Chloroquine to Treat People With Metabolic Syndrome Aim2 (ARCH-MS)

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00455325
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 35
• Location: 1
• Arms: 4
• Actual Duration (Months): 90
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Metabolic syndrome consists of a group of co-occuring conditions that increase an individual's risk of developing heart disease, stroke, and diabetes. The purpose of this study is to evaluate the short-term effectiveness of chloroquine, a protein-activation medication, at improving metabolic syndrome.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome X; Overweight; Hypertension; Dyslipidemias; Prediabetic State	Drug: Placebo Comparator: First Intervention (3 weeks); Drug: Active Comparator: Second Intervention (3 weeks); Drug: Active Comparator: Third Intervention (3 weeks); Drug: Active Comparator: Fourth Intervention (3 weeks)	Phase 2

Detailed Description

Metabolic syndrome is one of the most common disorders in industrialized countries. It consists of abnormal serum lipids, glucose intolerance, elevated blood pressure, and central obesity in the setting of insulin resistance. The syndrome substantially increases the risk of developing diabetes and vascular disease, but there is no clear unifying approach to treat this disorder. In animals, activation of the protein ataxia telangiectasia mutated (ATM) using the antimalarial drug chloroquine improves features of metabolic syndrome and decreases atherosclerosis, a build-up of fatty plaque within arteries. The purpose of this study is to evaluate the effectiveness of short-term treatment with low doses of chloroquine as a way of managing metabolic syndrome.

Participants in this study will initially receive placebo for 3 weeks, followed by increasing doses of chloroquine in three, 3-week intervals. Following each 3-week treatment, participants will be admitted to the research center for one day. There will be a period of no active treatment for 5 to 7 weeks following each admission to the research center to allow recovery from the blood drawing of the clamp procedure before the start of the next treatment interval.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Genotoxic Stress, Atherosclerosis, and Metabolic Syndrome-AIM 2
• Actual Study Start Date: Sep 1, 2004
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: First Intervention (3 weeks) Cohort 1: Chloroquine placebo one tablet daily for 3 weeks, followed by 5-7 week rest period.	Drug: Placebo Comparator: First Intervention (3 weeks); once daily placebo tablet for 3 weeks followed by: euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells; Other Names: Placebo once daily
Active Comparator: Second Intervention (3 weeks) Cohort 2: 80mg chloroquine or placebo tablet once daily for Weeks 3, followed by 5-7 week rest period.	Drug: Active Comparator: Second Intervention (3 weeks); Once daily 80mg chloroquine or placebo tablet 3 Weeks followed by euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells; Other Names: 80 mg chloroquine or placebo tablet once daily
Active Comparator: Third Intervention (3 weeks) Cohort 3: 80mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.	Drug: Active Comparator: Third Intervention (3 weeks); Once daily 80mg tablet for 3 weeks followed by: euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells; Other Names: 80 mg chloroquine tablet once daily
Active Comparator: Fourth Intervention (3 weeks) Cohort 4: 250mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.	Drug: Active Comparator: Fourth Intervention (3 weeks); Once daily 250mg tablet for 3 weeks followed by: euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells; Other Names: 250 mg chloroquine tablet once daily

Outcome Measures

Primary Outcome Measures

1. Insulin Sensitivity [assessed every 8 - 10 weeks at the end of each treatment period]

   Hepatic insulin sensitivity was measured by comparing glucose production at baseline of zero insulin infusion rate with glucose production at 56 pmol/m2/min. Hepatic insulin sensitivity was expressed as the percent suppression, such that greater percent suppression indicated greater hepatic insulin sensitivity. There are no reference values, since the patients served as their own controls.

Secondary Outcome Measures

1. Systolic Blood Pressure [Assessed every 8-10 weeks at the end of each treatment period]

   Two techniques were employed: auscultation of seated subjects at rest was performed by a trained observer who recorded the first and fifth phases of the Korotkoff sounds; and, a portable oscillometric device (SpaceLabs Medical) recorded results every 20 min during the day and every hour during the night. Data were analyzed as mean values over 24 hours.

