Purinergic Signaling and the Postmenopausal Heart

NCT06015776 | Recruiting

• 1 other identifier: 2008P000151/13
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Heart Failure With Preserved Ejection Fraction; Diastolic Heart Failure

Outcome Measures

Primary Outcomes (3)

• Comparative quantification of expression of CD39 and adenosinergic receptors

  Expression of CD39, ADORA2A and ADORA2B in cardiac tissue measured using Western blotting

  6 months

• Comparative quantification of expression of PGC-1 alpha, mitochondrial markers

  Expression of PGC-1 alpha, AMPK and mitochondrial markers using Western blot

  6 months

• Comparative quantification of expression of angiogenic markers

  Expression of angiogenic markers (PDGF, VEGF, Angiostatin)

  6 months

Study Arms (2)

Men

Men who are undergoing cardiac surgery

Other: Gender

Women

Women who are undergoing cardiac surgery

Other: Gender

Interventions

Gender OTHER

Differences between men and women will be observed

Men; Women

Eligibility Criteria

• Age: 30 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for elective cardiac surgery. Patients will be enrolled and consented during hospital admission for surgery.

You may qualify if:

• Patients undergoing cardiac surgery under cardiopulmonary bypass.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Atrial tissue containing atrial myocytes is snap frozen in liquid nitrogen and stored. Serum samples are also collected.

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

Sex

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Robina Matyal, MD

  Beth Israel Deaconess Medical Center, Professor of Anesthesia

  PRINCIPAL INVESTIGATOR

• Simon Robson, MD, PhD

  Beth Israel Deaconess Medical Center,Vice Chair Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robina Matyal, MD

CONTACT

6176401208; rmatyal1@bidmc.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: July 1, 2019
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: March 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)