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UPBEAT: Exercise to Treat Depression in Individuals With Coronary Heart Disease

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT00302068
Collaborator
Pfizer (Industry)
101
Enrollment
1
Location
3
Arms
65
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Some individuals with coronary heart disease (CHD) suffer from depression and use antidepressant medications to reduce symptoms. However, preliminary research has shown that exercise may be a more effective way to treat depression in these individuals. The purpose of this study is to evaluate the effects of exercise in reducing depression and improving heart function in individuals with CHD.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Coronary heart disease (CHD) is caused by a narrowing of the small blood vessels that supply blood and oxygen to the heart. It is the leading cause of death in the United States. Recent evidence has suggested that depression is a significant risk factor for individuals with CHD and may place additional strain on the heart. Selective serotonin reuptake inhibitors (SSRIs), a type of antidepressant medication, have been shown to be especially effective at reducing depression symptoms, particularly for individuals with CHD. However, many people fail to benefit from medication alone or they experience negative side effects. Therefore, a need exists to identify alternative approaches for treating depression in individuals with CHD. Preliminary research has shown that exercise may be an effective way to improve mood and treat depression. More research, however, is needed to confirm the benefits of exercise in individuals with CHD. The purpose of this study is to compare the effectiveness of a supervised exercise program, antidepressant treatment, and placebo in reducing depression and improving heart function in individuals with CHD.

This 16-week study will enroll adults with a history of CHD and depression. Participants will be randomly assigned to an aerobic exercise program, antidepressant medication, or placebo. At study entry, standardized psychological questionnaires will be completed and depression levels and exercise tolerance will be assessed. Participants' heart function will be evaluated through measures of flow-mediated vasodilatation, inflammation, platelet function, baroreflex, and heart rate variability. Participants assigned to the exercise program will be required to engage in structured aerobic exercise. Participants assigned to antidepressant medication will receive sertraline, an SSRI or placebo. The treating psychiatrist will be blinded to pill condition and will use supportive measures to help manage medication side effects. Outcome assessors will be unaware of patients' treatment assignments, and only the research pharmacist will be aware of which patients are assigned to sertraline or to placebo.

At Week 16, participants will return to the clinic for repeat assessments of baseline measures. A follow-up evaluation will occur six months following the end of treatment, and participants' depression levels and clinical status will be assessed.

Study Design

Study Type:
Interventional
Actual Enrollment :
101 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Understanding the Prognostic Benefits of Exercise and Anti-depressant Therapy (UPBEAT)
Study Start Date :
Jul 1, 2006
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Supervised aerobic exercise, three times per week for 16 weeks.

Behavioral: Supervised Aerobic Exercise
Supervised aerobic exercise, three times per week, for 16 weeks.
Active Comparator: 2

Sertraline (Zoloft), for 16 weeks.

Drug: Sertraline
Sertraline (Zoloft), daily, for 16 weeks.
Placebo Comparator: 3

Placebo control, for 16 weeks.

Drug: Placebo Pill.
Placebo pill, daily, for 16 weeks.

Outcome Measures

Primary Outcome Measures

  1. Hamilton Depression Rating Scale [Measured at 16 weeks]

    The Hamilton Depression Rating Scale ranges from 0 to 52, with lower scores reflecting lower levels of depression and higher scores greater severity of depression.

Secondary Outcome Measures

  1. Heart Rate Variability (HRV) [Baseline, 16 weeks]

    HRV is the variation in the time interval between heart beats. ECG was recorded for 24 hours on a 3-channel digital compact ash Holter recorder. During the recording period, patients engaged in their normal patterns of activity. ECG data were downloaded and edited using the Pathfinder digital ambulatory ECG analyzer (DelMar Reynolds, lrvine, California) and HRV was estimated from the standard deviation of all normal R-R intervals (SDNN)

  2. Percent Change in Flow Mediated Dilation (FMD) [Baseline, 16 weeks]

    Endothelial function assessed by flow mediated dilation (FMD). Brachial artery FMD was assessed following overnight fasting. Longitudinal B-mode ultrasound images of the brachial artery, 4-6 cm proximal to the antecubital crease, were obtained using an Aeuson (Mountain View, California) Aspen ultrasoundplatformwith an 11MHZ linear array transducer. lmages were obtained after 10 min of supine relaxation and during reactive hyperemia, induced following in ation of a forearm pneumatic occlusion cuff to supra-systolic pressure (~200 mmHg) for 5 minutes. FMD was defined as the maximum percent change inarterial diameter relative to restingbaseline from 10-120 sec post-deflation of the occlusion cuff.

