Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure

Cardiovascular Risk Factor Clinical Trial

— PREFER-HF  

Official title:

Preserved vs. Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Heart Failure Patients (PREFER-HF) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03480633
• Other study ID #: 2016P000339
• Status: Recruiting
• Start date: April 7, 2016
• Est. completion date: October 6, 2027

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Abbie Macher, BS
• Phone: 617-643-6328
• Email: ajmacher[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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) and cardiomyopathies including amyloidosis 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.

Description:

Patients 18-years and older with and without heart failure (across all left ventricular ejection fraction) and cardiomyopathies including amyloidosis 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: October 6, 2027
• Est. primary completion date: April 6, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Heart Failure
• Heart Failure With Mid Range Ejection Fraction
• Heart Failure With Normal Ejection Fraction
• Heart Failure With Reduced Ejection Fraction
• Heart Failure, Right Sided

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Roche Diagnostics GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular events (MACE)	MACE as defined by a combined end point of all-cause mortality and HF hospitalizations.	Time from sample collection until the date of documented event up to 60 months after the study closure.
Secondary	Time to event: all-cause mortality	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.	Time from sample collection until the date of documented event up to 60 months after the study closure.
Secondary	Time to event: cardiovascular mortality	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.	Time from sample collection until the date of documented event up to 60 months after the study closure.
Secondary	Time to event: all-cause hospitalization	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.	Time from sample collection until the date of documented event up to 60 months after the study closure.
Secondary	Time to event: cardiovascular hospitalization	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.	Time from sample collection until the date of documented event up to 60 months after the study closure.
Secondary	Time to event: HF hospitalization	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.	Time from sample collection until the date of documented event up to 60 months after the study closure.
Secondary	Time to event: Right-sided HF	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.	Time from sample collection until the date of documented event up to 60 months after the study closure.
Secondary	Time to event: acute kidney injury	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.	Time from sample collection until the date of documented event up to 60 months after the study closure.