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Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure

ConditionsHeart Failure With Normal Ejection FractionHeart Failure With Reduced Ejection FractionHeart Failure, Right SidedHeart Failure With Mid Range Ejection FractionCardiovascular Risk Factor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

18 years and older

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

Disqualifiers

None

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

3,000 Participants
are grouped into 3 trial groups
Group A: Control
Group B: Heart Failure w/NormalEjectionFraction
Group C: HeartFailure w/ReducedEjectionFraction

Trial outcomes

Primary outcomes

1

Major adverse cardiovascular events (MACE)

MACE as defined by a combined end point of all-cause mortality and HF hospitalizations.

Time frame
Time from sample collection until the date of documented event up to 60 months after the study closure.

Secondary outcomes

1

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 frame
Time from sample collection until the date of documented event up to 60 months after the study closure.
2

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 frame
Time from sample collection until the date of documented event up to 60 months after the study closure.
3

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 frame
Time from sample collection until the date of documented event up to 60 months after the study closure.
4

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 frame
Time from sample collection until the date of documented event up to 60 months after the study closure.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Roche Diagnostics GmbH

Collaborator

Source ClinicalTrials.gov
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