  3. C-reactive Protein (CRP) [Baseline, 16 weeks]

  4. Platelet Factor 4 [Baseline, 16 weeks]

  5. Baroreflex Sensitivity (BRS) [Baseline, 16 weeks]

  6. Interleuken 6 (IL-6) [Baseline, 16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Persistent depressive symptoms that may include the following: depressed mood; diminished interest or pleasure in activities; change in appetite; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue or loss of energy; feelings of worthlessness or inappropriate guilt; diminished ability to think or concentrate; or recurrent thoughts of death or suicidal ideations

  • Documented history of coronary heart disease (i.e., a prior heart attack, coronary artery bypass graft, or greater than 75% stenosis in at least one coronary artery)

Exclusion Criteria:

  • Experienced an acute heart attack or any revascularization procedure (i.e., CABG or percutaneous transluminal coronary angioplasty) within 60 days of study entry

  • Left ventricular ejection fraction <30% with labile ECG changes prior to testing

  • Currently using a pacemaker

  • Resting blood pressure greater than 160/100 mmHg

  • Left main disease >50%

  • Failure to meet our criteria for depression or achieve a score of ≥9 on the Beck Depression Inventory-II

  • Any other concurrent psychiatric intervention

  • Primary psychiatric diagnosis other than Major or Minor Depressive Episode

  • Primary diagnosis of the following psychiatric disorders: schizophrenia, bipolar disorder, schizoaffective disorder, other psychotic disorder, dementia, current delirium, current obsessive compulsive disorder

  • Experienced psychotic symptoms during the current depressive episode

  • Current abuse or dependence on alcohol or other drugs

  • Acute suicide risk

  • Patients who, during the course of the study, would likely require treatment with additional psychotherapeutic agents

  • Significant medical conditions that would make exercise or sertraline use medically inadvisable (e.g., unstable angina, heart attack within the 3 months prior to study entry, musculoskeletal problems, or congestive heart failure)

  • Abnormal thyroid-stimulating hormone (TSH) level and glucose level greater than or equal to 126 mg/dL

  • Patients who would not be able to be randomized to either the drug (e.g., adverse cardiac events such as prolonged QT interval, allergic responses) or exercise (e.g., musculoskeletal problems, abnormal cardiac response to exercise, such as exercise-induced VT, abnormal blood pressure response, etc.)

  • Currently using medications that would make exercise or sertraline use medically inadvisable (e.g., clonidine, dicumarol, warfarin, anticonvulsants, or MAO inhibitors)

  • Current uncontrolled medical condition that could be causing the depressive symptoms (e.g., thyroid dysfunction, anemia)

  • Pregnant, planning to get pregnant during the study period, or lactating

  • Herbal supplements with purported mood effects (e.g., St. John's wort, valerian, gingko)

  • Current use of antidepressant medication

  • Currently participating in psychotherapy

  • Currently participating in regular aerobic exercise

  • Documented failure to respond to sertraline therapy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University
  • Pfizer

Investigators

  • Principal Investigator: James A. Blumenthal, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT00302068
Other Study ID Numbers:
  • Pro00011980
  • R01HL080664-01A1
First Posted:
Mar 13, 2006
Last Update Posted:
Jun 29, 2015
Last Verified:
May 1, 2015
Keywords provided by Duke University
Exercise
Additional relevant MeSH terms:
Heart Diseases
Depression
Depressive Disorder
Sertraline

Study Results

Participant Flow

Recruitment Details Enrollment began in June 2006 and ended in September 2010. Participants were recruited from physician referrals, community-based screenings, and mass media advertisements.
Pre-assignment Detail
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Arm/Group Description Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range. Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects. Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
Period Title: Overall Study
STARTED 37 40 24
COMPLETED 36 36 23
NOT COMPLETED 1 4 1

Baseline Characteristics

Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control Total
Arm/Group Description Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range. Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects. Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects. Total of all reporting groups
Overall Participants 37 40 24 101
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
0
0%
Between 18 and 65 years
22
59.5%
24
60%
14
58.3%
60
59.4%
>=65 years
15
40.5%
16
40%
10
41.7%
41
40.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
64.7
(11.0)
63.4
(10.2)
63.5
(11.4)
63.9
(11)
Sex: Female, Male (Count of Participants)
Female
13
35.1%
15
37.5%
4
16.7%
32
31.7%
Male
24
64.9%
25
62.5%
20
83.3%
69
68.3%
Region of Enrollment (participants) [Number]
United States
37
100%
40
100%
24
100%
101
100%

