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

• ClinicalTrials.gov Identifier: NCT03480633
• Recruitment Status: Recruiting
• First Posted: March 29, 2018
• Last Update Posted: January 25, 2021
• Sponsor: Massachusetts General Hospital
• Collaborator: Substudy funding: Roche diagnostics
• Information provided by (Responsible Party): Hanna Kim Gaggin, Massachusetts General Hospital

Study Description

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.

Study Design

• 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

Groups and Cohorts

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%.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Asher Bean, MD; 617-726-2709; AJBEAN@PARTNERS.ORG

Contact: Neyat Fiseha, BS; 617-726-2709; NFISEHA@mgh.harvard.edu

Locations

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

• Principal Investigator: Hanna Gaggin, MD, MPH; Massachusetts General Hospital

More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Abboud A, Nguonly A, Bean A, Brown KJ, Chen RF, Dudzinski D, Fiseha N, Joice M, Kimaiyo D, Martin M, Taylor C, Wei K, Welch M, Zlotoff DA, Januzzi JL, Gaggin HK. Rationale and design of the preserved versus reduced ejection fraction biomarker registry and precision medicine database for ambulatory patients with heart failure (PREFER-HF) study. Open Heart. 2021 Oct;8(2). pii: e001704. doi: 10.1136/openhrt-2021-001704.

• 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
• Last Update Posted: January 25, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Heart Failure; Heart Diseases; Cardiovascular Diseases