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

September 1, 2009 updated by: Synvista Therapeutics, Inc

A Pilot Study Of ALT-711 In Elderly Patients With Isolated Diastolic Heart Failure: The DIAMOND Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1045
        • Wake Forest University Baptist Medical Center, Department of Cardiology
    • South Carolina
      • Charleston, South Carolina, United States, 29425 and 29401
        • Medical University of South Carolina and Ralph H. Johnson VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (Actual)

February 1, 2003

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

August 14, 2002

First Submitted That Met QC Criteria

August 14, 2002

First Posted (Estimate)

August 15, 2002

Study Record Updates

Last Update Posted (Estimate)

September 2, 2009

Last Update Submitted That Met QC Criteria

September 1, 2009

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALT-711-0214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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