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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00998114
First Posted: October 20, 2009
Last Update Posted: October 5, 2016
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.
Information provided by (Responsible Party):
Anand Chockalingam, University of Missouri-Columbia
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Anand Chockalingam, 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 ]

Enrollment: 9
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
Aerobic exercise for 30-45 minutes five times a week for six months
Behavioral: Exercise
Aerobic exercise for 30-45 minutes five times a week for six months
Other Name: Diastolic Dysfunction

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Anand Chockalingam, Prof Assoc, Medicine-Cardiology, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00998114     History of Changes
Other Study ID Numbers: 1115737
First Submitted: October 19, 2009
First Posted: October 20, 2009
Last Update Posted: October 5, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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