2. Diastolic Blood Pressure [Assessed every 8-10 weeks at the end of each treatment period.]

   Two techniques were employed: auscultation of seated subjects at rest was performed by a trained observer who recorded the first and fifth phases of the Korotkoff sounds; and, a portable oscillometric device (SpaceLabs Medical) recorded results every 20 min during the day and every hour during the night. Data were analyzed as mean values over 24 hours.

3. Total Cholesterol [Assessed every 8-10 weeks at the end of each treatment period.]

   Fasting Serum Blood Sample

4. Non-HDL Cholesterol [Assessed every 8-10 weeks at the end of each treatment period.]

   Fasting Serum Blood Sample

5. Low-density Lipoprotein [Assessed every 8-10 weeks at the end of each treatment period.]

   Fasting Serum Blood Sample

6. Triglycerides [Assessed every 8-10 weeks at the end of each treatment period.]

   Fasting Serum Blood Sample

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of metabolic syndrome, as determined by at least three of the following five criteria:

1. Elevated fasting triglyceride levels greater than or equal to 150 mg/dL

2. Low HDL cholesterol levels: less than 50 mg/dL for women and less than 40 mg/dL for men

3. Hypertension (=>130/85 mm Hg =<160/100 mm Hg) untreated; or hypertension controlled (=<150/90 mm Hg) on a stable medication regimen for 4 weeks prior to baseline visit.

4. Increased waist circumference: greater than 35 inches in women and greater than 40 inches in men

5. Elevated fasting glucose levels =<100 mg/dL but =>126 mg/dL

• Subjects may be on a stable doses of a statin drug for at least 3 months

• Subjects may be on a stable doses of L-thyroxine for at least 3 months

• Willing to use acceptable form of birth control (e.g., hormonal birth control, double barrier methods)

Exclusion Criteria:

• Prior travel treatment with chloroquine or hydroxychloroquine as follows:

1. any exposure in the past 2 years,

2. 30 days of therapy if exposure was between 2 and 5 years ago,

3. 90 days of therapy if exposure was between 5 and 10 years ago,

4. 6 months of therapy if exposure was 10 to 20 years ago,

5. 1 year of therapy if exposure was 20 to 30 years ago,

6. No limit if last exposure was >30 years ago, ex. during the Vietnam conflict.

• Morbid obesity (body mass index [BMI] greater than 45)

• Coronary artery disease or other vascular disease

• History of stroke

• Chronic kidney insufficiency (i.e.,estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2)

• Diabetes

• Seizure disorder

• History of psoriasis

• Blood disorders, including anemia (i.e., hemoglobin levels less than 13 g/dL in men and less than 12 g/dL in women)

• Current malignancy or active treatment for recurrence prevention, example tamoxifen. Cancer considered to be cured, either as a result of surgery or other treatment is not exclusionary.

• Asthma requiring daily beta agonist therapy or intermittent oral steroids is exclusionary. Inhaled steroids are acceptable. Obstructive sleep apnea will be allowed if Continuous Positive Airway Pressure (CPAP) or other therapy has been stable for 6 months. Other active respiratory diseases are excluded.

• Liver disease, or liver function test results greater than twice the normal value

• Active infection, including HIV

• Serious illness requiring ongoing medical care or medication

• Treatment with atypical anti-psychotic medication. Treatment with any other medication for psychiatric illness, unless on a stable dose for 6 weeks prior to enrollment. Patients with unstable psychiatric disorders are excluded per the decision of the study MD regardless of medication history.

• Taking any of the following lipid lowering medications: niacin, fibrates, and greater than 1 gm fish oils

• Uncontrolled hypertension (BP >150/90) at enrollment.

• Need for daily over the counter medications, or currently taking cimetidine or >1000 IU vitamin E daily and unwilling to reduce or discontinue the use of vitamin E or discontinue cimetidine for the duration of the study. Persons taking >1000 IU of vitamin E should reduce the dose 30 days prior to randomization.

• Pregnant, breastfeeding, or intending to become pregnant

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency

• Retinal disease (in particular, drusen or pigmentary changes at the macula); any ocular disease that interferes with the eye examination (e.g., cataracts)

• Auditory disease or hearing loss; persons with total, irreversible hearing loss can be enrolled.

