Myocardial Performance at Rest and During Exercise in Heart Failure With Preserved Ejection Fraction

NCT01747785 | Terminated

• 1 other identifier: 12-005553
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to study how well the heart contracts and relaxes during exercise. In addition to traditional measures of heart function, we will use a new computer program that may improve understanding of why people feel shortness of breath or fatigue.

Conditions

Heart Failure

Keywords

Heart failure; HFpEF; Dyspnea; Fatigue; Shortness of Breath; exercise; strain; myocardial deformation; cardiac rehabilitation; cardiac hemodynamics

Outcome Measures

Primary Outcomes (1)

• Change in mean cardiac reserve as measured by strain rate

  Myocardial deformation imaging (e.g. strain, strain rate, torsion) requires clear 2-dimensional echocardiography images that will be obtain at rest and during mild and moderate intensity exercise. Images will be captured during 6-10 minute bouts of exercise on a tilting exercise table. Comparisons will be made on resting and exercise values between groups. Our hypothesis is that strain rate will not increase in patients at risk of heart failure demonstrating lack of cardiovascular reserve.

  Baseline, 12 weeks

Secondary Outcomes (1)

• Change in mean cardiac stroke volume

  Baseline, 12 weeks

Study Arms (2)

Healthy controls

Individuals without history of cardiovascular disease and at least 18 years of age will take a baseline (at rest) cardiopulmonary exercise test (CPX) and have a cardiac echocardiogram to measure myocardial deformation. CPX and echocardiograms will be repeated during exercise sessions at 3 visits over a 12 week period.

Other: Myocardial deformation imaging; Other: Cardiopulmonary exercise test

Patients at risk of heart failure

Individuals at risk of heart failure and a preserved ejection fraction of at least 50% will take a baseline (at rest) cardiopulmonary exercise test (CPX) and have a baseline cardiac echocardiogram to measure myocardial deformation. CPX and echocardiograms will be repeated during exercise sessions at 6 visits over a 12 week period. A cardiac rehabilitation exercise program will also occur over 12 weeks.

Other: Cardiac rehabilitation; Other: Myocardial deformation imaging; Other: Cardiopulmonary exercise test

Interventions

Cardiac rehabilitation OTHER

Aerobic cardiac exercise training will be provided over the 12 week study duration.

Patients at risk of heart failure

Myocardial deformation imaging OTHER

A 2D Doppler echocardiograph (image) of the heart will be captured during a single heart beat taken at rest and during cardiopulmonary exercise tests to measure left and right ventricular segmental systolic and diastolic strain measurements.

Healthy controls; Patients at risk of heart failure

Cardiopulmonary exercise test OTHER

The cardiopulmonary exercise test consists of cycling exercise of mild and moderate intensity on an upright cycle ergometer on a tilting table (to facilitate imaging) for 6-10 minute periods within a one hour session.

Healthy controls; Patients at risk of heart failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• years of age or older,
• able to exercise on a bicycle

You may not qualify if:

• heart arrhythmias,
• severe chronic obstructive pulmonary disease,
• congenital heart abnormalities,
• infiltrative or hypertrophic cardiomyopathy.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Health System - Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

Location

MeSH Terms

Conditions

Heart Failure; Dyspnea; Fatigue; Motor Activity; Sprains and Strains

Interventions

Cardiac Rehabilitation; Exercise Test

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Hector Villarraga, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 12, 2012
• Study Start: June 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 17, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)