RECRUITING

HeartShare: Combining Omics, Deep Phenotyping, and Electronic Health Records for Heart Failure Subtypes and Treatment Targets

Conditions

Heart Failure Heart Failure With Preserved Ejection Fraction

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

HeartShare is a comprehensive study of heart failure, a common and serious medical condition which occurs when the heart is unable to keep up with the demands of the body, resulting in shortness of breath, fluid retention, and fatigue. HeartShare aims to better classify heart failure into subtypes to help develop more personalized treatments for patients, with the hope that this will improve the lives of heart failure patients. To do this, HeartShare is bringing together a large amount of data (including images, such as heart ultrasounds and MRIs and molecular data from the blood, such as genetics) from previously conducted studies and electronic health records, and is gathering new data through participants enrolled in the HeartShare Deep Phenotyping Study.

Official Title

HeartShare Deep Phenotyping Study

Quick Facts

Study Start:2023-03-01

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05873634

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥30 years. 2. Prior diagnosis of HF in the EHR (any left ventricular ejection fraction). 1. Age ≥30 years. 2. No known prior diagnosis of HF or use of loop diuretics. 3. No known prior history of BNP \>100 pg/ml or NTproBNP \>300 pg/ml, if prior laboratory tests are available in the EHR. 1. Age ≥30 years. 2. Left ventricular ejection fraction ≥50% measured by echocardiography. 3. Definition of HFpEF: signs and symptoms of HF, NYHA functional class II-IV, and at least one of the following: 1. Elevated BNP (≥75 pg/ml in sinus rhythm or ≥225 pg/ml in atrial fibrillation/flutter) or NTproBNP (≥225 pg/ml in sinus rhythm or ≥675 in atrial fibrillation/flutter) at baseline. Choice of BNP or NTproBNP is based on availability at each clinical center. 2. Prior HF hospitalization (primary reason for the hospitalization is HF with elevated natriuretic peptide levels \[using the thresholds listed above\], requiring IV diuresis for HF, or pulmonary edema or pulmonary vascular congestion on chest radiography). 3. Elevated pulmonary capillary wedge pressure (PCWP) at rest (≥15 mmHg) or during exercise (≥25 mmHg for supine exercise or PCWP/cardiac output ratio ≥2 mmHg/L/min for upright exercise). 4. Elevated H2FPEF score26 (≥5) or HFA-PEFF27 score (≥5). 1. Age ≥30 years. 2. Left ventricular ejection fraction ≥50% measured by echocardiography. 3. No known prior diagnosis of HF or use of diuretics for fluid management. 4. No known prior history of BNP ≥75 pg/ml or NTproBNP ≥225 pg/ml, if prior laboratory tests are available in the EHR. 5. BNP \<75 pg/ml or NTproBNP \<225 pg/ml at the time of screening. Choice of BNP or NTproBNP is based on availability at each clinical center.	1. For non-HF group: any prior known left ventricular ejection fraction \<50%. 2. Prior history of solid organ transplantation. 3. Prior history of mechanical circulatory support. 4. Prior history of non-cardiac cirrhosis. 5. Inability to provide written consent to the study. 1. Life expectancy estimated to be \< 1 year. 2. Primary cardiomyopathy (including amyloid, hypertrophic cardiomyopathy, cardiac sarcoidosis, hemochromatosis, or other infiltrative cardiomyopathies) or pulmonary arterial hypertension (WHO Group I, III, or IV pulmonary hypertension). 3. Any prior known left ventricular ejection fraction \<40%, except if this occurred only in the setting of an acute tachycardia episode (e.g., acute atrial fibrillation). 4. Clinically significant valvular heart disease defined as: 1. Moderate to greater aortic stenosis, pulmonic stenosis, or tricuspid stenosis. 2. Any mitral stenosis. 3. Moderate or greater aortic regurgitation. 4. Greater than moderate mitral regurgitation. 5. Any planned cardiac surgery or cardiac intervention in the next 3 months. 6. Alternative primary reason for symptoms of shortness of breath and exercise intolerance in HFpEF participants in the opinion of the enrolling investigator. 7. Cardiac surgery, acute coronary syndrome, percutaneous coronary intervention, stroke, transient ischemic attack, or carotid intervention in the preceding 6 months prior to enrollment. 8. Known symptomatic epicardial coronary artery disease that is not revascularized. 9. Any non-elective hospitalization in the preceding 2 weeks. 10. Prior history of solid organ transplantation. 11. Prior history of chronic infection (HIV, hepatitis C, hepatitis B, tuberculosis) unless treated and not clinically active in the opinion of the enrolling investigator. 12. Prior history of mechanical circulatory support. 13. Prior history of non-cardiac cirrhosis. 14. Estimated GFR \<20 ml/min/1.73m2 or currently on dialysis. 15. Any condition that may preclude participation or adherence to the study protocol, in the opinion of the enrolling investigator. 16. Inability to provide written consent to the study. 17. Current acute decompensated heart failure. 18. Currently pregnant.

