Trial · NCT01206062
Systolic Blood Pressure Intervention Trial
NCT01206062, Not applicable, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2017-12-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Systolic Blood Pressure Intervention Trial. Trials, record NCT01206062. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01206062
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Systolic Blood Pressure Intervention Trial
- NCT number
- NCT01206062
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 9,361 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Hypertension
- Interventions
- Intensive control of SBP, Standard control of SBP
- First posted
- 2010-09-21
- Last updated
- 2021-01-08
- Results first posted
- 2017-12-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death | 6 years | |
| Secondary | Number of Participants With All-cause Mortality | 6 years | |
| Secondary | Number of CKD Participants Who Experienced a 50% Decline From Baseline eGFR | 6 years | |
| Secondary | Participants Who Developed End Stage Renal Disease | 6 years | |
| Secondary | Number of Patients With All-cause Dementia | 6 years | A 3-step process was used ascertain incident cases of all-cause dementia. First, to identify possible cases of dementia a brief Cognition Screening Battery was administered to all participants. Participants who score below the pre-designated screening cut-point for possible cognitive impairment during follow-up were administered a more comprehensive and detailed neurocognitive test battery (the Extended Cognitive Assessment Battery) plus the Functional Assessment Questionnaire (FAQ) which assesses impairments in daily living skills as a result of cognitive impairments. Last, all the above available tests and questionnaire data were submitted to a centralized, web-based system for adjudication by a panel of dementia experts who assigned final study classifications of probable dementia (PD), mild cognitive impairment (MCI) or no impairment (NI). |
| Secondary | Small Vessel Cerebral Ischemic Disease | 4 years | Change over 4 years in total white matter lesion volume from baseline Change over 4 years in total brain volume from baseline Because of the skewed distribution for WML volume, we first applied an inverse hyperbolic sine transformation (asinh), which is similar to a log transformation but can accommodate values of zero. Linear mixed models, including random effects for participant and MRI facility, were used to estimate the change in WML volume and TBV between the treatment groups, including time since randomization (in days) and intracranial volume as covariates. Because the inverse hyperbolic sine transformation is nonlinear, and given the context of a mixed-effects model, back-transformation to the original scale of cm3 is difficult |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death | 6 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With All-cause Mortality | 6 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of CKD Participants Who Experienced a 50% Decline From Baseline eGFR | 6 years | Participants with CKD at baseline | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Developed End Stage Renal Disease | 6 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients With All-cause Dementia | 6 years | Participants who completed at least 1 cognitive assessment during follow-up | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Small Vessel Cerebral Ischemic Disease | 4 years | Of the 670 participants with WML volume measurement at baseline, 462 completed the follow-up MRI. Image quality control requirements were not met for 13 participants with a follow-up MRI scan, resulting in a sample of 449 adults. | asinh(cm3) | 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 |
|---|---|---|---|---|---|
| Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death | Intensive Control of SBP | 243 | Participants | ||
| Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death | Standard Control of SBP | 319 | Participants | ||
| Number of Participants With All-cause Mortality | Intensive Control of SBP | 155 | Participants | ||
| Number of Participants With All-cause Mortality | Standard Control of SBP | 210 | Participants | ||
| Number of CKD Participants Who Experienced a 50% Decline From Baseline eGFR | Intensive Control of SBP | 10 | Participants | ||
| Number of CKD Participants Who Experienced a 50% Decline From Baseline eGFR | Standard Control of SBP | 12 | Participants | ||
| Participants Who Developed End Stage Renal Disease | Intensive Control of SBP | 12 | Participants | ||
| Participants Who Developed End Stage Renal Disease | Standard Control of SBP | 8 | Participants | ||
| Number of Patients With All-cause Dementia | Intensive Control of SBP | 149 | Participants | ||
| Number of Patients With All-cause Dementia | Standard Control of SBP | 176 | 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 | Intensive Control of SBP | 4,678 | |
| Overall Study | STARTED | Standard Control of SBP | 4,683 | |
| Overall Study | COMPLETED | Intensive Control of SBP | 4,678 | |
| Overall Study | COMPLETED | Standard Control of SBP | 4,683 | |
| Overall Study | NOT COMPLETED | Intensive Control of SBP | 0 | |
| Overall Study | NOT COMPLETED | Standard Control of SBP | 0 |
Source ClinicalTrials.gov
Adverse events72
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 | Hypotension | Cardiac disorders | Intensive Control of SBP | 48 | 4,678 | |
| other | Hypotension | Cardiac disorders | Standard Control of SBP | 27 | 4,683 | |
| other | Syncope | Nervous system disorders | Intensive Control of SBP | 56 | 4,678 | |
| other | Syncope | Nervous system disorders | Standard Control of SBP | 33 | 4,683 | |
| other | Bradycardia | Vascular disorders | Intensive Control of SBP | 17 | 4,678 | |
| other | Bradycardia | Vascular disorders | Standard Control of SBP | 10 | 4,683 | |
| other | Electrolyte Abnormality | General disorders | Intensive Control of SBP | 33 | 4,678 | |
| other | Electrolyte Abnormality | General disorders | Standard Control of SBP | 22 | 4,683 | |
| other | Injurious fall | General disorders | Intensive Control of SBP | 229 | 4,678 | |
| other | Injurious fall | General disorders | Standard Control of SBP | 222 | 4,683 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intensive Control of SBP | 155 | 4,678 |
| Total, all-cause mortality | Standard Control of SBP | 210 | 4,683 |
| Total, other adverse events | Intensive Control of SBP | 1,399 | 4,678 |
| Total, other adverse events | Standard Control of SBP | 1,342 | 4,683 |
| Total, serious adverse events | Intensive Control of SBP | 1,793 | 4,678 |
| Total, serious adverse events | Standard Control of SBP | 1,736 | 4,683 |
Source ClinicalTrials.gov
Papers137
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intensive Control of SBP vs Standard Control of SBP: Number of CKD Participants Who Experienced a 50% Decline From Baseline eGFR | Trial comparisons |
| Intensive Control of SBP vs Standard Control of SBP: Number of Patients With All-cause Dementia | Trial comparisons |
| Intensive Control of SBP vs Standard Control of SBP: Number of Participants With All-cause Mortality | Trial comparisons |
| Intensive Control of SBP vs Standard Control of SBP: Participants Who Developed End Stage Renal Disease | Trial comparisons |
Intensive Control of SBP vs Standard Control of SBP: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death | Trial comparisons |
| Intensive Control of SBP vs Standard Control of SBP: deaths from any cause | Trial comparisons |
| Intensive Control of SBP vs Standard Control of SBP: 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/NCT01206062
GET https://conductscience.org/api/trials/v1/NCT01206062/events?page=2