- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00998114
Early Detection of Diastolic Dysfunction and the Role of Lifestyle Measures in Its Treatment
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
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Columbia, Missouri, United States, 65201
- Harry S Truman Veterans Administration Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise and diastolic dysfunction
Aerobic exercise for 30-45 minutes five times a week for six months
|
Aerobic exercise for 30-45 minutes five times a week for six months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Beginning of study participation and after 6 months of study participation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anand Chockalingam, MD, University of Missouri/Harry S Truman VA Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1115737
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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