Inclusion Criteria

Exclusion Criteria

1. Age ≥30 years.
2. Prior diagnosis of HF in the EHR (any left ventricular ejection fraction).
1. Age ≥30 years.
2. No known prior diagnosis of HF or use of loop diuretics.
3. No known prior history of BNP \>100 pg/ml or NTproBNP \>300 pg/ml, if prior laboratory tests are available in the EHR.
1. Age ≥30 years.
2. Left ventricular ejection fraction ≥50% measured by echocardiography.
3. Definition of HFpEF: signs and symptoms of HF, NYHA functional class II-IV, and at least one of the following:
1. Elevated BNP (≥75 pg/ml in sinus rhythm or ≥225 pg/ml in atrial fibrillation/flutter) or NTproBNP (≥225 pg/ml in sinus rhythm or ≥675 in atrial fibrillation/flutter) at baseline. Choice of BNP or NTproBNP is based on availability at each clinical center.
2. Prior HF hospitalization (primary reason for the hospitalization is HF with elevated natriuretic peptide levels \[using the thresholds listed above\], requiring IV diuresis for HF, or pulmonary edema or pulmonary vascular congestion on chest radiography).
3. Elevated pulmonary capillary wedge pressure (PCWP) at rest (≥15 mmHg) or during exercise (≥25 mmHg for supine exercise or PCWP/cardiac output ratio ≥2 mmHg/L/min for upright exercise).
4. Elevated H2FPEF score26 (≥5) or HFA-PEFF27 score (≥5).
1. Age ≥30 years.
2. Left ventricular ejection fraction ≥50% measured by echocardiography.
3. No known prior diagnosis of HF or use of diuretics for fluid management.
4. No known prior history of BNP ≥75 pg/ml or NTproBNP ≥225 pg/ml, if prior laboratory tests are available in the EHR.
5. BNP \<75 pg/ml or NTproBNP \<225 pg/ml at the time of screening. Choice of BNP or NTproBNP is based on availability at each clinical center.

1. For non-HF group: any prior known left ventricular ejection fraction \<50%.
2. Prior history of solid organ transplantation.
3. Prior history of mechanical circulatory support.
4. Prior history of non-cardiac cirrhosis.
5. Inability to provide written consent to the study.
1. Life expectancy estimated to be \< 1 year.
2. Primary cardiomyopathy (including amyloid, hypertrophic cardiomyopathy, cardiac sarcoidosis, hemochromatosis, or other infiltrative cardiomyopathies) or pulmonary arterial hypertension (WHO Group I, III, or IV pulmonary hypertension).
3. Any prior known left ventricular ejection fraction \<40%, except if this occurred only in the setting of an acute tachycardia episode (e.g., acute atrial fibrillation).
4. Clinically significant valvular heart disease defined as:
1. Moderate to greater aortic stenosis, pulmonic stenosis, or tricuspid stenosis.
2. Any mitral stenosis.
3. Moderate or greater aortic regurgitation.
4. Greater than moderate mitral regurgitation.
5. Any planned cardiac surgery or cardiac intervention in the next 3 months.
6. Alternative primary reason for symptoms of shortness of breath and exercise intolerance in HFpEF participants in the opinion of the enrolling investigator.
7. Cardiac surgery, acute coronary syndrome, percutaneous coronary intervention, stroke, transient ischemic attack, or carotid intervention in the preceding 6 months prior to enrollment.
8. Known symptomatic epicardial coronary artery disease that is not revascularized.
9. Any non-elective hospitalization in the preceding 2 weeks.
10. Prior history of solid organ transplantation.
11. Prior history of chronic infection (HIV, hepatitis C, hepatitis B, tuberculosis) unless treated and not clinically active in the opinion of the enrolling investigator.
12. Prior history of mechanical circulatory support.
13. Prior history of non-cardiac cirrhosis.
14. Estimated GFR \<20 ml/min/1.73m2 or currently on dialysis.
15. Any condition that may preclude participation or adherence to the study protocol, in the opinion of the enrolling investigator.
16. Inability to provide written consent to the study.
17. Current acute decompensated heart failure.
18. Currently pregnant.

Contacts and Locations

Study Contact

Laura Alagna

CONTACT

312-695-6765

heartsharestudy@northwestern.edui

Principal Investigator

Sanjiv Shah, MD

PRINCIPAL_INVESTIGATOR

Northwestern University

Svati Shah, MD, MHS

STUDY_CHAIR

Duke University

Javed Butler, MPH, MBA

STUDY_CHAIR

Baylor Scott and White Health

Study Locations (Sites)

University of California Davis

Sacramento, California, 95817

United States

Northwestern University

Chicago, Illinois, 60611

United States

Mass General Brigham

Boston, Massachusetts, 02114

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Wake Forest University

Winston-Salem, North Carolina, 27157

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Northwestern University

Sanjiv Shah, MD, PRINCIPAL_INVESTIGATOR, Northwestern University
Svati Shah, MD, MHS, STUDY_CHAIR, Duke University
Javed Butler, MPH, MBA, STUDY_CHAIR, Baylor Scott and White Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01

Study Completion Date2026-06

Study Record Updates

Study Start Date2023-03-01

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure
Heart Failure With Preserved Ejection Fraction