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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02772068
Other study ID # STU 042013-039
Secondary ID R01AG017479
Status Completed
Phase Early Phase 1
First received
Last updated
Start date September 15, 2015
Est. completion date December 1, 2018

Study information

Verified date June 2022
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Istaroxime
Subjects will be given Istaroxime, a novel SERCA2a activator one hour prior and during exercise.
Other:
Exercise


Locations

Country Name City State
United States The Institute for Exercise and Environmental Medicine Dallas Texas

Sponsors (2)

Lead Sponsor Collaborator
Benjamin Levine National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

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
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