NCT02772068

Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a

Completed EARLY_PHASE1 Last updated 29 June 2022

What this trial tests

EARLY_PHASE1 trial testing Istaroxime in Heart Failure, Congestive in 26 participants. Completed in 1 December 2018.

Timeline

15 September 2015

Primary endpoint
1 December 2018

1 December 2018

Quick facts

Lead sponsor	Benjamin Levine
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	26
Start date	15 September 2015
Primary completion	1 December 2018
Estimated completion	1 December 2018
Sites	1 location across United States

Drugs / interventions tested

• Istaroxime — full drug profile →
• Exercise

Conditions studied

• Heart Failure, Congestive — all drugs for Heart Failure, Congestive →

Sponsor

Benjamin Levine

Who can join

Adults 60 to 85, any sex, with Heart Failure, Congestive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Correcting Calcium Dysregulation in Chronic Heart Failure Using SERCA2a Gene Therapy.
   Samuel TJ, Rosenberry RP, Lee S, Pan Z. · · 2018 · cited 33× · PMID 29621141 · DOI 10.3390/ijms19041086
2. Drug Targets for Heart Failure with Preserved Ejection Fraction: A Mechanistic Approach and Review of Contemporary Clinical Trials.
   Patel RB, Shah SJ. · · 2019 · cited 27× · PMID 30296895 · DOI 10.1146/annurev-pharmtox-010818-021136
3. SERCA2a Agonist Effects on Cardiac Performance During Exercise in Heart Failure With Preserved Ejection Fraction.
   Sarma S, MacNamara JP, Hieda M, Howden EJ, et al · · 2023 · cited 10× · PMID 37086245 · DOI 10.1016/j.jchf.2023.02.006
4. SERCA2a dysfunction in the pathophysiology of heart failure with preserved ejection fraction: a direct role is yet to be established.
   Shooshtarian AK, O'Gallagher K, Shah AM, Zhang M. · · 2025 · cited 7× · PMID 39843817 · DOI 10.1007/s10741-025-10487-1
5. New Opportunities in Heart Failure with Preserved Ejection Fraction: From Bench to Bedside… and Back.
   Parra-Lucares A, Romero-Hernández E, Villa E, Weitz-Muñoz S, et al · · 2022 · cited 1× · PMID 36672578 · DOI 10.3390/biomedicines11010070