Cardiovascular

Test to Treat

Posted on by Jodi Snare

Study Updated: 04/12/2024

Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Neha Pagidipati
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: Amgen
Funding Date: 2023
Study Duration: 2023 – 2025
Participating Clinical Research Networks: GPC, PaTH, REACHnet, STAR
Therapeutic Area: Cardiovascular
Condition: Atherosclerotic Cardiovascular Disease (ASCVD)

Research Question(s): Can improved coordination of care between inpatient and outpatient teams working with ASCVD patients help prevent another cardiovascular event within one year in this high-risk population?

TBD: Improving LDLC management in underrepresented populations

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Neha Pagidipati
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: Novartis
Funding Date: 2023
Study Duration: 2023 – 2025
Participating Clinical Research Networks: GPC, OneFlorida+, PaTH, REACHnet, STAR 
Therapeutic Area: Cardiovascular
Condition: Atherosclerotic Cardiovascular Disease (ASCVD)
Status: Not yet recruiting

Research Question(s):
Can inclisiran be an effective solution to improve low-density lipoprotein-cholesterol management and close care gaps in an inclusive Atherosclerotic Cardiovascular Disease (ASCVD) and ASCVD risk equivalent population?

Cardiovascular Multicenter Observational Investigation of Lipid Care in the United States-2 (cvMOBIUS2)

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Eric Peterson, Ann Marie Navar
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: Amgen
Funding Date: 2021
Study Duration: 2021 – 2026
Participating Clinical Research Networks: GPC, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Cardiovascular
Condition: Atherosclerotic Cardiovascular Disease (ASCVD)
Population: 18 Years and older (Adult, Older Adult)
Status: Active, not recruiting

Research Question(s):

  1. Can we reduce the number of people who die from atherosclerotic cardiovascular disease (ASCVD) related deaths by using PCSK9 medicines to lower their cholesterol?

Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term (ADAPTABLE)

Posted on by Jodi Snare

Study Updated 03/04/2024

Study Website: ADAPTABLE
ClinicalTrials.gov#: NCT02697916
Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM (+ supplemental data), Engagement, Single IRB (hybrid)
Principal Investigator: Matt Roe, then William Jones
Site Name: Duke University
PCORnet® Network Partner: STAR
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2015
Study Duration: 2016 – 2020
Participating Clinical Research Networks: ADVANCE, GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Cardiovascular
Condition: Atherosclerotic Cardiovascular Disease (ASCVD)
Population: 18 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s):
Which dose of daily aspirin offers the right balance of effectiveness and minimal risk of bleeding? Can PCORnet be used to find the answer using a clinical trial model wherein patients are drivers of engagement?

Primary Publication(s):
Rationale and Design of the Aspirin Dosing-A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) Trial
Marquis-Gravel G, Roe MT, Robertson HR, et al. Rationale and design of the apsirin dosing- a patient-centric trial asessing benefits and long-term effectiveness (ADAPTABLE) Trial. JAMA Cardiol, 2020; 5(5): 598-607.

Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease
Jones WS, Mulder H, Wruck LM, et al. Comparative effectiveness of aspirin dosing in cardiovascular disease. N Engl J Med, 2021; 384(21); 1981-1990.

Characterization of Patients with Heart Failure and Patients with Atrial Fibrillation and Atrial Flutter in PCORnet Data

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Manesh Patel
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: Bayer
Funding Date: 2020
Study Duration: 2020 – 2025
Participating Clinical Research Networks: GPC, STAR
Therapeutic Area: Cardiovascular
Condition: Congestive Heart Failure
Population: 18 Years and older (Adult,  Older Adult )
Status: Completed

Research Question(s):
What is the occurrence of vascular, bleeding, or other events in Atrial Fibrillation or Atrial Flutter Patients patients?

Primary Publication(s):
Electronic Health Record Characterization and Outcomes of Heart Failure with Preserved Ejection Fraction
Rao VN, Cyr D, Wruck L, et al. Electronic health record characterization and outcomes of heart failure with preserved ejection fraction. American Heart Journal. 2023. In press, journal pre-proof.

Using PCORnet to Compare Blood Pressure Control Strategies

Posted on by Jodi Snare

Study Updated 03/06/2024

Study Website: Using PCORnet to Compare Blood Pressure Control Strategies
ClinicalTrials.gov#: NCT03796689
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement
Principal Investigator: Mark Pletcher
Site Name: University of California, San Francisco
PCORnet® Network Partner: REACHnet
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2018
Study Duration: 2018 – 2023
Participating Clinical Research Networks:ADVANCE, GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Cardiovascular
Condition: Hypertension
Population: 18 Years and older (Adult,  Older Adult)
Status: Completed

Research Question(s):
How well are clinics and patients controlling blood pressure, and would new programs or technologies help improve blood pressure control?

Primary Publication(s):
Tracking Blood Pressure Control Performance and Process Metrics in 25 US Health Systems: The PCORnet Blood Pressure Control Laboratory
Cooper-DeHoff RM, Fontil V, Carton T, et al. Tracking blood pressure control performance and process metrics in 25 US health systems: The PCORnet Blood Pressure Control Laboratory. J Am Heart Assoc, 2021; 10(21): e022224.

Empagliflozin Diabetic Kidney Disease (Empa DKD)

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Neha Pagidipati
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: Boehringer Ingelheim
Funding Date: 2021
Study Duration: 2021 – 2024
Participating Clinical Research Networks: OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Cardiovascular
Condition: Diabetes/Cardiovascular
Population: 18 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s):

  1. Can we better understand why patients with type-2 diabetes may not receive guideline-recommended screening for diabetic kidney disease?
  2. Which medications may be most effective at improving kidney and heart outcomes in patients with and without type-2 diabetes?

PRECIDENTD – PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Website: PRECIDENTD
ClinicalTrials.gov#: NCT05390892
Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Brendan Everett
Site Name: Brigham and Women’s Hospital
PCORnet® Network Partner: External
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2021
Study Duration: 2022 – 2028
Participating Clinical Research Networks: GPC, INSIGHT, PaTH, STAR
Therapeutic Area: Cardiovascular
Condition: Type2Diabetes; Atherosclerotic Cardiovascular Disease (ASCVD)
Population: 40 Years to 80 Years (Adult, Older Adult)
Status: Recruiting

Research Question(s):

  1. In patients with type 2 diabetes, are SGLT2 inhibitors or GLP-1 recent agonists better for preventing heart attack, stroke, blood vessel disease, heart failure, kidney disease, and death?
  2. Is combination therapy with both medication classes better than one therapy alone?

Utilizing PCORnet to support transition from pediatric to adult centered care and reduce gaps in recommended care in patients with congenital heart disease

Posted on by Jodi Snare

Study Updated 03/06/2024

Study Website: Congenital Heart Initiative
ClinicalTrials.gov#: NCT05185232
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Thomas Carton, Anitha John
Site Name: Louisiana Public Health Institute (LPHI)
PCORnet® Network Partner: REACHnet
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2021
Study Duration: 2021 – 2024
Participating Clinical Research Networks: INSIGHT, OneFlorida+, PEDSnet, REACHnet
Therapeutic Area: Cardiovascular
Condition: Congenital Heart Disease; Comorbidities and Coexisting Conditions
Population: 18 Years and older (Adult,  Older Adult)
Status: Active, not recruiting

Research Question(s):

  1. How does receiving current recommended care affect long-term outcomes and healthcare needs amongst the numerous rare disease subtypes of congenital heart defects?
  2. What factors are associated with gaps in recommended care?
  3. Do patients report feeling better when they remain in specialty care?

Implementation of Patient-Reported Outcomes Measurement in Routine Clinical Practice for Heart Patients in PCORnet

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Justin Bachmann
Site Name: Vanderbilt University Medical Center (VUMC)
PCORnet® Network Partner: STAR
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2017
Study Duration: 2019 – 2021
Participating Clinical Research Networks: PaTH, STAR
Therapeutic Area: Cardiovascular
Condition: Congestive Heart Failure
Population: 75 Years and older (Older Adult )
Status: Completed

Research Question(s):
Can PCORnet be leveraged to implement patient-reported outcome measures in routine clinical practice for heart failure patients at three different institutions?