INcrease Of VAgal TonE in CHF (INOVATE-HF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by BioControl Medical
Sponsor:
Information provided by (Responsible Party):
BioControl Medical
ClinicalTrials.gov Identifier:
NCT01303718
First received: February 18, 2011
Last updated: June 30, 2014
Last verified: February 2014
  Purpose

The purpose of the INOVATE-HF study is to demonstrate the long-term safety and efficacy of vagus nerve stimulation with the CardioFit® system for the treatment of subjects with Heart Failure.


Condition Intervention Phase
Left Ventricular Dysfunction
Heart Failure
Device: CardioFit® System
Other: Standard of Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: INcrease Of VAgal TonE in CHF (INOVATE-HF) - A Randomized Study to Establish the Safety and Efficacy of CardioFit® for the Treatment of Subjects With Heart Failure and Left Ventricular Dysfunction

Resource links provided by NLM:


Further study details as provided by BioControl Medical:

Primary Outcome Measures:
  • Number of participants reaching all-cause mortality or unplanned heart failure hospitalization or equivalent. [ Time Frame: Until the end of the study ] [ Designated as safety issue: No ]
    The primary efficacy end-point of the study is the composite of all-cause mortality or unplanned heart failure hospitalization equivalent using a time to first event analysis, as compared between the two study arms after a pre-specified number of such events have been accumulated.

  • Co-Primary Safety Endpoints: a) Freedom from procedure and system related complication events and b) Number of all-cause death cases or complications resulting in hospitalization [ Time Frame: a) 90 days and b) Until the end of the study ] [ Designated as safety issue: Yes ]

    The co-primary safety endpoints of the study are the following:

    1. Freedom from procedure and system related complication events through 90 days
    2. Demonstrate time to first event equivalence in all-cause mortality and complications resulting in prolonged hospitalization between the Control and CardioFit


Secondary Outcome Measures:
  • The rate of unplanned heart failure hospitalization equivalents [ Time Frame: Until the end of the study ] [ Designated as safety issue: No ]
    The rate of unplanned heart failure hospitalization equivalents

  • Mean improvement in LVESVi from baseline to 12-months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Mean improvement in LVESVi from baseline to 12-months

  • Mean improvement in the summary score of the KCCQ from baseline to 12-months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Mean improvement in the summary score of the KCCQ from baseline to 12-months

  • Mean improvement in 6 minute walk test from baseline to 12-months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Mean improvement in 6 minute walk test from baseline to 12-months

  • All cause mortality and the number of unplanned heart failure hospitalization equivalents [ Time Frame: Until the end of the study ] [ Designated as safety issue: No ]
    All cause mortality and the number of unplanned heart failure hospitalization equivalents

  • Rate of hospitalization-free days [ Time Frame: Until the end of the study ] [ Designated as safety issue: No ]
    Rate of hospitalization-free days

  • Secondary Safety Endpoints: Mortality and Complications [ Time Frame: Until the end of the study ] [ Designated as safety issue: Yes ]

    The following additional (secondary) safety endpoint data will also be evaluated comparatively at 6- and 12-months:

    1. All-cause mortality
    2. Cardiovascular mortality
    3. Serious adverse events
    4. Complications
    5. System- or procedure-related complications


Estimated Enrollment: 650
Study Start Date: February 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CardioFit® System
Vagal nerve stimulation with the CardioFit® system
Device: CardioFit® System
Vagal nerve stimulation with the CardioFit® system
Other Name: CardioFit® System
Active Comparator: Standard of Care
Usual care (no CardioFit System implant)
Other: Standard of Care
Usual care for LV dysfunction and heart failure (no CardioFit System implant)
Other Name: Standard of Care

Detailed Description:

