Complications in Hypertension and Obesity

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Almazov Federal Center of Heart, Blood and Endocrinology
Sponsor:
Information provided by (Responsible Party):
Conrady Alexandra, Almazov Federal Center of Heart, Blood and Endocrinology
ClinicalTrials.gov Identifier:
NCT00552292
First received: October 31, 2007
Last updated: January 11, 2012
Last verified: January 2012
  Purpose

The study in aimed to investigate epidemiology of risk factors in Russian Federation its prognostic value aimed on acceptance of national specific definition of metabolic syndrome and guidelines for its management.


Condition
Metabolic Syndrome
Hypertension
Obesity
Dyslipidemia
Hyperglycemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Investigation of Cardiovascular Complications in Arterial Hypertension and Obesity

Resource links provided by NLM:


Further study details as provided by Almazov Federal Center of Heart, Blood and Endocrinology:

Primary Outcome Measures:
  • cardiovascular complications [ Time Frame: 2007-2017 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • diabetes mellitus [ Time Frame: 2007-2017 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood, urine, serum


Estimated Enrollment: 30000
Study Start Date: December 2007
Estimated Study Completion Date: January 2017
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Age and sex-matched sample of subjects older 18 age

Criteria

Inclusion Criteria:

  • Age older 18 years
  • Signed informed consent
  • Blood pressure more than 130 and/or 85 mm Hg
  • Waist circumference more than 80 sm in females and 94 in males and/or BMI more than 25 kg/m2
  • Dyslipidemia (elevated TG and/or decreased level of HDLP or therapy for high triglyceride level)
  • Fasting glucose more than 5,6 mmol/l

Exclusion Criteria:

  • Associated clinical conditions (stroke, TIA, MI, heart failure, renal disease, diabetes mellitus)
  • Severe concomitant diseases affecting outcome
  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: NCT00552292

Contacts
Contact: Alexandra O Conrady, MD, PhD +7812-70255-71 ahleague@mail.ru
Contact: Elena I Baranova, professor 346-9082 ext +7812 eibaranova@yahoo.com

Locations
Russian Federation
Almazov Federal Center of Heart, Blood and Endocrinology Recruiting
St.Petersburg, Russian Federation, 194156
Contact: Oxana P Rotari, MD    7-812-7025556    rotariox@mail.ru   
Principal Investigator: Oxana Rotari, MD         
Sponsors and Collaborators
Almazov Federal Center of Heart, Blood and Endocrinology
Investigators
Study Director: Eugene V Shlyakhto Almazov Federal Center of Heart, Blood and Endocrinology
  More Information

No publications provided

Responsible Party: Conrady Alexandra, professor, Almazov Federal Center of Heart, Blood and Endocrinology
ClinicalTrials.gov Identifier: NCT00552292     History of Changes
Other Study ID Numbers: 25/1
Study First Received: October 31, 2007
Last Updated: January 11, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Almazov Federal Center of Heart, Blood and Endocrinology:
metabolic syndrome
hypertension
obesity
dyslipidemia
hyperglycemia
cardiovascular complications

Additional relevant MeSH terms:
Hyperglycemia
Hypertension
Obesity
Dyslipidemias
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on September 14, 2014