Congestive Heart FailurePEARL-HFNCT02632656
Plasma ExtrAcellular RNAs and Biomarkers of Heart FaiLure During Decongestion: PEARL-HF Study
An observational study of Congestive Heart Failure, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The primary objective is to measure the association between extracellular RNA (ex-RNA) levels in plasma in patients receiving aggressive outpatient therapy for CHF with (1) cardiac remodeling and (2) cardiovascular events. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Monitoring on heart failure therapy
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 1 Dec 2027
- 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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of 200 eligible subjects. These subjects will be enrolled from the Massachusetts General Heart Failure Center population, from the Yawkey Center for Outpatient Care, upon discharge from the inpatient services at Massachusetts General Hospital.
Who may be able to join
- Age > 21 years of age
- Left ventricular ejection fraction ≤ 50% (at any time in the past)
- Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level)
- Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment
Who cannot join
- Severe renal insufficiency defined as serum creatinine > 2.5 mg/dl
- United Organ Network Sharing status 1B for heart transplantation (outpatient inotrope use, LV assist device)
- Inoperable aortic valvular heart disease
- Life expectancy <1 year due to causes other than HF such as advanced cancer
- Cardiac transplantation or revascularization indicated or expected within 6 months
- Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec <1 L (when diagnosed as standard of care)
- Subject unable or unwilling to provide written informed consent
- Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The primary objective is to measure the association between extracellular RNA (ex-RNA) levels in plasma in patients receiving aggressive outpatient therapy for CHF with (1) cardiac remodeling and (2) cardiovascular events. The investigators will follow patients during standard medical therapy for CHF to assess changes in ex-RNA levels in the plasma, and how these are associated with cardiac remodeling (by cardiac imaging) and outcomes.
Read the detailed description
Nearly 5 million people in the United States have congestive heart failure (CHF). Although medical therapy such as beta-blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs) and aldosterone antagonists has improved prognosis, the overall rate of hospital admissions has continued to rise in the last decade and the mortality for patients with symptomatic heart failure remains worse than the majority of cancers in this country. Accordingly, significant opportunities exist for the improvement in outcomes of patients with CHF, both from a morbidity and mortality standpoint. Such opportunities may lie in the outpatient medical management of patients with CHF.
In this study, the primary objective is to measure the association between extracellular RNA (ex-RNA) levels in plasma in patients receiving aggressive outpatient therapy for CHF with (1) cardiac remodeling and (2) cardiovascular events. The investigators will follow patients during standard medical therapy for CHF to assess changes in ex-RNA levels in the plasma, and how these are associated with cardiac remodeling (by cardiac imaging) and outcomes.
- Conditions
- Congestive Heart Failure
- Being tested
- Monitoring on heart failure therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring on heart failure therapyOther
This is a prospective observational study where participants will have serial blood collection on medical therapy for heart failure.
| Study group | Role | What they receive |
|---|---|---|
| Patients with congestive heart failure | Patients with congestive heart failure (CHF) who are followed in the hospital or clinic setting, with optimization of medical therapy Receives: Other: Monitoring on heart failure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to death
Measured: 24 months
Time to decompensated heart failure (HF) requiring in-patient admission or ER visit or IV diuretic therapy in the outpatient realm
- New onset of classic symptoms and signs of destabilized HF, including lower extremity edema, jugular venous distension, bibasilar crackles, orthopnea and paroxysmal nocturnal dyspnea
Measured: 24 months
Time to acute coronary syndrome
Myocardial infarction
Measured: 24 months
Time to stroke or transient ischemic attack
Measured: 24 hours
Time to ventricular arrhythmia
Clinically significant ventricular arrhythmia, defined as ventricular arrhythmia plus one of the following:
Measured: 24 months
Secondary outcomes (2)
Change in left ventricular (LV) end-systolic volume (in %)
Measured: 12 months
Change in LV ejection fraction (%)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Saumya Das, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632656
- Sponsor's protocol ID
- 2015P001658
- Acronym
- PEARL-HF
- Status last verified
- Jun 2026
- First submitted
- 11 Dec 2015
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma ExtrAcellular RNAs and Biomarkers of Heart FaiLure During Decongestion: PEARL-HF Study
- ClinicalTrials.gov ID
- NCT02632656
- Acronym / sponsor ID
- PEARL-HF / 2015P001658
- Conditions
- Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- Dec 2015
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Dec 2015 (estimated)
- 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.
The primary objective is to measure the association between extracellular RNA (ex-RNA) levels in plasma in patients receiving aggressive outpatient therapy for CHF with (1) cardiac remodeling and (2) cardiovascular events. The investigators will follow patients during standard medical therapy for CHF to assess changes in ex-RNA levels in the plasma, and how these are associated with cardiac remodeling (by cardiac imaging) and outcomes.
Detailed description
Nearly 5 million people in the United States have congestive heart failure (CHF). Although medical therapy such as beta-blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs) and aldosterone antagonists has improved prognosis, the overall rate of hospital admissions has continued to rise in the last decade and the mortality for patients with symptomatic heart failure remains worse than the majority of cancers in this country. Accordingly, significant opportunities exist for the improvement in outcomes of patients with CHF, both from a morbidity and mortality standpoint. Such opportunities may lie in the outpatient medical management of patients with CHF.
In this study, the primary objective is to measure the association between extracellular RNA (ex-RNA) levels in plasma in patients receiving aggressive outpatient therapy for CHF with (1) cardiac remodeling and (2) cardiovascular events. The investigators will follow patients during standard medical therapy for CHF to assess changes in ex-RNA levels in the plasma, and how these are associated with cardiac remodeling (by cardiac imaging) and outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with congestive heart failure | – | Other: Monitoring on heart failure therapyPatients with congestive heart failure (CHF) who are followed in the hospital or clinic setting, with optimization of medical therapy |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 200 eligible subjects. These subjects will be enrolled from the Massachusetts General Heart Failure Center population, from the Yawkey Center for Outpatient Care, upon discharge from the inpatient services at Massachusetts General Hospital.
Key inclusion criteria (4 listed)
- Age > 21 years of age
- Left ventricular ejection fraction ≤ 50% (at any time in the past)
- Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level)
- Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment
Key exclusion criteria (8 listed)
- Severe renal insufficiency defined as serum creatinine > 2.5 mg/dl
- United Organ Network Sharing status 1B for heart transplantation (outpatient inotrope use, LV assist device)
- Inoperable aortic valvular heart disease
- Life expectancy <1 year due to causes other than HF such as advanced cancer
- Cardiac transplantation or revascularization indicated or expected within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring on heart failure therapyThis is a prospective observational study where participants will have serial blood collection on medical therapy for heart failure. | Other | Patients with congestive heart failure |
Primary outcome
Time to death
Time frame: 24 months
Time to decompensated heart failure (HF) requiring in-patient admission or ER visit or IV diuretic therapy in the outpatient realm
Time frame: 24 months
• New onset of classic symptoms and signs of destabilized HF, including lower extremity edema, jugular venous distension, bibasilar crackles, orthopnea and paroxysmal nocturnal dyspnea
Time to acute coronary syndrome
Time frame: 24 months
Myocardial infarction
Time to stroke or transient ischemic attack
Time frame: 24 hours
Time to ventricular arrhythmia
Time frame: 24 months
Clinically significant ventricular arrhythmia, defined as ventricular arrhythmia plus one of the following:
2 secondary outcomes
Change in left ventricular (LV) end-systolic volume (in %)
Time frame: 12 months
Change in LV ejection fraction (%)
Time frame: 12 months
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 17 Jun 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Congestive Heart Failure, 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to death (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.