg and diastolic blood pressure no greater than 99 mm Hg
Key exclusion criteria (9 listed)
- Currently taking any antihypertensive medications
- Current or history of significant cardiovascular diseases or disorders, including arrythmias; myocarditis; cardiomyopathy; congestive heart failure; stroke or transient ischemic cerebral attacks; peripheral vascular disease with intermittent claudication; acute, chronic, or recurrent thrombophlebitis; and Stage II or III hypertension
- Current or history of total cholesterol level of at least 240 mg/dl with LDL-C level of at least 160 mg/dl or triglyceride levels of at least 300 mg/dl
- Current or history of hematologic disorders, including anemias, bleeding disorders, chronic thrombotic disorders, or hypercoagulable states
- Recent blood donation within the 6 weeks before study entry (participants also will be asked to refrain from blood donation during the study)
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 |
|---|---|---|
| Exercise | Behavioural | – |
Primary outcome
Diastolic function as assessed by mitral inflow filling pattern (E/A ratio) (measured at Month 6)
4 secondary outcomes
Pulmonary vein flow pattern
Tissue Doppler
Color M-mode mitral inflow propagation velocity
Left ventricular mass (measured at Month 6)
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 11 Oct 2006.
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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.
Steven Blair study chair
The Cooper Institute
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 Heart Failure, Congestive and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) 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 7 inclusion and 9 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 11 Oct 2006. 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?
Diastolic function as assessed by mitral inflow filling pattern (E/A ratio) (measured at Month 6). 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 11 Oct 2006.