NCT03480633 Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure
| NCT ID | NCT03480633 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Heart Failure With Normal Ejection Fraction |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2016-04-07 |
| Primary Completion | 2026-04-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2016-04-07 with a primary completion date of 2026-04-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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) 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
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
Contact & Investigator
Hanna Gaggin, MD, MPH
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT03480633 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Normal Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03480633 currently recruiting?
Yes, NCT03480633 is actively recruiting participants. Contact the research team at ajmacher@mgh.harvard.edu for enrollment information.
Where is the NCT03480633 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT03480633 clinical trial?
NCT03480633 is sponsored by Massachusetts General Hospital. The principal investigator is Hanna Gaggin, MD, MPH at Massachusetts General Hospital. The trial plans to enroll 3,000 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.