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Weight Loss in Pre-Hypertensive Patients With Diastolic Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00911209
Recruitment Status : Terminated (Terminated because funding was not found)
First Posted : June 1, 2009
Last Update Posted : October 15, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
The focus of this study is to observe the impact of weight loss in overweight individuals who have pre-hypertension (have a blood pressure reading of 121-139/81-89 mm Hg). The specific focus is to observe the difference in diastolic dysfunction (heart function) in these individuals at the beginning of the study and then again after 24-28 weeks. Diastolic dysfunction in this population indicates an increased risk of heart failure in the future. The aim of this study is to prevent or reduce the risk of heart failure in overweight individuals with pre-hypertension.

Condition or disease Intervention/treatment
Obesity Heart Disease Weight Loss Diastolic Dysfunction Behavioral: Dietitian counselling

Detailed Description:
You will be enrolled in the study for 24-28 weeks and will be randomly assigned to one of two assigned group. One group of subjects (Intervention group) will receive information on Heart healthy diet, lifestyle recommendations and diet and exercise counseling with a dietitian in order to achieve at least 7% weight loss. The other group will receive standard of care i.e., Information on Heart healthy diet at baseline visit (Standard of care group). The following is the time line of activities anticipated by the subject in each group. Both the groups will be screened at 3 different visits within 4 weeks to determine eligibility. If you are eligible they will be randomized to either be in Standard of care group or Intervention group. After randomization, the "Standard of care group" will come for Baseline and Final visit (24th week). The Intervention group will have 14 weekly visits with a nutritionist and 1 monthly visit, about 40-50 minutes each visit (total of 15) in 24- 28 week time frame. The second monthly session will be the final assessment visit. Both the groups will have a Baseline Assessment and a Final Assessment visit which will last about 3 hours.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Weight Loss on Diastolic Dysfunction in Overweight Pre-Hypertensives
Study Start Date : July 2008
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intervention
The Intervention group at each session will receive information on Heart healthy diet, lifestyle recommendations and diet and exercise counseling with a dietitian in order to achieve at least 7% weight loss (for example a person weighing 200 pounds will be encourage to lose at least 14 pounds).
Behavioral: Dietitian counselling
Once a week for 14 weeks then 1 monthly visit. Visits last 40-50 minutes
No Intervention: No Intervention
The standard of care group will receive information on Heart healthy diet at baseline visit and will return to a final visit about 28 weeks later.

Outcome Measures

Primary Outcome Measures :
  1. Determine if weight loss is associated with changes in separate components of cardiac function. [ Time Frame: 32 weeks ]

Secondary Outcome Measures :
  1. Determine whether specific cardiac markers will be altered in patients with diastolic dysfunction treated with low caloric diet and exercise and if these levels will be altered in association with improvement in diastolic function. [ Time Frame: 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults age ≥ 21 years
  • BMI ≥30
  • Individuals with diagnosis pre-hypertension at the time of screening, defined as either a blood pressure measurement of 130-139/85-89 mm Hg
  • Echocardiographic EF >50%
  • Echocardiographic evidence of diastolic dysfunction;

Exclusion Criteria:

  • Patients receiving antihypertensive medications
  • Patients receiving diabetic medication
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911209

United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ragavendra Baliga
Principal Investigator: Ragavendra Baliga, MD, MBA, Ohio State University
More Information

Responsible Party: Ragavendra Baliga, Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00911209     History of Changes
Other Study ID Numbers: 2007H0328
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: October 15, 2012
Last Verified: October 2012

Keywords provided by Ragavendra Baliga, The Ohio State University:
Heart Disease

Additional relevant MeSH terms:
Body Weight
Heart Diseases
Weight Loss
Signs and Symptoms
Cardiovascular Diseases
Body Weight Changes