Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a

• Status: Withdrawn
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center

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 > 40 kg/m2