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Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure (PREFER-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03480633
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : January 25, 2021
Sponsor:
Collaborator:
Substudy funding: Roche diagnostics
Information provided by (Responsible Party):
Hanna Kim Gaggin, Massachusetts General Hospital

Brief Summary:
In this single-center, longitudinal observational study, we will comprehensively examine clinical characteristics, proteomic, metabolomic, genomic and imaging data to better understand how different heart failure types may develop and progress over time. We will evaluate distinct sub-groups of heart failure (also known as heart failure phenotypes) with an ultimate goal of bringing the right medications and therapy to the right patients to optimize benefit and minimized side effects, an effort to improve precision medicine in heart failure.

Condition or disease
Heart Failure With Normal Ejection Fraction Heart Failure With Reduced Ejection Fraction Heart Failure, Right Sided Heart Failure With Mid Range Ejection Fraction Cardiovascular Risk Factor

Detailed Description:

Patients 18-years and older with and without heart failure (across all left ventricular ejection fraction) will be enrolled in this single center, longitudinal observational Registry.

Baseline and one-year follow up blood samples including DNA as well as clinical characteristics, events leading up to heart failure diagnosis, etiology of heart failure, the presence and duration of other medical problems, laboratory, echocardiographic data and images, and therapy information will be obtained.

Clinical outcomes of interest include major adverse cardiovascular events (a combination of all-cause death and heart failure hospitalizations), individual endpoints of all-cause death, cardiovascular death, all-cause hospitalization, cardiovascular hospitalization, heart failure hospitalization, right-sided heart failure, and kidney injury.

Results from the Preserved vs. Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Heart Failure Patients (PREFER-HF) trial will comprehensively examine longitudinal clinical characteristics, proteomic, metabolomic, genomic and imaging data to better understand pathophysiology of heart failure and phenotypes in heart failure with an ultimate goal of improving precision medicine in heart failure.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 50 Months
Official Title: Preserved vs. Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Heart Failure Patients (PREFER-HF) Study
Actual Study Start Date : April 7, 2016
Estimated Primary Completion Date : April 6, 2026
Estimated Study Completion Date : October 6, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort
Control
Defined as patients without a history of heart failure
Heart Failure w/NormalEjectionFraction
Heart Failure with Normal Ejection Fraction is defined as having a Left Ventricle Ejection Fraction of greater than or equal to 50%.
HeartFailure w/ReducedEjectionFraction
Heart Failure with Reduced Ejection Fraction is defined as having a Left Ventricle Ejection Fraction of less than 50%.



Primary Outcome Measures :
  1. Major adverse cardiovascular events (MACE) [ Time Frame: Time from sample collection until the date of documented event up to 60 months after the study closure. ]
    MACE as defined by a combined end point of all-cause mortality and HF hospitalizations.


Secondary Outcome Measures :
  1. Time to event: all-cause mortality [ Time Frame: Time from sample collection until the date of documented event up to 60 months after the study closure. ]
    Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events.

  2. Time to event: cardiovascular mortality [ Time Frame: Time from sample collection until the date of documented event up to 60 months after the study closure. ]
    Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events.

  3. Time to event: all-cause hospitalization [ Time Frame: Time from sample collection until the date of documented event up to 60 months after the study closure. ]
    Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events.

  4. Time to event: cardiovascular hospitalization [ Time Frame: Time from sample collection until the date of documented event up to 60 months after the study closure. ]
    Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events.

  5. Time to event: HF hospitalization [ Time Frame: Time from sample collection until the date of documented event up to 60 months after the study closure. ]
    Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events.

  6. Time to event: Right-sided HF [ Time Frame: Time from sample collection until the date of documented event up to 60 months after the study closure. ]
    Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events.

  7. Time to event: acute kidney injury [ Time Frame: Time from sample collection until the date of documented event up to 60 months after the study closure. ]
    Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events.


Biospecimen Retention:   Samples With DNA
Blood samples will be collected at baseline as well as at 1 year follow up. At both time points, a total blood volume of up to 50 mL will be collected using EDTA and serum tubes, while patients are seated. Samples will be spun at 1800 rpm and plasma aliquoted. Samples will be frozen immediately at -80 C. For patients who opt to participate in the genetic portion of this study, buffy coat aliquoting and processing will be executed using the same blood samples.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients will be identified and screened in inpatient units, via medical records, outpatient clinics, primary physician or specialist schedules, and through Research Patient Data Registry (RPDR).
Criteria

Inclusion criteria for patients with HF:

  • 18 years and older
  • History of clinical symptoms consistent with HF and at least one of the following supporting evidence of HF:

    • NT-proBNP > 125 pg/mL
    • BNP > 35 pg/mL
    • Capillary wedge pressure ≥ 15 mmHg on right heart catheterization or CI <2.8 L/min/m2
    • LVEDP ≥ 15 mmHg
    • Radiographic evidence of pulmonary edema
    • Improvement in symptoms with diuretic initiation of increase
    • CPET evidence of cardiac etiology of symptoms

HFpEF: LVEF ≥ 50% HFrEF: LVEF <50%

Exclusion criteria (for all patients, including both those with HFpEF and HFrEF):

- End stage renal disease on dialysis


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480633


Contacts
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Contact: Asher Bean, MD 617-726-2709 AJBEAN@PARTNERS.ORG
Contact: Neyat Fiseha, BS 617-726-2709 NFISEHA@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: NurAlima Grandison, BA         
Principal Investigator: Hanna Gaggin, MD, MPH         
Sponsors and Collaborators
Massachusetts General Hospital
Substudy funding: Roche diagnostics
Investigators
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Principal Investigator: Hanna Gaggin, MD, MPH Massachusetts General Hospital
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hanna Kim Gaggin, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03480633    
Other Study ID Numbers: 2016P000339
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hanna Kim Gaggin, Massachusetts General Hospital:
Heart failure
Precision medicine
High risk patients
Pathophysiology
Bioregistry
Biomarkers
Heart failure etiology
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases