Diastolic Heart FailureNCT06015776
Purinergic Signaling and the Postmenopausal Heart
An observational study of Diastolic Heart Failure and Heart Failure With Preserved Ejection Fraction, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 88 years
- Conditions the study is for
- Diastolic Heart Failure, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Gender
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting for elective cardiac surgery. Patients will be enrolled and consented during hospital admission for surgery.
Who may be able to join
- Patients undergoing cardiac surgery under cardiopulmonary bypass.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Robina Matyal, MD, 6176401208, rmatyal1@bidmc.harvard.edu
About this study
Official title: PGC-1, Purines and the Postmenopausal Heart
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.
Read the detailed description
Cardiovascular disease (CVD) is the leading cause of death of women in the United States, accounting for around 1 of every 3 deaths. Estrogen deficiency, as seen in aging women or after oophorectomy, has been linked to loss of cardiovascular protection, typically seen during reproductive life. Up to half of women evaluated for myocardial ischemia have normal appearing coronary arteries. These women can develop heart failure with a preserved ejection fraction (termed HFpEF) for which the etiology is unclear. Hormonal replacement therapy (HRT) after menopause remains controversial but current evidence cannot support this for either primary or secondary prevention of CVD. There are clearly modulatory influences on estrogenic signaling, that could well influence cardiovascular health in later life. Previous studies have demonstrated that estrogen improves energy production within the heart by increasing 5' adenosine monophosphate-activated protein (AMPK) and mitochondrial biogenesis via upregulation of peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α); a master switch of mitochondrial function, linked to vascular integrity and angiogenesis. Estrogen has been also found to modulate purinergic signaling by boosting expression of adenosine receptors and of CD39, the dominant endothelial ecto-ADPase that generates adenosine. There are also close relationships between purinergic signaling and dipeptidyl peptidase-4 (DPP-4; otherwise known as adenosine deaminase complexing protein 2 or CD26), possibly mediated by adenosine deaminase bioactivity. Decreased PGC-1α and aberrant purinergic signaling in metabolic syndrome may lead to impaired mitochondrial function, provoking diastolic dysfunction, and also result in impaired angiogenesis. The investigators hypothesize there are central roles of PGC-1α, purines and DPP-4 linked neuropeptide pathways in the control of angiogenesis and mitochondrial activity. These become increasingly disordered in setting of estrogen loss provoking development of metabolic syndrome, thereby exacerbating HFpEF and microvascular disease. Specific Aim 1: To determine how ischemia and cardiometabolic dysfunction in women's heart disease are exacerbated by the loss of puringeric pathways from estrogen deficiency. The investigators expect to determine that diastolic dysfunction is a functional consequence of this microvascular loss and cardiometabolic dessynchrony. Specific Aim 2: To evaluate the role of adenosingergic receptor activation and DPPIV inhibition on angiogenesis in a ovariectomized swine model of chronic myocardial ischemia and metabolic syndrome. Here, the investigators will explore relationships between the regulated and linkages in the exocytosis of nucleotides and neuropeptides, formation of nucleosides (adenosine) and alterations in angiogenic activity secondary to these. Summary: The investigators will study fundamental mechanisms in heart disease underpinning biological differences in women. The investigators will also offer new therapeutic strategies that target cardiac metabolism.