• Participation in another clinical trial within past 30 days prior to screening and 60 days prior to randomization. Questionnaire or observational studies are not exclusionary.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University in St. Louis	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Clay F. Semenkovich, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• click here for Washington University Research Participant Registry

Publications

• Schneider JG, Finck BN, Ren J, Standley KN, Takagi M, Maclean KH, Bernal-Mizrachi C, Muslin AJ, Kastan MB, Semenkovich CF. ATM-dependent suppression of stress signaling reduces vascular disease in metabolic syndrome. Cell Metab. 2006 Nov;4(5):377-89.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT00455325
• Other Study ID Numbers: 395; P50HL083762
• First Posted: Apr 3, 2007
• Last Update Posted: May 10, 2022
• Last Verified: Apr 1, 2022

• Keywords provided by Washington University School of Medicine: Insulin Resistance; Atherosclerosis; Metabolic Syndrome
• Additional relevant MeSH terms: Metabolic Syndrome; Dyslipidemias; Prediabetic State; Syndrome; Overweight; Chloroquine; Chloroquine diphosphate

Study Results

Participant Flow

Recruitment Details	Eligibility included adults with at least 3 criteria of metabolic syndrome but who did not have diabetes. Subjects were studied in the setting of a single academic health center. First participant was screened on 08 September 2004. The last study visit occurred on 08 June 2010.
Pre-assignment Detail	144 participants were screened

Arm/Group Title	Placebo Comparator: First Intervention (3 Weeks)	Second Intervention (3 Weeks)	Third Intervention (3 Weeks)	Fourth Intervention (3 Weeks)
Arm/Group Description	Chloroquine placebo one tablet daily for 3 weeks Placebo Comparator Limb 1: 1 chloroquine placebo tablet for 3 weeks followed by 5-7 week rest period	80mg Chloroquine weekly for 3 weeks followed by 5-7 week rest period	80mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.	250mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.
Period Title: Cohort 1: Placebo
STARTED	35	0	0	0
COMPLETED	27	0	0	0
NOT COMPLETED	8	0	0	0
Period Title: Cohort 1: Placebo
STARTED	0	27	0	0
COMPLETED	0	26	0	0
NOT COMPLETED	0	1	0	0
Period Title: Cohort 1: Placebo
STARTED	0	0	26	0
COMPLETED	0	0	25	0
NOT COMPLETED	0	0	1	0
Period Title: Cohort 1: Placebo
STARTED	0	0	0	25
COMPLETED	0	0	0	25
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	All Randomized Subject
Arm/Group Description	All Randomized Subjects
Overall Participants	35
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47 (8.5)
Sex: Female, Male (Count of Participants)
Female	26 74.3%
Male	9 25.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 8.6%
Not Hispanic or Latino	32 91.4%
Unknown or Not Reported	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	32 91.4%
Black or African American	3 8.6%
Unknown or not reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Insulin Sensitivity
Description	Hepatic insulin sensitivity was measured by comparing glucose production at baseline of zero insulin infusion rate with glucose production at 56 pmol/m2/min. Hepatic insulin sensitivity was expressed as the percent suppression, such that greater percent suppression indicated greater hepatic insulin sensitivity. There are no reference values, since the patients served as their own controls.
Time Frame	assessed every 8 - 10 weeks at the end of each treatment period

Outcome Measure Data

Analysis Population Description

Full Analysis Set included all randomized participants who completed all procedures in the study arm

Arm/Group Title	Placebo Comparator: First Intervention (3 Weeks)	Second Intervention (3 Weeks)	Third Intervention (3 Weeks)	Fourth Intervention (3 Weeks)
Arm/Group Description	Chloroquine placebo one tablet daily for 3 weeks Placebo Comparator Limb 1: 1 chloroquine placebo tablet for 3 weeks followed by 5-7 week rest period	80mg Chloroquine weekly for 3 weeks followed by 5-7 week rest period	80mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.	250mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.
Measure Participants	27	26	25	25
Mean (Standard Deviation) [% suppression inf rate 56 pmol/m2/min]	.56 (0.04)	0.55 (0.05)	0.66 (0.06)	0.70 (0.04)

