Heart Failure With Normal Ejection FractionPREFER-HFNCT03480633
Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure
An observational study of Heart Failure With Normal Ejection Fraction and Heart Failure With Reduced Ejection Fraction, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Normal Ejection Fraction, Heart Failure With Reduced Ejection Fraction, Heart Failure, Right Sided
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2016to 31 Dec 2028
- How long will I take part?
- 50 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Heather Jameson, PhD
Hanna Gaggin, MD, MPH
About this study
Official title: Preserved vs. Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Heart Failure Patients (PREFER-HF) Study
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.
Read the detailed 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.
- Conditions
- 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
- Keywords
- Heart failure, Precision medicine, High risk patients, Pathophysiology, Bioregistry, Biomarkers, Heart failure etiology
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
MACE as defined by a combined end point of all-cause mortality and HF hospitalizations.
Measured: Time from sample collection until the date of documented event up to 60 months after the study closure.
Secondary outcomes (7)
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.
Measured: Time from sample collection until the date of documented event up to 60 months after the study closure.
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.
Measured: Time from sample collection until the date of documented event up to 60 months after the study closure.
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.
Measured: Time from sample collection until the date of documented event up to 60 months after the study closure.
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.
Measured: Time from sample collection until the date of documented event up to 60 months after the study closure.
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.
Measured: Time from sample collection until the date of documented event up to 60 months after the study closure.
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.
Measured: Time from sample collection until the date of documented event up to 60 months after the study closure.
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.
Measured: Time from sample collection until the date of documented event up to 60 months after the study closure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start7 Apr 2016
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Normal Ejection FractionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 50 Months
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Principal investigator, Hanna Kim Gaggin, Massachusetts General Hospital
- Investigators
- Hanna Gaggin, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480633
- Sponsor's protocol ID
- 2016P000339
- Acronym
- PREFER-HF
- Status last verified
- Dec 2025
- First submitted
- 22 Feb 2018
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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):e001704. doi: 10.1136/openhrt-2021-001704.
PubMed 34663746
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preserved vs. Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Heart Failure Patients (PREFER-HF) Study
- ClinicalTrials.gov ID
- NCT03480633
- Acronym / sponsor ID
- PREFER-HF / 2016P000339
- Conditions
- 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
- Keywords
- Heart failure, Precision medicine, High risk patients, Pathophysiology, Bioregistry, Biomarkers, Heart failure etiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 7 Apr 2016 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 50 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (12 listed)
- 18 years and older
- History of clinical symptoms consistent with HF and at least one of the following supporting evidence of HF:
- HFpEF: LVEF ≥ 50% HFrEF: LVEF <50%
- End stage renal disease on dialysis
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Derived from this study: PubMed 34663746Abboud 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):e001704. doi: 10.1136/openhrt-2021-001704.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanna Gaggin, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Normal Ejection Fraction and Heart Failure With Reduced Ejection Fraction, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abbie Macher, BS (617-643-6328, ajmacher@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.