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The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure Clinical research trials and The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure. The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure clinical trial. Participants frequently obtain the most expert healthcare available for their The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure  The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure
The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure
For Condition: Dyspnea,Heart Failure, Congestive,Pulmonary Edema
Status: No longer recruiting
Sponsor(s): Alteon Inc. ,
Synopsis: The purpose of this study is to test the hypothesis that treatment with oral ALT-711 twice daily for 16 weeks will improve aortic distensibility, exercise tolerance, and quality of life in elderly patients with isolated diastolic heart failure (DHF), and that the improvements in exercise tolerance will correlate with the improvements in aortic distensibility.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 60 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 1. Men or women 60 years of age. 2. Diagnosis of congestive heart failure with one or both of the following criteria: a Heart Failure Clinical Score 3 based on the NHANES-I criteria and/or a history of either acute pulmonary edema or the occurrence of 2 or more of the following with subsequent improvement with diuretic therapy and with no other identifiable cause: dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, systemic edema, exertional fatigue. 3. Left ventricular ejection fraction 50% based on the baseline Doppler echocardiography test. 4. Ability to provide written informed consent. 5. Ability to comply with procedures specified in the study protocol. Exclusion Criteria 1. Valvular heart disease as the primary etiology of congestive heart failure. 2. Significant change in cardiovascular medication(s) <3 weeks prior to the baseline visit. 3. Uncontrolled hypertension. 4. History of stroke, or any sequelae of a transient ischemic attack (TIA), reversible ischemic neurologic defect (RIND), or stroke, within the last 12 months prior to entry into the study. 5. Cancer or other noncardiovascular conditions with life expectancy less than 2 years. 6. Significant anemia defined as a hemoglobin <11 gm/dL. 7. Significant renal insufficiency defined as a serum creatinine >2.5 mg/dL. 8. Significant hepatic insufficiency defined as an SGPT (ALT) or SGOT (AST) >2.5 times the upper limit of normal. 9. Psychiatric disease (including uncontrolled major psychoses, depression, dementia, or personality disorder) or any additional condition(s) which, in the investigator’s opinion, would prohibit the patient from completing the study, or not be in the best interest of the patient. 10. Presence or history of drug or alcohol abuse. 11. Prior exposure to ALT-711 or use of any other investigational drugs within 30 days prior to screening. 12. Known seropositivity for HIV or hepatitis C, or presence of hepatitis B surface antigen. 13. Severe COPD requiring recurrent oral steroids, oxygen at home or more than one inhaler. 14. Baseline echocardiogram demonstrating the presence of left ventricular ejection fraction <50%. 15. Unstable or uncontrolled myocardial ischemia, with no wall abnormality. 16. Screening Familiarization Exercise Test demonstrating the presence of any of the following findings: evidence of significant ischemia (consisting of ECG finding of > 1 mm flat ST depression confirmed with echocardiogram wall motion, or wall motion abnormality or decrease in global contractility on echocardiogram, or inability to continue exercising due to significant chest or leg pain or any reason other than exhaustion/fatigue/dyspnea, exercise SBP >240 mm Hg, DBP >110 mmHg, unstable hemodynamics or rhythm, or unwilling or unable to complete test adequately. 17. Any contraindications to magnetic resonance imaging including but not limited to indwelling metal-containing prosthesis (orthopedic, valvular, other), pacemaker or defibrillator, history of welding occupation (ocular metal debris), or uncontrollable claustrophobia.
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
DalaneKitzman, Principal Investigator, Associate Professor of Medicine and Cardiology, Wake Forest University Baptist Medical Center
Wake Forest University Baptist Medical Center, Department of Cardiology
Winston Salem, North Carolina, 27157-1045
United States
Medical University of South Carolina and Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29425 and 29401
United States
Additional Information:
Study ID Numbers: ALT-711-0214;
Study Start Date: July 2002
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043836
Other Heart Failure, Congestive Studies:
1. The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure
Related Studies:
Other Heart Failure, Congestive Clinical Trials
Other South Carolina Clinical Trials
Other Charleston Clinical Trials
The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure
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