Effect of Valsartan in Ventricular Function and Aortic Elasticity
| ISRCTN | ISRCTN10318149 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10318149 |
| Secondary identifying numbers | 2002P-000067 |
- Submission date
- 20/01/2006
- Registration date
- 17/05/2006
- Last edited
- 11/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Aristidis Veves
Scientific
Scientific
330 Brookline Avenue
Palmer 321
Boston
02215
United States of America
Study information
| Study design | This is a randomized, double-blind, placebo-controlled, crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Effect of Valsartan in Ventricular Function and Aortic Elasticity |
| Study objectives | The primary hypothesis is that left ventricular function is impaired in diabetes, even in the absence of coronary artery disease. Protein kinase C (PKC) activation and endothelial dysfunction are the main factors that have been implicated in this. Valsartan may improve left ventricular function in the early stages and therefore, can be of help in patients without clinical cardiac abnormalities. |
| Ethics approval(s) | Yes, first approved 23/01/2003 |
| Health condition(s) or problem(s) studied | Diabetes mellitus type 2 |
| Intervention | Participants will be followed up for approximately 14 months. Each participant will be randomized to either placebo or Valsartan 160 mg/day for the first six months and then given the opposite treatment for the next six months. An eight-week wash out period (up to 4-6 months) will separate the two treatment periods. MRI of the heart and aorta will be performed at baseline and the end of each period of the study. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Valsartan |
| Primary outcome measure | Changes in aortic elasticity (arterial compliance, stiffness index and pulse wave velocity) measured by MRI |
| Secondary outcome measures | Changes in ventricular function (the volumetric assessment of mass, end-diastolic and end-systolic volumes, ejection fraction (EF), stroke volume and cardiac output of the left and the right ventricles) |
| Overall study start date | 26/02/2003 |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 24 |
| Key inclusion criteria | We plan to study two groups with 15 subjects each: 1. Healthy non-diabetic subjects 2. Patients with type 2 diabetes with no severe long-term diabetes complications For inclusion in the trial, patients must fulfil all of the following criteria: 1. All subjects will be ages 21-80 years 2. Healthy subjects - subjects should not be considered at higher risk than the general population to develop type 2 diabetes according to one of the following criteria: a. Fasting plasma glucose <100 mg/dl and/or a 2-hour plasma glucose <140 during 75 gm oral glucose tolerance test (OGTT) 3. Patients with type 2 diabetes with no serious long-term complications 4. Individuals with a diagnosis of type 2 diabetes according to the American Diabetes Association criteria below, established in 1998. Subjects previously diagnosed with type 2 diabetes will not require a repeated diagnostic testing. a. Unequivocal elevated plasma glucose level >200 mg/dl with symptoms suggestive of hyperglycemia (polyuria, polydipsia, weight loss) b. Fasting plasma glucose levels >126 mg/dl c. Two-hour plasma glucose >200 mg/dl during a 75 gm OGTT In the absence of unequivocal hyperglycemia with acute metabolic decompensation, these criteria should be confirmed by repeat testing on a different day. 5. Prior to participation in this study, each subject must sign an informed consent form |
| Key exclusion criteria | Active or uncontrolled cardiovascular disease as follows: a. Coronary artery disease (CAD) (known CAD with previous diagnosis of definite acute myocardial infarction, unstable angina or stable angina) b. Arrhythmia (uncontrolled, highly symptomatic, requires treatment or life-threatening) c. Congestive heart failure (CHF) (New York Heart Association function class III and IV - symptoms of heart failure on less than ordinary exertion or at rest) d. Stroke or transient ischemic attack with residual neurological damage e. Uncontrolled hypertension: systolic blood pressure (SBP) >180 mmHg or diastolic blood pressure (DBP) >105 mmHg (two abnormal readings during visit) f. Hypotension 2. Liver disease (alanine aminotranferease (ALT), aspartate aminotransferase (AST), alkaline phosphate levels >2 times upper normal limit) at the time of enrolment 3. Renal disease (macro-albuminuria) (2 of 3 urine specimens collected within a 3-6 month period with urine albumin ≥300 ug/mg creatinine - according to the American Diabetes Association (ADA) position statement) 4. Severe dyslipidemia (triglycerides >600 mg/dl or cholesterol >350 mg/dl). Subjects with hypertriglyceridemia may be re-tested in 2-3 weeks as the values can fluctuate tremendously within a few days. In the event that the re-tested value allows the patient to be enrolled, a planned deviation will be submitted to the Cardiovascular Credentialing International (CCI). 5. Any other serious chronic disease requiring active treatment 6. Females of childbearing potential not using an effective form of birth control as determined by the investigators 7. Subjects on any of the following medications: a. Angiotensin II receptor antagonist treatment during last 3 months b. Systemic glucocorticoids c. Antineoplastic agents d. Bronchodilators (aminophyline, inhaled beta agonists) on a regular basis 8. Claustrophobia 9. Subjects unable to have magnetic resonance imaging (MRI) scan according to the MRI clinical standards such as a pacemaker, defibrillator, eye implants and other metal implants or devices |
| Date of first enrolment | 26/02/2003 |
| Date of final enrolment | 30/06/2007 |
Locations
Countries of recruitment
- United States of America
Study participating centre
330 Brookline Avenue
Boston
02215
United States of America
02215
United States of America
Sponsor information
Beth Israel Deaconess Medical Centre (USA)
Hospital/treatment centre
Hospital/treatment centre
330 Brookline Avenue
Palmer 321
Boston
02215
United States of America
"ROR" |
https://ror.org/04drvxt59 |
|---|
Funders
Funder type
Industry
Novartis Pharmaceuticals
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2009 | 11/01/2021 | Yes | No |
Editorial Notes
11/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
