The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Synvista Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00043836
First received: August 14, 2002
Last updated: September 1, 2009
Last verified: August 2007
  Purpose

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.


Condition Intervention Phase
Heart Failure, Congestive
Dyspnea
Pulmonary Edema
Drug: ALT-711
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Of ALT-711 In Elderly Patients With Isolated Diastolic Heart Failure: The DIAMOND Study

Resource links provided by NLM:


Further study details as provided by Synvista Therapeutics, Inc:

Estimated Enrollment: 20
Study Start Date: July 2002
Study Completion Date: October 2005
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043836

Locations
United States, North Carolina
Wake Forest University Baptist Medical Center, Department of Cardiology
Winston-Salem, North Carolina, United States, 27157-1045
United States, South Carolina
Medical University of South Carolina and Ralph H. Johnson VA Medical Center
Charleston, South Carolina, United States, 29425 and 29401
Sponsors and Collaborators
Synvista Therapeutics, Inc
Investigators
Principal Investigator: Dalane W Kitzman, MD Associate Professor of Medicine and Cardiology, Wake Forest University Baptist Medical Center
Principal Investigator: Michael R Zile, MD Charles Ezra Daniel Professor of Medicine, Medical University of South Carolina
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00043836     History of Changes
Other Study ID Numbers: ALT-711-0214
Study First Received: August 14, 2002
Last Updated: September 1, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Synvista Therapeutics, Inc:
ejection fraction
exercise tolerance
heart failure, congestive
quality of life

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Pulmonary Edema
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014