Prospective, Randomized (3:2 active:control), Open Label, Event-driven Interventional Study. All subjects undergo the following: Baseline, Randomization, (Implantation & Optimization for subjects randomized to the active therapy), and Follow-up Period, followed by an Extension period, which lasts until the end of the study. The Clinical Events Committee (CEC) and Data Monitoring and Safety Board (DSMB) will conduct scheduled independent reviews of the data at the following time-points in order to ensure that an ongoing acceptable safety profile is being achieved.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chronic symptomatic heart failure in New York Heart Association functional class III.
  2. Age of at least 18 years.
  3. Subjects should be predominately in sinus rhythm at the time of enrollment.
  4. On stable optimally uptitrated medical therapy recommended according to current guidelines as standard of care for heart failure therapy.
  5. LVEF ≤ 40% per site measurement within three months before enrollment.
  6. The left ventricular end diastolic diameter, per site measurement, should be between 50 and 80 mm.
  7. The subject is a male or postmenopausal female. Females of childbearing age may be included if an acceptable contraception measure is used.
  8. Subject must sign an approved informed consent form. Subject agrees to attend all followup evaluations.
  9. Subjects with CRT devices may be included in the trial provided they have had CRT for at least 12 months.

Exclusion Criteria:

  1. Presence of a life threatening condition or disease other than heart failure, that is likely to lead to death within 6 months.
  2. Acute myocardial infarction (MI), variant angina pectoris, unstable angina or acute coronary syndrome in the previous one month.
  3. History of stroke or TIA within the previous 3 months or significant neurological damage that would impair the ability to respond to or detect improvement with the vagal nerve stimulation.
  4. Coronary Artery Bypass Surgery (CABG), valve replacement or repair, aortic surgery or PCI) in the prior 3 months or planned/anticipated within 6 months.
  5. Heart failure due to acute myocarditis, restrictive cardiomyopathy, constrictive pericarditis or hemodynamically significant aortic valve insufficiency, aortic stenosis, or mitral valve stenosis.
  6. Severe renal failure (creatinine level > 3 mg/dL (265 micromole/liter).
  7. Severe hepatic failure (transaminase level four times ULN, or total bilirubin level > 1.8 mmol/dL).
  8. Uncontrolled Diabetes Mellitus, which in the opinion of the investigator, would compromise the safety of the implant procedure and/or the ability to respond or detect improvement with vagal nerve stimulation.
  9. Previous right neck surgery, including for cerebrovascular disease (CVD), malignancy, and previous irradiation therapy of the neck, which in the opinion of the implanting surgeon, would preclude safe implantation of the vagal nerve cuff. Subjects with more than 70% right carotid artery stenosis assessed on carotid ultrasound are excluded.
  10. Current hypotension (systolic blood pressure below 80 mmHg).
  11. Active peptic ulcer disease or history of upper GI bleeding, or ulcer within 6 months.
  12. History of lung disease such as severe asthma, COPD (e.g., FEV1<1.5 liter) or continuous oxygen dependence.
  13. 2nd or 3rd degree AV block or other pacemaker indication that is not treated with a pacemaker.
  14. Chronic atrial fibrillation or flutter in the previous 3 months, or hospitalization for AF due to clinical manifestations of such in the last 6 months.
  15. Use of unipolar sensing
  16. Congenital or acquired long QT syndrome.
  17. Documented recorded or suspected vaso-vagal syncope or vaso depressor syncope.
  18. Treatment by investigational drug or device within the past 3 months.
  19. The subject must not have received inotropic therapy within 2 months or be considered a possible candidate for inotropic therapy within the next 1 month.
  20. Inability to understand the informed consent and/or prior diagnosis of major affective disorder e.g., major depression or bipolar disorder or schizophrenia that requires ongoing treatment and is not adequately controlled by medication.
  21. Subjects transplanted with heart or other tissues or organs, or on a heart transplant waiting list and anticipated to receive a transplant within 6 months of randomization.
  22. Immunosuppressed subjects; subjects under systemic steroid treatment.
  23. Anemia with Hgb ≤ 9.5 g/L. Treatment with erythropoietin or other similar agents is allowed if used to keep Hgb > 9.5 g/L.
  24. Untreated obstructive sleep apnea ("OSA") with apnea-hypopnea index of 15 or more; or OSA that is treated for less than 3-months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303718

