Heart Failure Clinical Trial

Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a

Summary

Heart failure with preserved ejection fraction or HFpEF, represents nearly 50% of all heart failure cases and is particularly common in the elderly. The disease has no current treatment options. Symptoms typically occur during exertion or exercise and is likely the result of increased cardiac and pulmonary congestion as a result of impaired diastolic function. Istaroxime is a novel activator of SERCA2a, an important regulator of calcium uptake within the myocyte. We will test the hypothesis that Istaroxime will improve diastolic function during exercise in HFpEF patients which in turn will reduce cardiac and pulmonary congestion.

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Full Description

About half of all elderly patients with a diagnosis of congestive heart failure have apparently normal systolic function, so called "heart failure with a preserved ejection fraction" or HFpEF. To date, no effective therapy for HFpEF has been found, in part because of failure to discern key pathophysiologic pathways.

An extensive amount of pre-clinical work has identified that altered sarcoplasmic reticulum (SR) Ca2+ uptake, storage, and release play a major role in the changes in cardiac relaxation associated with aging, especially regarding sequestration of Ca++ by the sarcoplasmic reticular Ca++-ATPase (SERCA2a), which causes cardiac muscle relaxation by reducing cytosolic Ca++. Istaroxime is a relatively new drug that augments lusitropic function by upregulating SERCA2a activity in the heart.

Because of the clear importance of slowed relaxation in HFpEF, and the evidence that depressed SERCA2a activity contributes to the slowed relaxation with aging, the proposed study may be establish the "impairment of SERCA2a" hypothesis as a mechanism of impaired relaxation in HFpEF subjects.

View Eligibility Criteria

Eligibility Criteria

Healthy Senior Controls

Inclusion Criteria:

age > 60 years

Exclusion Criteria:

Coronary Ischemia
No chronic medical problems
BMI > 30 kg/m2

HFpEF Subjects

Inclusion Criteria:

age > 60 years
signs and symptoms of heart failure
ejection fraction > 50%
objective evidence of diastolic dysfunction

Exclusion Criteria:

Coronary Ischemia
Chronic Kidney Disease, stage 4 or greater
Persistent atrial fibrillation
Severe valvular disease
BMI > 45 kg/m2

Study is for people with:

Heart Failure

Phase:

Early Phase 1

Estimated Enrollment:

26

Study ID:

NCT02772068

Recruitment Status:

Completed

Sponsor:

Benjamin Levine

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There is 1 Location for this study

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The Institute for Exercise and Environmental Medicine
Dallas Texas, 75231, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Early Phase 1

Estimated Enrollment:

26

Study ID:

NCT02772068

Recruitment Status:

Completed

Sponsor:


Benjamin Levine

How clear is this clinincal trial information?

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