2. Secondary Outcome

Title	Systolic Blood Pressure
Description	Two techniques were employed: auscultation of seated subjects at rest was performed by a trained observer who recorded the first and fifth phases of the Korotkoff sounds; and, a portable oscillometric device (SpaceLabs Medical) recorded results every 20 min during the day and every hour during the night. Data were analyzed as mean values over 24 hours.
Time Frame	Assessed every 8-10 weeks at the end of each treatment period

Outcome Measure Data

Analysis Population Description

Full Analysis Set included all randomized participants who completed all procedures in the study arm

Arm/Group Title	Placebo Comparator: First Intervention (3 Weeks)	Second Intervention (3 Weeks)	Third Intervention (3 Weeks)	Fourth Intervention (3 Weeks)
Arm/Group Description	Chloroquine placebo one tablet daily for 3 weeks Placebo Comparator Limb 1: 1 chloroquine placebo tablet for 3 weeks followed by 5-7 week rest period	80mg Chloroquine weekly for 3 weeks followed by 5-7 week rest period	80mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.	Cohort 4: 250mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.
Measure Participants	27	26	25	25
Mean (Standard Deviation) [mmHg]	121 (12)	121 (10)	123 (12)	123 (12)

3. Secondary Outcome

Title	Diastolic Blood Pressure
Description	Two techniques were employed: auscultation of seated subjects at rest was performed by a trained observer who recorded the first and fifth phases of the Korotkoff sounds; and, a portable oscillometric device (SpaceLabs Medical) recorded results every 20 min during the day and every hour during the night. Data were analyzed as mean values over 24 hours.
Time Frame	Assessed every 8-10 weeks at the end of each treatment period.

Outcome Measure Data

Analysis Population Description

Full Analysis Set included all randomized participants who completed procedure.

Arm/Group Title	Placebo Comparator: First Intervention (3 Weeks)	Second Intervention (3 Weeks)	Third Intervention (3 Weeks)	Fourth Intervention (3 Weeks)
Arm/Group Description	Chloroquine placebo one tablet daily for 3 weeks Placebo Comparator Limb 1: 1 chloroquine placebo tablet for 3 weeks followed by 5-7 week rest period	80mg Chloroquine weekly for 3 weeks followed by 5-7 week rest period	80mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.	Cohort 4: 250mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.
Measure Participants	27	26	25	25
Mean (Standard Deviation) [mmHg]	70 (7)	71 (7)	73 (8)	73 (9)

4. Secondary Outcome

Title	Total Cholesterol
Description	Fasting Serum Blood Sample
Time Frame	Assessed every 8-10 weeks at the end of each treatment period.

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who completed study procedure.

Arm/Group Title	Placebo Comparator: First Intervention (3 Weeks)	Second Intervention (3 Weeks)	Third Intervention (3 Weeks)	Fourth Intervention (3 Weeks)
Arm/Group Description	Chloroquine placebo one tablet daily for 3 weeks Placebo Comparator Limb 1: 1 chloroquine placebo tablet for 3 weeks followed by 5-7 week rest period	80mg Chloroquine weekly for 3 weeks followed by 5-7 week rest period	80mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.	250mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.
Measure Participants	27	26	25	25
Mean (Standard Deviation) [mg/dL]	187 (6)	181 (7)	182 (5)	173 (6)

5. Secondary Outcome

Title	Non-HDL Cholesterol
Description	Fasting Serum Blood Sample
Time Frame	Assessed every 8-10 weeks at the end of each treatment period.

Outcome Measure Data

Analysis Population Description

Full Analysis Set included all randomized participants who completed procedure.

Arm/Group Title	Placebo Comparator: First Intervention (3 Weeks)	Second Intervention (3 Weeks)	Third Intervention (3 Weeks)	Fourth Intervention (3 Weeks)
Arm/Group Description	Chloroquine placebo one tablet daily for 3 weeks Placebo Comparator Limb 1: 1 chloroquine placebo tablet for 3 weeks followed by 5-7 week rest period	80mg Chloroquine weekly for 3 weeks followed by 5-7 week rest period	80mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.	250mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.
Measure Participants	27	26	25	25
Mean (Standard Deviation) [mg/dL]	144 (6)	139 (7)	139 (5)	131 (6)

6. Secondary Outcome

Title	Low-density Lipoprotein
Description	Fasting Serum Blood Sample
Time Frame	Assessed every 8-10 weeks at the end of each treatment period.