Contacts
Contact: Susan Petersen-Stejskal 612-210-4640 susanps@biocontrol-medical.com
Contact: Nancy Johnson 651-270-8150 njohnson@biocontrol-medical.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: Jose Tallaj, MD         
United States, Alaska
Alaska Heart Institute Recruiting
Anchorage, Alaska, United States, 99508
Principal Investigator: Anki Amos, MD         
United States, Arizona
Banner Research Institute Recruiting
Mesa, Arizona, United States, 85206
Principal Investigator: Alphonse Ambrosia, M.D.         
United States, California
Glendale Memorial Hospital Recruiting
Glendale, California, United States, 91204
Principal Investigator: John McKenzie, MD         
University of Southern California Not yet recruiting
Los Angeles, California, United States, 90033
Principal Investigator: Leslie Saxon, M.D.         
Sutter Memorial Hospital Recruiting
Sacramento, California, United States, 95819
Principal Investigator: John Chin, M.D.         
Chula Vista Heart Clinic Recruiting
San Diego, California, United States, 91910
Principal Investigator: Brett Berman, MD         
United States, Colorado
South Denver Cardiology/Swedish Hospital Recruiting
Denver, Colorado, United States, 80120
Principal Investigator: Ira Dauber, MD         
United States, Florida
Clearwater Cardiovascular Consultants/Morton Plant Recruiting
Clearwater, Florida, United States, 33756
Principal Investigator: Jose Gallastegui, MD         
Principal Investigator: Andrew Hazlitt, MD         
University of Florida Gainesville Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Charles Klodell, MD         
Mayo Clinic Jacksonville Not yet recruiting
Jacksonville, Florida, United States, 32224
Principal Investigator: Mohamad Yamani, MD         
University of Florida Jacksonville/Shands Hospital Not yet recruiting
Jacksonville, Florida, United States, 32209
Principal Investigator: Doug Chapman, MD         
Florida Hospital, CV Research Institute Recruiting
Orlando, Florida, United States, 32803
Principal Investigator: Nandkishore Ranadive, MD         
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Principal Investigator: Viviana Navas, MD         
United States, Georgia
St. Joseph's Hospital Recruiting
Atlanta, Georgia, United States, 30342
Principal Investigator: Donald Jansen, M.D.         
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: David DeLurgio, M.D.         
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
Principal Investigator: Robert Sorrentino, MD         
United States, Illinois
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
Principal Investigator: Geetha Bhat, M.D.         
United States, Indiana
Saint Vincent Medical Group Recruiting
Indianapolis, Indiana, United States, 46260
Principal Investigator: Mary Walsh, M.D.         
Community Heart and Vascular Clinic Recruiting
Indianapolis, Indiana, United States, 46250
Principal Investigator: Krishna Malineni, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Frances Johnson, M.D.         
United States, Louisiana
Oschner Medical Center Not yet recruiting
New Orleans, Louisiana, United States, 70121
Principal Investigator: Hector Ventura, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Kimberly Parks, D.O.         
Beth Israel Deaconess Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Robb Kociol, M.D.         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Keith Aaronson, M.D.         
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: David Lanfear, M.D.         
Detroit Medical Center - Harper Hospital Recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Randy Lieberman, M.D.         
Detroit Clinical Research Center/Botsford Hospital Recruiting
Farmington Hills, Michigan, United States, 48334
Principal Investigator: Salwan Anton, MD         
Michigan Cardiovascular Institute Recruiting
Saginaw, Michigan, United States, 48601
Principal Investigator: Peter Fattal, M.D.         
Munson Medical Center/Traverse Heart and Vascular Recruiting
Traverse, Michigan, United States, 49684
Principal Investigator: Brian Jaffe, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: David Benditt, MD         
United Heart & Vascular Recruiting
Saint Paul, Minnesota, United States, 55102
Principal Investigator: Alan Bank, M.D.         
CentraCare Heart and Vascular Center Recruiting
St. Cloud, Minnesota, United States, 56303
Principal Investigator: Simon Milstein, MD         
Park Nicollet / Methodist Recruiting
