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Congestive Heart Failure (CHF) is a major public health problem. The National Heart, Lung, and Blood Institute estimates that over 4.7 million Americans have CHF and that about 400,000 new cases are diagnosed each year. Over 200,000 Americans die of CHF every year. This translates into a huge depletion in terms of quality of life, productivity, and finances. Almost 1 million hospitalizations occur each year from CHF, at an estimated cost of over $7 billion. In 1990 alone, total treatment costs for heart failure, including physician visits, drugs, and nursing home stays, were over $10 billion. Patients who are diagnosed with CHF must understand the serious implications of this disease. Some clinical studies have shown that the five-year mortality rate approaches 50%.
The interactive role of each patient participating in a research trial is critical to the overall clinical outcome. The program is patient-driven in that patients are educated on their options, potential benefits and adverse effects of the drug in question, and are asked to sign a detailed informed consent, prior to administration of the drug. Concurrent medication doses may be adjusted as per protocol requirements. Patients are asked to return to the office for scheduled visits with the doctor/research coordinator, and regular blood draws/EKG’s. They are required to take the study medication as advised; bring the study medication with them on each visit; keep a diary recording the start and stop dates for the drug; and notify the research coordinator in the event of any perceived side -effect or any hospitalization. If you are a primary care physician or a cardiologist and are interested in obtaining additional information on one or more trials, or if you have a patient who you feel may benefit from participation in a heart failure trial, please contact the Research Department at (480) 545-1832, or e-mail us at bobbie.boyd@acs-im.com. If you are suffering from heart failure and are interested in learning more about your clinical condition, or would like more information regarding opportunities for participation in research, please contact the Research Department at (480) 545-1847, or e-mail us at bobbie.boyd@acs-im.com.
List of Heart Failure
Trials Currently Enrolling Patients This trial randomizes patients to treatment with a conventional ACE-inhibitor (lisinopril) or to a newer drug, which combines ACE -inhibition with inhibition of neutral endopeptidase (NEP/ACE). The new component potentiates the effects of a hormone produced by the left atrium (heart) and increases sodium (and fluid) excretion via the kidneys. This combination is expected to be more effective in treating advanced heart failure. Patients have an exercise treadmill test at baseline (prior to starting the research drug), at 12 weeks and at 24 weeks, to objectively assess improvement in their functional status. The study duration is 24 weeks, but patients are likely to continue to receive the drug in an extended, open-label phase, until the drug is commercially available. Sponsor: Bristol-Myers Squibb Pharmaceutical Research Institute, 1997 to present. NEP/ACE CV137-018: This trial evaluates the effectiveness and tolerability of long-term treatment with NEP-ACE (see above) in subjects with advanced heart failure and atrial fibrillation, by randomizing patients to receive either this drug or lisinopril, and comparing outcomes in the two groups. The study duration is 52 weeks, after which all patients will receive the NEP/ACE drug in an open-label phase, until the drug is commercially available on regular prescription. Sponsor: Bristol-Myers Squibb Pharmaceutical Research Institute, 1997 to present. VALSARTAN 107: This is a multicenter, randomized, double-blind, placebo -controlled trial to assess the effect of a new Angiotensin- receptor antagonist, Valsartan, on morbidity and mortality, clinical status, and quality of life in patients with chronic, Congestive Heart Failure (Phase III). The duration of the study is 36 months. Sponsor: Novartis (Ciba-Geigy Corporation), 1997 to present. PRAISE II: Amlodipine is a newer calcium-channel blocking agent, which has been shown in an earlier trial (PRAISE – I) to be beneficial in heart failure of non-ischemic origin (i.e. the heart failure is not associated with significant coronary artery disease). PRAISE – II randomizes patients with proven non-ischemic cardiomyopathy to treatment with Amlodipine versus placebo, and follows them over a period of 2.5 years. Sponsor: Pfizer Pharmaceuticals / Duke Clinical Research Institute, 1995 to present. |
