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Early Detection of Diastolic Dysfunction and the Role of Lifestyle Measures in Its Treatment

This study has been completed.
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00998114
First received: October 19, 2009
Last updated: June 15, 2011
Last verified: June 2011
History of Changes
  Purpose

The project aims to investigate the effect of a regular exercise for 6 months on diastolic parameters in patients who present with shortness of breath and who have evidence of early diastolic dysfunction on echocardiography. Patients will be enrolled from the VA General Medicine and Cardiology Clinics, and will be screened for diastolic dysfunction. Once enrolled, they will be on an exercise regimen that involves aerobic exercise for 30-45 minutes five times a week at home. The participants will have an initial supervised exercise session with the VA Cardiac Rehabilitation team, and will have either every other week or monthly supervised sessions at the VA Cardiac Rehabilitation Center to monitor their progress. Clinical, biometric, laboratory and echocardiographic parameters will be obtained before and after the 6 month period.


Condition Intervention
Diastolic Dysfunction
 Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Detection of Diastolic Dysfunction and the Role of Lifestyle Measures in Its Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Exercise echo Doppler will be done at baseline and after completion of 6 months of an exercise program [ Time Frame: Beginning of study participation and after 6 months of study participation ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2008
Study Completion Date: May 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise and diastolic dysfunction Behavioral: Exercise
Aerobic exercise for 30-45 minutes five times a week for six months
Other Name: Diastolic Dysfunction

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with dyspnea/shortness of breath
  • Age 40-65 years of age
  • Sedentary lifestyle (<150 minutes of exercise/week)
  • Echocardiographic evidence of early diastolic dysfunction: mitral E/A <0.9, OR resting E/E' between 8-15 cm/s, OR post-exercise E/E' >13 cm/s.

Exclusion criteria:

  • Age <40 years or >65 years
  • Coronary Artery Disease by angiography or evidence of ischemia on a stress test
  • Systolic Dysfunction (LV Ejection fraction <50%)
  • Congestive Heart Failure Functional Class III or IV
  • Moderate to severe COPD (FEV <80% predicted)
  • Moderate to severe valvular heart disease, except tricuspid regurgitation
  • Inability to get heart rate >/= 85% of maximum predicted heart rate
  • Uncontrolled hypertension (systolic BP>140mmHg, diastolic BP>90mmHg) despite medical therapy
  • On echocardiogram, RV systolic pressure >60mmHg that suggests severe pulmonary hypertension
  • On echocardiogram, left atrial size> 6.5 cm or left atrial volume > 35 ml/BSA
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998114

Locations
United States, Missouri
Harry S Truman Veterans Administration Hospital
Columbia, Missouri, United States, 65201
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Anand Chockalingam, MD University of Missouri/Harry S Truman VA Hospital
  More Information

No publications provided

Responsible Party: Anand Chockalingam, MD, Assistant Clinical Professor of Medicine, University of Missouri
ClinicalTrials.gov Identifier: NCT00998114     History of Changes
Other Study ID Numbers: 1115737
Study First Received: October 19, 2009
Last Updated: June 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Early Cardiac Diastolic Dysfunction
Aerobic Exercise
Weight Reduction

ClinicalTrials.gov processed this record on May 23, 2013