St. Louis Park, Minnesota, United States, 55426
Principal Investigator: Jay Simonson, M.D.         
United States, Mississippi
University of Mississippi Not yet recruiting
Jackson, Mississippi, United States, 39216
Principal Investigator: Matthew Quin, MD         
Cardiology Associates of North Mississippi Recruiting
Tupelo, Mississippi, United States, 38801
Principal Investigator: Karl Crossen, M.D.         
United States, Missouri
St. Luke's Mid America Heart Institute Recruiting
Kansas City, Missouri, United States, 64111
Principal Investigator: Bethany Austin, M.D.         
Saint Louis University School of Medicine Not yet recruiting
St Louis, Missouri, United States, 63104
Contact: Paul Hauptman, MD         
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Gregory Ewald, MD         
Sub-Investigator: Doug Mann, MD         
United States, Nebraska
Bryan Heart Institute Recruiting
Lincoln, Nebraska, United States, 68506
Principal Investigator: Steve Krueger, M.D.         
United States, Nevada
Health Care Partners Cardiology/St. Rose Hospital Recruiting
Las Vegas, Nevada, United States, 89169-2579
Principal Investigator: Dhiraj Narula, MD         
United States, New Jersey
Hackensack Medical Center Recruiting
Hackensack, New Jersey, United States, 07601-1901
Principal Investigator: John Zimmerman, MD         
Atlantic Heath System: Gagnon Cardiovascular Institute Recruiting
Morristown, New Jersey, United States, 07962
Principal Investigator: Marc Goldschmidt, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Principal Investigator: Ronald Zolty, M.D.         
Mount Sinai Recruiting
New York, New York, United States, 10029
Principal Investigator: Vivek Reddy, MD         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Principal Investigator: Hal Skopicki, MD         
United States, Ohio
Aultman Hospital Recruiting
Canton, Ohio, United States, 44710
Principal Investigator: Ira Friedlander, M.D.         
University of Cincinnati Not yet recruiting
Cincinnati, Ohio, United States, 45267-0542
Principal Investigator: Mehran Attari, MD         
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Principal Investigator: Mark Dunlap, M.D.         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Eiran Gorodeski, MD         
Sub-Investigator: Randy Starling, MD         
The Ohio State Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Ayesha Hasan, M.D.         
ProMedica Health System Recruiting
Toledo, Ohio, United States, 43606
Principal Investigator: Gopinath Upamaka, MD         
United States, Oklahoma
Oklahoma Cardiovascular Research Group Recruiting
Oklahoma City, Oklahoma, United States, 73120
Principal Investigator: Philip Adamson, M.D.         
United States, Pennsylvania
Hershey Medical Center/Penn State Recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: Barry Clemson, M.D.         
Lancaster Heart and Stroke Foundation Recruiting
Lancaster, Pennsylvania, United States, 17602
Principal Investigator: Roy Small, MD         
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Paul Mather, M.D.         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Principal Investigator: George Sokos, D.O.         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Samir Saba, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: Jennifer Peura, MD         
Sub-Investigator: Michael Gold, MD         
United States, Tennessee
VA Tennessee Valley Healthcare System Recruiting
Nashville, Tennessee, United States, 37212
Principal Investigator: Henry Ooi, M.D.         
United States, Texas
Lone Star Heart Center Recruiting
Amarillo, Texas, United States, 79106
Principal Investigator: Suresh Neelagaru, M.D.         
Texas Cardiac Arrhythmia (TCA) Recruiting
Austin, Texas, United States, 78705
Principal Investigator: Robert Canby         
Dallas Cardiovascular Associates (CRSTI) Recruiting
Dallas, Texas, United States, 75230
Principal Investigator: Eric Eichhorn, M.D.         
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75226
Principal Investigator: Shelley Hall, M.D.         
St Lukes Episcopal Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Reynolds Delgado, M.D.         
Brooke Army Medical Center Not yet recruiting
San Antonio, Texas, United States, 78234
Principal Investigator: James Watts, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Principal Investigator: Edward M Gilbert, MD         
United States, Virginia
Sentara Norfolk Hospital Recruiting
Norfolk, Virginia, United States, 23507
