Trial · NCT00319982
Treatment of Preclinical Hypertrophic Cardiomyopathy With Diltiazem
NCT00319982, Phase 2, Phase 3, Completed, Brigham and Women's Hospital; results first posted 2015-04-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Preclinical Hypertrophic Cardiomyopathy With Diltiazem. Trials, record NCT00319982. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00319982
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Preclinical Hypertrophic Cardiomyopathy With Diltiazem
- NCT number
- NCT00319982
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 39 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Hypertrophic Cardiomyopathy
- Interventions
- Diltiazem, Placebo
- First posted
- 2006-04-27
- Last updated
- 2015-04-07
- Results first posted
- 2015-04-07
- Limitations and caveats
Small number of participants and short follow-up duration. Currently available tools to monitor treatment response/ phenotypic progression are may lack adequate resolution. The penetrance of sarcomere mutations is variable and may not be complete.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Increase, Stability of, or Decrease in the Decline of Diastolic Function as Reflected by the Global Early Myocardial Relaxation (E') Velocity | Baseline and final study visits | The change in E' velocity (difference between final value - baseline value) was compared between participants who received diltiazem and those who received placebo to gauge treatment response. Please note that the total duration on treatment varied between study subjects to maximize time on treatment for the trial. Specifically, subjects that enrolled earliest had the longest duration of treatment; those who enrolled latest had the shortest duration of treatment with a minimum treatment duration of 1 year. All analyses examine the final study visit on treatment to the baseline visit. |
| Secondary | Safety and Tolerability of Diltiazem Treatment | Baseline through final study visits | Adverse events were compared between participants assigned to diltiazem and those assigned to placebo |
| Secondary | Impact of Diltiazem on Heart Rate | Baseline and final study visits | Change in Value (Difference between Final and Baseline Visits) |
| Secondary | Left Ventricular Cavity Size | Baseline and final study visits | Change in Left Ventricular End-Diastolic Diameter z-score (Final Value - Baseline Value) |
| Secondary | Development of Left Ventricular Hypertrophy | Baseline through final study visits | The number of participants who developed overt left ventricular hypertrophy during the duration of the trial was analyzed |
| Secondary | Adherence to Study Medication | Duration of the trial | Adherence to study medication was assessed by pill count |
| Secondary | Impact of Diltiazem on Systolic Blood Pressure | Baseline and final study visits | Change in Value (Difference between Final and Baseline Visits) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Increase, Stability of, or Decrease in the Decline of Diastolic Function as Reflected by the Global Early Myocardial Relaxation (E') Velocity | Baseline and final study visits | cm/sec (difference final-baseline) | MEAN | |
| SECONDARY | Safety and Tolerability of Diltiazem Treatment | Baseline through final study visits | Participants Reporting Adverse Events | NUMBER | |
| SECONDARY | Impact of Diltiazem on Heart Rate | Baseline and final study visits | beats/minute | MEAN | |
| SECONDARY | Left Ventricular Cavity Size | Baseline and final study visits | z-score units | MEAN | |
| SECONDARY | Development of Left Ventricular Hypertrophy | Baseline through final study visits | participants | NUMBER | |
| SECONDARY | Adherence to Study Medication | Duration of the trial | percentage of pills taken | MEDIAN | |
| SECONDARY | Impact of Diltiazem on Systolic Blood Pressure | Baseline and final study visits | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Increase, Stability of, or Decrease in the Decline of Diastolic Function as Reflected by the Global Early Myocardial Relaxation (E') Velocity | I- Diltiazem | -0.06 | Standard Error 0.27 | cm/sec (difference final-baseline) | |
| Increase, Stability of, or Decrease in the Decline of Diastolic Function as Reflected by the Global Early Myocardial Relaxation (E') Velocity | II- Placebo | -0.21 | Standard Error 0.42 | cm/sec (difference final-baseline) | |
| Safety and Tolerability of Diltiazem Treatment | I- Diltiazem | 10 | Participants Reporting Adverse Events | ||
| Safety and Tolerability of Diltiazem Treatment | II- Placebo | 12 | Participants Reporting Adverse Events | ||
| Impact of Diltiazem on Heart Rate | I- Diltiazem | -4.9 | Standard Error 2.2 | beats/minute | |
| Impact of Diltiazem on Heart Rate | II- Placebo | 2.0 | Standard Error 2.6 | beats/minute | |
| Left Ventricular Cavity Size | I- Diltiazem | 0.60 | Standard Error 0.17 | z-score units | |
| Left Ventricular Cavity Size | II- Placebo | -0.53 | Standard Error 0.16 | z-score units | |
| Development of Left Ventricular Hypertrophy | I- Diltiazem | 2 | participants | ||
| Development of Left Ventricular Hypertrophy | II- Placebo | 2 | participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | I- Diltiazem (Active Arm) | 19 | |
| Overall Study | STARTED | II- Placebo | 20 | |
| Overall Study | COMPLETED | I- Diltiazem (Active Arm) | 18 | |
| Overall Study | COMPLETED | II- Placebo | 20 | |
| Overall Study | NOT COMPLETED | I- Diltiazem (Active Arm) | 1 | |
| Overall Study | NOT COMPLETED | II- Placebo | 0 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Shortness of Breath | Cardiac disorders | I- Diltiazem | 6 | 18 | 9 |
| other | Shortness of Breath | Cardiac disorders | II- Placebo | 1 | 20 | 1 |
| other | Lightheadeness | Cardiac disorders | I- Diltiazem | 3 | 18 | 5 |
| other | Lightheadeness | Cardiac disorders | II- Placebo | 5 | 20 | 6 |
| other | Nausea/GI distress | Gastrointestinal disorders | I- Diltiazem | 1 | 18 | 1 |
| other | Nausea/GI distress | Gastrointestinal disorders | II- Placebo | 4 | 20 | 4 |
| other | Fatigue | General disorders | I- Diltiazem | 1 | 18 | 1 |
| other | Fatigue | General disorders | II- Placebo | 2 | 20 | 2 |
| other | Headache | Nervous system disorders | I- Diltiazem | 0 | 18 | 0 |
| other | Headache | Nervous system disorders | II- Placebo | 1 | 20 | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | I- Diltiazem | ||
| Total, all-cause mortality | II- Placebo | ||
| Total, other adverse events | I- Diltiazem | 10 | 18 |
| Total, other adverse events | II- Placebo | 12 | 20 |
| Total, serious adverse events | I- Diltiazem | 0 | 18 |
| Total, serious adverse events | II- Placebo | 0 | 20 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| K23HL078901 | Diagnostic and Treatment Strategies for Preclinical HCM | HO, CAROLYN Y | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2005 to 2009 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| I- Diltiazem vs II- Placebo: Development of Left Ventricular Hypertrophy | Trial comparisons |
| I- Diltiazem vs II- Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00319982
GET https://conductscience.org/api/trials/v1/NCT00319982/registered