Weight Loss in Pre-Hypertensive Patients With Diastolic Dysfunction

Ragavendra Baliga

Status: Terminated

Conditions: Weight Loss; Diastolic Dysfunction; Obesity; Heart Disease

Treatments: Behavioral: Dietitian counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT00911209

2007H0328

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Intervention

Experimental group

Description:

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).

Treatment:

Behavioral: Dietitian counselling

No Intervention

No Intervention group

Description:

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.