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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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%

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Abbie Macher, BS
ajmacher@mgh.harvard.edu
617-643-6328
Backup
Laura Stockhausen, BS
lstockhausen@mgh.harvard.edu
617-724-1339
Time Frame
Start Date: 2016-04-07
Estimated Completion Date: 2027-10-06
Participants
Target number of participants: 3000
Treatments
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%.
Related Therapeutic Areas
Sponsors
Collaborators: Roche Diagnostics GmbH
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov