Status:
SUSPENDED
Abnormal Vascular, Metabolic, and Neural Function During Exercise in Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Heart Failure With Normal Ejection Fraction
Eligibility:
All Genders
65-85 years
Phase:
NA
Brief Summary
Heart failure with preserved ejection fraction (HFpEF) accounts for approximately half of the heart failure population in the United States. The primary chronic symptom in patients with HFpEF is sever...
Detailed Description
Protocol 1.1: To test hypothesis 1.1 the investigators will measure rapid onset vasodilation in response to a single KE contraction as a marker of vascular responsiveness to muscle contraction, as wel...
Eligibility Criteria
Inclusion
- All subjects will be \>65 years of age. The controls will be screened carefully for hypertension and cardiac disease, including structural heart and hemodynamically significant obstructive coronary disease, using a history, physical examination, and resting and post-exercise transthoracic echocardiograms. Additional exclusion criteria for this group will include valvular heart disease, atrial flutter/ fibrillation, renal insufficiency, chronic lung disease, regular cigarette smoking within the past 10 years, and cardiovascular medication. Subjects demonstrating greater than moderate levels of activity \> 2 days per week will not be allowed to participate, as chronic high levels of physical activity could potentially impact the primary outcome variables.
- HFpEF
- Patients will be \> 65 years old
- We will use a modification of the European Guidelines for the diagnosis of HFpEF to select the patient population.
- The key components of these guidelines include:
- signs and symptoms of heart failure;
- b) an ejection fraction \> 0.50; and
- c) objective evidence of diastolic dysfunction. To satisfy the first criteria, we will use the Framingham criteria (dyspnea, orthopnea, PND, edema); however we will require objective evidence of congestion including
- chest X-ray,
- elevated BNP,
- or elevated PCWP (pulmonary capillary wedge pressure) or
- LVEDP (left ventricular end-diastolic pressure) \> 16 mmHg; for the second, we will accept echo, nuclear or catheter documentation; and for
- we will require a depressed tissue Doppler mitral annular velocity \< 7.5 cm/s along with PCWP \> 16 mmHg if available.
- HFpEF
Exclusion
- underlying valvular or congenital heart disease;
- restrictive or infiltrative cardiomyopathy;
- acute myocarditis;
- NYHA Class IV CHF, or CHF that cannot be stabilized on medical therapy;
- other condition that would limit the patient's ability to complete the protocol;
- manifest ischemic heart disease.
- Patients with CABG or previous history of atrial fibrillation will be allowed to participate, though for safety reasons, patients on Coumadin will be excluded.
- All patients must be in sinus rhythm without a left bundle branch block at the time of study, and be off beta blockers or non-dihydropyridine Ca++ blockers for at least 5 half-lives. β blockers will be weaned over 3-5 days and additional doses of vasodilators added to control blood pressure if necessary. Drugs that affect the renin-angiotensin-aldosterone system and diuretics will be maintained.
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03465072
Start Date
February 1 2018
End Date
March 1 2026
Last Update
April 1 2025
Active Locations (1)
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1
The Institute for Exercise and Environmental Medicine
Dallas, Texas, United States, 75231