- Being tested
- Gender
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenderOther
Differences between men and women will be observed
| Study group | Role | What they receive |
|---|---|---|
| Men | Men who are undergoing cardiac surgery Receives: Other: Gender | |
| Women | Women who are undergoing cardiac surgery Receives: Other: Gender |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative quantification of expression of CD39 and adenosinergic receptors
Expression of CD39, ADORA2A and ADORA2B in cardiac tissue measured using Western blotting
Measured: 6 months
Comparative quantification of expression of PGC-1 alpha, mitochondrial markers
Expression of PGC-1 alpha, AMPK and mitochondrial markers using Western blot
Measured: 6 months
Comparative quantification of expression of angiogenic markers
Expression of angiogenic markers (PDGF, VEGF, Angiostatin)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Jul 2019
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic Heart FailureStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robina Matyal, Beth Israel Deaconess Medical Center
- Investigators
- Robina Matyal, MD, Principal investigator, Beth Israel Deaconess Medical Center, Professor of AnesthesiaSimon Robson, MD, PhD, Principal investigator, Beth Israel Deaconess Medical Center,Vice Chair Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015776
- Sponsor's protocol ID
- 2008P000151/13
- Status last verified
- Jan 2026
- First submitted
- 23 Aug 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PGC-1, Purines and the Postmenopausal Heart
- ClinicalTrials.gov ID
- NCT06015776
- Acronym / sponsor ID
- 2008P000151/13
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiovascular disease (CVD) is the leading cause of death of women in the United States, accounting for around 1 of every 3 deaths. Estrogen deficiency, as seen in aging women or after oophorectomy, has been linked to loss of cardiovascular protection, typically seen during reproductive life. Up to half of women evaluated for myocardial ischemia have normal appearing coronary arteries. These women can develop heart failure with a preserved ejection fraction (termed HFpEF) for which the etiology is unclear. Hormonal replacement therapy (HRT) after menopause remains controversial but current evidence cannot support this for either primary or secondary prevention of CVD. There are clearly modulatory influences on estrogenic signaling, that could well influence cardiovascular health in later life. Previous studies have demonstrated that estrogen improves energy production within the heart by increasing 5' adenosine monophosphate-activated protein (AMPK) and mitochondrial biogenesis via upregulation of peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α); a master switch of mitochondrial function, linked to vascular integrity and angiogenesis. Estrogen has been also found to modulate purinergic signaling by boosting expression of adenosine receptors and of CD39, the dominant endothelial ecto-ADPase that generates adenosine. There are also close relationships between purinergic signaling and dipeptidyl peptidase-4 (DPP-4; otherwise known as adenosine deaminase complexing protein 2 or CD26), possibly mediated by adenosine deaminase bioactivity. Decreased PGC-1α and aberrant purinergic signaling in metabolic syndrome may lead to impaired mitochondrial function, provoking diastolic dysfunction, and also result in impaired angiogenesis. The investigators hypothesize there are central roles of PGC-1α, purines and DPP-4 linked neuropeptide pathways in the control of angiogenesis and mitochondrial activity. These become increasingly disordered in setting of estrogen loss provoking development of metabolic syndrome, thereby exacerbating HFpEF and microvascular disease. Specific Aim 1: To determine how ischemia and cardiometabolic dysfunction in women's heart disease are exacerbated by the loss of puringeric pathways from estrogen deficiency. The investigators expect to determine that diastolic dysfunction is a functional consequence of this microvascular loss and cardiometabolic dessynchrony. Specific Aim 2: To evaluate the role of adenosingergic receptor activation and DPPIV inhibition on angiogenesis in a ovariectomized swine model of chronic myocardial ischemia and metabolic syndrome. Here, the investigators will explore relationships between the regulated and linkages in the exocytosis of nucleotides and neuropeptides, formation of nucleosides (adenosine) and alterations in angiogenic activity secondary to these. Summary: The investigators will study fundamental mechanisms in heart disease underpinning biological differences in women. The investigators will also offer new therapeutic strategies that target cardiac metabolism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men | – | Other: GenderMen who are undergoing cardiac surgery |
| Women | – | Other: GenderWomen who are undergoing cardiac surgery |
Who may qualify
- Ages
- 30 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for elective cardiac surgery. Patients will be enrolled and consented during hospital admission for surgery.
Key inclusion criteria (1 listed)
- Patients undergoing cardiac surgery under cardiopulmonary bypass.
Key exclusion criteria (8 listed)
- Refusal to participate
- Emergency surgery
- Pre-existing heart block
- Preexisting atrial fibrillation
- Redo surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenderDifferences between men and women will be observed | Other | Men, Women |
Primary outcome
Comparative quantification of expression of CD39 and adenosinergic receptors
Time frame: 6 months
Expression of CD39, ADORA2A and ADORA2B in cardiac tissue measured using Western blotting
Comparative quantification of expression of PGC-1 alpha, mitochondrial markers
Time frame: 6 months
Expression of PGC-1 alpha, AMPK and mitochondrial markers using Western blot
Comparative quantification of expression of angiogenic markers
Time frame: 6 months
Expression of angiogenic markers (PDGF, VEGF, Angiostatin)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robina Matyal, MD principal investigator
Beth Israel Deaconess Medical Center, Professor of Anesthesia
Simon Robson, MD, PhD principal investigator
Beth Israel Deaconess Medical Center,Vice Chair Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diastolic Heart Failure and Heart Failure With Preserved Ejection Fraction, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robina Matyal, MD (6176401208, rmatyal1@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative quantification of expression of CD39 and adenosinergic receptors (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.