Outcome Measure Data

Analysis Population Description

Full Analysis Set included all randomized participants who completed procedure.

Arm/Group Title	Placebo Comparator: First Intervention (3 Weeks)	Second Intervention (3 Weeks)	Third Intervention (3 Weeks)	Fourth Intervention (3 Weeks)
Arm/Group Description	Chloroquine placebo one tablet daily for 3 weeks Placebo Comparator Limb 1: 1 chloroquine placebo tablet for 3 weeks followed by 5-7 week rest period	80mg Chloroquine weekly for 3 weeks followed by 5-7 week rest period	80mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.	250mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.
Measure Participants	27	26	25	25
Mean (Standard Deviation) [mg/dl]	115 (5)	109 (6)	109 (5)	103 (6)

7. Secondary Outcome

Title	Triglycerides
Description	Fasting Serum Blood Sample
Time Frame	Assessed every 8-10 weeks at the end of each treatment period.

Outcome Measure Data

Analysis Population Description

Full Analysis Set included all randomized participants who completed procedure.

Arm/Group Title	Placebo Comparator: First Intervention (3 Weeks)	Second Intervention (3 Weeks)	Third Intervention (3 Weeks)	Fourth Intervention (3 Weeks)
Arm/Group Description	Chloroquine placebo one tablet daily for 3 weeks Placebo Comparator Limb 1: 1 chloroquine placebo tablet for 3 weeks followed by 5-7 week rest period	80mg Chloroquine weekly for 3 weeks followed by 5-7 week rest period	80mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.	250mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.
Measure Participants	27	26	25	25
Mean (Standard Deviation) [mg/dL]	143 (14)	153 (16)	151 (18)	140 (16)

Adverse Events

Time Frame	From consent date to final visit an average of 4 to 6 months
Adverse Event Reporting Description	Safety Analysis Set included all randomized participants
Arm/Group Title	First Intervention		Second Intervention		Third Intervention		Fourth Intervention
Arm/Group Description	Placebo Comparator (3 weeks) followed by 5-7 week rest period		80mg Chloroquine weekly (3 weeks) followed by 5-7 week rest period		80mg chloroquine daily (3 weeks)followed by 5-7 week rest period		250mg chloroquine tablet daily(3 weeks) followed by 5-7 week rest period
All Cause Mortality
	First Intervention		Second Intervention		Third Intervention		Fourth Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/27 (0%)		0/25 (0%)		0/25 (0%)
Serious Adverse Events
	First Intervention		Second Intervention		Third Intervention		Fourth Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/27 (0%)		0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	First Intervention		Second Intervention		Third Intervention		Fourth Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/35 (17.1%)		1/27 (3.7%)		1/25 (4%)		1/25 (4%)
Blood and lymphatic system disorders
Phlebitis	1/35 (2.9%)	1	0/27 (0%)	0	0/25 (0%)	0	0/25 (0%)	0
Anemia	1/35 (2.9%)	1	1/27 (3.7%)	1	1/25 (4%)	1	1/25 (4%)	1
Gastrointestinal disorders
Nausea	1/35 (2.9%)	1	1/27 (3.7%)	1	1/25 (4%)	1	0/25 (0%)	0
Injury, poisoning and procedural complications
IV placement difficulties	1/35 (2.9%)	1	0/27 (0%)	0	0/25 (0%)	0	0/25 (0%)	0
IV infiltration	1/35 (2.9%)	1	0/27 (0%)	0	0/25 (0%)	0	0/25 (0%)	0
erythema	1/35 (2.9%)	1	0/27 (0%)	0	0/25 (0%)	0	0/25 (0%)	0
Skin and subcutaneous tissue disorders
Skin reaction to tape	1/35 (2.9%)	1	0/27 (0%)	0	0/25 (0%)	0	0/25 (0%)	0
Surgical and medical procedures
Medication Error	0/35 (0%)	0	1/27 (3.7%)	1	0/25 (0%)	0	0/25 (0%)	0
Vascular disorders
Vasovagal Syncope	1/35 (2.9%)	1	0/27 (0%)	0	0/25 (0%)	0	0/25 (0%)	0

Limitations/Caveats

[Not Specified]

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.