Recruiting

Purinergic Signaling

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06015776

Conditions

Diastolic Heart Failure

Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Gender

Study Details

Brief summary:

There is an increased risk of diastolic heart failure in post menopausal women. Estrogen plays a positive role in regulating molecular pathways in heart remodeling. Such pathways may work through purinergic signaling and its downstream effects on the heart's mitochondrial metabolism and angiogenic response to stress. Loss of estrogen functionality in post menopausal women may account for the increased risk of diastolic heart failure. The investigators will explore said pathways using cardiac tissue obtained from patients undergoing cardiac surgery.

Conditions

Diastolic Heart Failure

Heart Failure With Preserved Ejection Fraction

Study ID

NCT06015776

Start date

Jul 1, 2019

Status verified date

Jan, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing cardiac surgery under cardiopulmonary bypass.

Exclusion Criteria:

  • Refusal to participate
  • Emergency surgery
  • Pre-existing heart block
  • Preexisting atrial fibrillation
  • Redo surgery
  • Estrogen or hormone replacement therapy
  • History of chronic heart failure
  • History of major kidney disease

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Men

Men who are undergoing cardiac surgery

Women

Women who are undergoing cardiac surgery

Interventions

Gender

Differences between men and women will be observed

Primary outcome measure

  • Comparative quantification of expression of CD39 and adenosinergic receptors [ Time Frame: 6 months ]
  • Comparative quantification of expression of PGC-1 alpha, mitochondrial markers [ Time Frame: 6 months ]
  • Comparative quantification of expression of angiogenic markers [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Robina Matyal, MD

6176401208rmatyal1@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Robina Matyal, MD

6176401208rmatyal1@bidmc.harvard.edu

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Mar 20, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-03-20.