Outcome Measures

1. Primary Outcome
Title Hamilton Depression Rating Scale
Description The Hamilton Depression Rating Scale ranges from 0 to 52, with lower scores reflecting lower levels of depression and higher scores greater severity of depression.
Time Frame Measured at 16 weeks

Outcome Measure Data

Analysis Population Description
All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Arm/Group Description Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range. Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects. Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
Measure Participants 36 37 23
Mean (95% Confidence Interval) [Raw changes in Ham-D scores]
-7.5
-6.1
-4.5
2. Secondary Outcome
Title Heart Rate Variability (HRV)
Description HRV is the variation in the time interval between heart beats. ECG was recorded for 24 hours on a 3-channel digital compact ash Holter recorder. During the recording period, patients engaged in their normal patterns of activity. ECG data were downloaded and edited using the Pathfinder digital ambulatory ECG analyzer (DelMar Reynolds, lrvine, California) and HRV was estimated from the standard deviation of all normal R-R intervals (SDNN)
Time Frame Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description
Analysis based on 93 participants with valid baseline measurements.
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Arm/Group Description Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range. Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects. Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects..
Measure Participants 33 38 22
Baseline
116
(36)
120
(39)
123
(24)
16 Weeks
122
(35)
118
(39)
112
(23)
3. Secondary Outcome
Title Percent Change in Flow Mediated Dilation (FMD)
Description Endothelial function assessed by flow mediated dilation (FMD). Brachial artery FMD was assessed following overnight fasting. Longitudinal B-mode ultrasound images of the brachial artery, 4-6 cm proximal to the antecubital crease, were obtained using an Aeuson (Mountain View, California) Aspen ultrasoundplatformwith an 11MHZ linear array transducer. lmages were obtained after 10 min of supine relaxation and during reactive hyperemia, induced following in ation of a forearm pneumatic occlusion cuff to supra-systolic pressure (~200 mmHg) for 5 minutes. FMD was defined as the maximum percent change inarterial diameter relative to restingbaseline from 10-120 sec post-deflation of the occlusion cuff.
Time Frame Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description
All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Arm/Group Description Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range. Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects. Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
Measure Participants 36 37 23
Number [percentage change]
0.2
0.9
0
4. Secondary Outcome
Title C-reactive Protein (CRP)
Description
Time Frame Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description
All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Arm/Group Description Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range. Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects. Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
Measure Participants 36 37 23
Baseline
2.5
(34)
2.5
(38)
2.4
(23)
16 Week
2.1
(34)
2.5
(38)
2.5
(23)
5. Secondary Outcome
Title Platelet Factor 4
Description
Time Frame Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description
All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Arm/Group Description Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range. Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects. Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
Measure Participants 36 37 23
Baseline
44.1
(36)
34.1
(38)
32.0
(23)
16 Week
35.5
(36)
34.0
(38)
34.4
(23)
6. Secondary Outcome
Title Baroreflex Sensitivity (BRS)
Description
Time Frame Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description
Analysis based on 92 participants with valid baseline measurement.
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Arm/Group Description Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range. Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects. Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
Measure Participants 32 38 22
Baseline
4.8
(32)
4.7
(35)
4.9
(23)
Week 16
4.0
(30)
5.1
(33)
4.1
(21)
7. Secondary Outcome
Title Interleuken 6 (IL-6)
Description
Time Frame Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description
All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Arm/Group Description Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range. Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects. Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
Measure Participants 36 37 23
Baseline
1.98
(34)
1.7
(38)
1.95
(23)
16 Week
1.80
(34)
2.1
(38)
1.85
(23)

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Arm/Group Description Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range. Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects. Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
All Cause Mortality
Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/37 (0%) 0/40 (0%) 0/24 (0%)
Other (Not Including Serious) Adverse Events
Supervised Aerobic Exercise Sertraline (Zoloft) Placebo Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/37 (0%) 0/40 (0%) 0/24 (0%)

Limitations/Caveats

Relatively small sample size. Participants had to be willing to accept the condition to which they were randomly assigned, and patients who were not interested in exercise or taking an antidepressant were unlikely to have volunteered.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. James Blumenthal
Organization DukeUMC
Phone 919-684-3969
Email blume003@mc.duke.edu
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT00302068
Other Study ID Numbers:
  • Pro00011980
  • R01HL080664-01A1
First Posted:
Mar 13, 2006
Last Update Posted:
Jun 29, 2015
Last Verified:
May 1, 2015