Heart Failure, Congestive Clinical Trial
Official title:
Hemodynamic Response to Exercise in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients After Upregulation of SERCA2a
Verified date | June 2022 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | December 1, 2018 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | The Institute for Exercise and Environmental Medicine | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Benjamin Levine | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in cardiac filling pressures (pulmonary capillary wedge pressure) during exercise with Istaroxime | Change in cardiac filling pressures (pulmonary capillary wedge pressure) during exercise with Istaroxime | Immediate; 90 minutes after infusion | |
Secondary | Change in cardiac relaxation time (isovolumic relaxation time) during exercise with Istaroxime | Change in cardiac relaxation time (isovolumic relaxation time) during exercise | 90 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
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