The new Diastolic Heart Failure Program at Brigham and Women’s Hospital (BWH) has been established to help physicians provide improved patient care, learn more about the disease, and to identify more effective therapies. Michael M. Givertz, MD, Co-Director of the Cardiomyopathy and Heart Failure Program, says, “We are learning that diastolic heart failure is not a homogeneous disorder, but rather is comprised of a number of clinical entities including hypertensive heart disease and hypertrophic, restrictive and infiltrative cardiomyopathies, among others. As we learn more about diastolic heart failure, we expect to be able to develop and offer more effective therapies by optimizing medications and disease management strategies.”
There are some five million heart failure patients in the United States, and approximately 40 percent of those suffer from diastolic heart failure. Despite these numbers, the prevalence of diastolic heart failure remains under- recognized, the seriousness of the prognosis remains under-appreciated, and the pathophysiology and best therapeutic strategies remain under-studied.
Time for Action
Kenneth L. Baughman, MD, Director of BWH’s Advanced Heart Disease Program says, “Under the auspices of our Advanced Heart Disease Program, we have a long experience of treating diastolic heart failure. With our emerging understanding of the prevalence and the seriousness of this disease, the time is right for our new initiative to make a positive impact on this very important category of heart failure.”
Multidisciplinary Collaboration
BWH is uniquely prepared to undertake this effort. The Cardiovascular Center comprises physicians with special expertise in the management of advanced heart failure, interventional cardiology, cardiac imaging, and cardiac pathology, as well as experienced clinical investigators. In addition, clinicians will collaborate with basic science investigators to try to study diastolic heart failure on a cellular level. They also will work closely with physicians and scientists in BWH’s Cardiovascular Genetics Center to identify any genetic factors involved in the development of diastolic heart failure.
Expanded Database
Amassing a complete database will be critical to the success of the Program. Physicians have agreed on a core set of data that are important to understanding the clinical, pathophysiological, and biological differences between systolic and diastolic heart failure, between a diastolic failure heart and a normal heart, and between one diastolic heart failure patient and another. These data will augment an existing heart failure database and will include supplemental data and follow-up observations specific to the study of diastolic heart failure. The physicians anticipate that this information will be invaluable in tailoring therapies to be most effective for each individual patient.
Innovative Therapies
The goals of treatment, as for systolic heart failure patients, are to relieve symptoms, improve quality-of-life and slow disease progression by reducing hospitalizations and death. To those ends, the program offers a number of innovative treatment strategies – including tailored therapy and ultrafiltration – to benefit patients with diastolic heart failure. Patients who are not responding to oral medications may be monitored in the hospital with pulmonary artery catheters to gather specific information about their individual disease characteristics. For diastolic heart failure patients, the medications usually include diuretics and vasodilators. Based on these findings, medication regimes are changed or titrated. When the patient’s disease is controlled, they convert to oral therapy. Ultrafiltration therapy may be beneficial for patients with refractory heart disease, poor kidney function, and fluid overload. Through peripheral intravenous catheters, up to 500 cc of fluid per hour can be mechanically removed. The device is used over a period of a few days, after which patients can generally be managed with standard therapy. During the hospital stay, opportunities exist for managing abnormalities of cardiac rate and rhythm and evaluating co-morbidities such as anemia, pulmonary hypertension and sleep apnea.
Clinical trials. Currently, BWH patients are participating in several promising trials of new therapy for diastolic heart failure:
- UNLOAD compares outcomes for patients treated with ultrafiltration to those of patients receiving standard therapy.
- COMPASS is assessing the effectiveness of an implantable hemodynamic monitor for managing fluid status in ambulatory heart failure patients.
- NovaCardia Study aims to assess the role of adenosine receptor blockade in hospitalized patients with volume overload and diuretic resistance.
In addition, Brigham and Women’s Hospital, along with New England Research Institutes, Inc., will be the Clinical Trial Coordinating Center for TOPCAT, an international multicenter trial of aldosterone receptor blockade to treat heart failure patients with preserved systolic function.
Scott Solomon, MD, BWH Director of Noninvasive Cardiology, says, “Almost half of patients with heart failure have a relatively normal ejection fraction – yet beyond symptom relief there is no therapy that has been shown to reduce morbidity or mortality in these patients. The TOPCAT trial will determine whether spironolactone, a drug that has been shown to have substantial benefit in patients with heart failure and reduced ejection fraction, will improve outcomes in this population. It is our hope that this trial will lead to new therapies for this undertreated patient population.” Study sponsors expect to enroll 4,500 patients in TOPCAT. Eligibility criteria include: age 50 years or older; heart failure with left ventricular ejection fraction greater than 45 percent; controlled systolic blood pressure; serum potassium level less than 5 mmol/L. The primary endpoint is a composite of cardiovascular mortality and aborted cardiac arrest or hospitalization for the management of heart failure.
For more information about TOPCAT and enrolling a patient, please contact Dr. Eldrin Lewis at (617) 525-7057.
Indications for Referral
The Diastolic Heart Failure Program provides evaluation and treatment for patients who have clinical symptoms of heart failure and a preserved ejection fraction. Those who are particularly appropriate for an evaluation are:
- Patients that have been newly diagnosed;
- Patients that have recently been hospitalized;
- Patients that are refractory to current therapy;
- Patients that have related cardiac issues;
- Patients that may be eligible for investigational protocols.
Patient evaluation will include:
- Detailed history and physical examination;
- Laboratory tests including cardiac and renal biomarkers;
- Non-invasive imaging including echocardiography and exercise stress testing;
- Assessment of vascular stiffness.
Some patients may be referred for additional imaging or invasive testing such as cardiac catheterization, heart biopsy, and electrophysiology studies. Based on the findings, physicians develop customized management plans for patients.
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