N/A
N=40
Chronotropic Incompetence in Patients With HFpEF
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02524145 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Cardiac Beta-receptor Sensitivity — 0.254; 0.156; 0.365 beats per ng/kg/min ISO
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Static Handgrip (Other); Dexmedetomidine (Drug); Glycopyrrolate (Drug); Isoproterenol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Beta-receptor Sensitivity |
0.254; 0.156; 0.365 | — |
| PRIMARY Central Command Regulation of Heart Rate |
93; 89 | — |
Summary
The purpose of this study is to determine the mechanisms of chronotropic incompetence (inability to increase heart rate with exercise) in patients with heart failure and preserved ejection fraction (HFpEF). The investigators will test both central command regulation and cardiac beta-receptor sensitivity over control of heart rate.
Eligibility Criteria
Healthy Controls
Inclusion Criteria
- ages > 60 years
- body mass index 30
- presence of co-morbid conditions including hypertension, diabetes, heart failure, asthma, chronic obstructive pulmonary disease, coronary artery disease as evidenced by angina or prior myocardial infarction or cerebrovascular disease as evidenced by prior transient ischemic attack or stroke
- Patients with chronic orthopedic injury that might make them unable to participate in an exercise testing will also be excluded
- Subjects unable to speak English will not be recruited because of the complex experimental studies and the need for precise communication between the volunteers and the research staff to ensure safety.
HFpEF Subjects
Inclusion Criteria
- Patients will be > 60 years old, male or female, all races.
- signs and symptoms of heart failure
- ejection fraction > 0.50
- objective evidence of diastolic dysfunction.
- All patients must be in sinus rhythm without a left bundle branch block at the time of study
Exclusion Criteria
- underlying valvular or congenital heart disease
- restrictive or infiltrative cardiomyopathy
- acute myocarditis
- New York Heart Association (NYHA) Class IV congestive heart failure, or heart failure that cannot be stabilized on medical therapy
- other condition that would limit the patient's ability to complete the protocol
- manifest ischemic heart disease
- Coumadin/warfarin therapy
- Patients with chronic orthopedic injury that might make them unable to participate in an exercise testing will also be excluded
- Subjects unable to speak English will not be recruited because of the complex experimental studies and the need for precise communication between the volunteers and the research staff to ensure safety.
Data sourced from ClinicalTrials.gov (NCT02524145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.