Principal Investigator: John Herre, MD         
United States, Washington
Kootenai Heart Clinic Recruiting
Spokane, Washington, United States, 99204
Principal Investigator: Tim Lessmeier, M.D.         
United States, Wisconsin
Aurora Health Care Recruiting
Lake Geneva, Wisconsin, United States, 53147
Principal Investigator: Imran Niazi, MD         
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Principal Investigator: Peter Smith, M.D.         
Belgium
Onze Lieve Vrouwziekenhuis Recruiting
Aalst, Belgium, 9300
Principal Investigator: Marc Vanderheyden, MD         
Ziekenhuis Oost Limburg Recruiting
Genk, Belgium, 3600
Principal Investigator: Wilfried Mullens, MD         
Universitair Ziekenhuis Campus Gasthuisberg Recruiting
Leuven, Belgium, 03000
Principal Investigator: Johan van Cleemput, MD, PhD         
Germany
Uniklinikum Aachen Recruiting
Aachen, Germany, 52074
Principal Investigator: Matthias Zink, M.D.         
Charite Campus Virchow-Klinikum Medizinische Klinik mit Schwerpunkt Kardiologie Recruiting
Berlin, Germany, 13353
Principal Investigator: Wilhelm Haverkamp, M.D., Ph.D.         
St. Josef Hospital Recruiting
Bochum, Germany, 44791
Principal Investigator: Andreas Mugge, MD, PhD         
Uniklinikum Bonn Recruiting
Bonn, Germany, 53105
Principal Investigator: Joerg Schwab, M.D., Ph.D.         
Asklepios St Georg Hospital Recruiting
Hamburg, Germany, 20099
Principal Investigator: Karl-Heinz Kuck, PhD         
MHH Klinik für Kardiologie und Angiologie Recruiting
Hannover, Germany, 30625
Principal Investigator: Hanno Oswald, M.D.         
University of Medicine Mannheim Recruiting
Mannheim, Germany, 68167
Principal Investigator: Juergen Kuschyk, M.D.         
Sub-Investigator: Martin Borggrefe, MD         
Uniklinikum Muenster Recruiting
Muenster, Germany, 48149
Principal Investigator: Joerg Stypmann, M.D.         
Israel
Barzilai Medical Center Recruiting
Ashkelon, Israel, 78278
Principal Investigator: Amos Katz, MD         
Bnei-Zion Hospital Recruiting
Haifa, Israel, 33394
Principal Investigator: Uri Rosenschein, MD, MBA         
Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Principal Investigator: Sorel Goland, MD         
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands
Principal Investigator: Peter van der Meer, MD         
Sub-Investigator: Dirk J van Veldhuisen, Prof         
Maastricht University Medical Center Recruiting
Maastricht, Netherlands
Principal Investigator: Hans Brunner-La Rocca, MD         
Erasmus University Hospital Recruiting
Rotterdam, Netherlands, 3015 CE
Principal Investigator: Tamas Szili-Török, MD         
Serbia
Clinical Centre of Serbia Recruiting
Belgrade, Serbia, 11000
Principal Investigator: Goran Milasinovic, M.D., Ph.D.         
Clinical Hosptial Centre Bezanijska Kosa Recruiting
Belgrade, Serbia, 11080
Principal Investigator: Slavica Radovanović, M.D.         
United Kingdom
Golden Jubilee National Hospital Recruiting
Clydebank, Scotland, United Kingdom, G81 4DY
Principal Investigator: Roy Gardner, M.D.         
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom, B15 2TH
Principal Investigator: Sern Lim, MD         
St. Peter's Hospital Recruiting
Chertsey, United Kingdom, KT16 0PZ
Principal Investigator: David Fluck, MD         
University Hospital Coventry Recruiting
Coventry, United Kingdom, CV2 2DX
Principal Investigator: Faisel Osman, MD         
Glenfield Hospital Recruiting
Leicester, United Kingdom, LE3 9QP
Principal Investigator: Andre Ng, MD         
Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6NP
Principal Investigator: Martin Cowie, MD         
John Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Principal Investigator: Tim Betts, MD         
Southampton General Hospital Recruiting
Southampton, United Kingdom, SO16 6YD
Principal Investigator: John Morgan, MD         
Sponsors and Collaborators
BioControl Medical
Investigators
Study Chair: Douglas L. Mann, MD Washington University Early Recognition Center
Study Director: Susan Petersen-Stejskal BioControl Medical
  More Information

Additional Information:
No publications provided by BioControl Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: BioControl Medical
ClinicalTrials.gov Identifier: NCT01303718     History of Changes
Other Study ID Numbers: CP-05-026
Study First Received: February 18, 2011
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by BioControl Medical:
LV Dysfunction
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014