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Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a

NCT02772068 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-06-29

No results posted yet for this study

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.

Conditions

  • Heart Failure, Congestive

Interventions

DRUG

Istaroxime

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

OTHER

Exercise

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Benjamin Levine

    lead OTHER

Principal Investigators

  • Benjamin D Levine, MD · UT Southwestern

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-15
Primary Completion
2018-12-01
Completion
2018-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02772068 on ClinicalTrials.gov